Astodrimer - Starpharma
Alternative Names: 3% w/w SPL7013 Gel; Astodrimer sodium; Betadine BV; BETADINE BV Gel; Betafem BV; BRI-7013; Fleurstat BVgel; SPL-7013; VIRALEZE; Viraleze; VivaGel; VivaGel®BVLatest Information Update: 28 Feb 2024
At a glance
- Originator Biomolecular Research Institute
- Developer Aspen Pharmacare; Starpharma; The Scripps Research Institute
- Class Antibacterials; Antivirals; Dendrimers; Peptides
- Mechanism of Action Anion transport protein modulators; Surface antigen modulators
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
- Available For Licensing Yes
Highest Development Phases
- Marketed Bacterial vaginosis; COVID 2019 infections
- Phase I/II Herpes simplex virus infections; HIV infections
- Preclinical Influenza A virus H1N1 subtype; Influenza A virus H3N2 subtype; Middle East respiratory syndrome coronavirus; Respiratory syncytial virus infections; Severe acute respiratory syndrome
- No development reported Conjunctivitis; Human papillomavirus infections; Zika virus infection
Most Recent Events
- 28 Feb 2024 No recent reports of development identified for phase-I development in COVID-2019-infections(Prevention, In volunteers) in Australia (Intranasal, Spray)
- 12 Jun 2023 Starpharma plans to launch astodrimer for Covid-2019 infection in Malaysia
- 05 Jun 2023 Registered for COVID-2019 infections in Malaysia (Intranasal)
Development Overview
Introduction
Astodrimer (SPL 7013) is a dendrimer-based broad-spectrum microbiocide being developed by Starpharma, as ophthalmic drops for the treatment of viral conjunctivitis, and vaginal gel formulation for treatment and prevention of bacterial vaginosis and for the prevention of sexually transmitted infections including Zika virus, and as virucidal nasal spray for prevention and treatment of viral infections including HIV, herpes simplex virus (HSV), human papillomavirus (HPV), adenovirus, H1N1 influenza virus, hepatitis B virus (HBV), SARS-CoV-2. SPL 7013 inactivates the infectious viruses by inhibiting the interaction of human cell receptor proteins with the viral surface proteins or spikes. Astodrimer, a branched macromolecule, was identified by Biomolecular Research Institute (BRI) in Australia. Astodrimer is available as an over-the-counter (OTC) product in Australia, and is also launched in Germany and New Zealand. Astrodrimer is also approved in Asia as an OTC product and launched in the UK for the prevention of bacterial vaginosis. Astodrimer is approved in the EU, Iceland, Liechtenstein, Norway for the treatment of bacterial vaginosis. Astodrimer is launched in Vietnam, Italy, India, Hong Kong, Macau and the UK and approved in Indonesia and Malaysia as an antiviral spray for the treatment of COVID-2019 infections. Astrodimer is under review for the prevention and treatment of bacterial vaginosis in the US. Clinical development for the prevention of bacterial vaginosis is under progress in several countries worldwide. Clinical development for the prevention of HIV infections, COVID-2019 infections and Herpes simplex virus infections is ongoing in Australia. Preclinical development is underway for viral conjunctivitis, influenza virus infections, respiratory syncytial virus infections, Middle East respiratory syndrome and SARS due to coronavirus infection are ongoing in the US, the UK and Australia.
Phase I development of astodrimer for the prevention of HIV infections was conducted in the US, Puerto Rico. Phase I development for the prevention of Herpes-simplex virus infectionswas conducted in the US, Puerto Rico and Kenya. Early research development for the prevention of Human papillomavirus infections and for the treatment of Zika virus infection was conducted in Australia. However, no recent reports of development had been identified for these indications.
Astodrimer is approved and launched in the United kingdom and India for COVID-2019 infections whereas its in preclinical stage of development in the Australia.
As at January 2023, no recent reports of development had been identified for preclinical development in Conjunctivitis in Australia (Ophthalmic, Drops).
As at February 2024, no recent reports of development had been identified for phase-I development in COVID-2019-infections (Prevention, In volunteers) in Australia (Intranasal, Spray).
Company Agreements
In August 2023, Starpharma and Mundipharma has negotiated a commercial settlement agreement in relation to the VivaGel® BV product. Under the terms of settlement, Starpharma will receive a $US4.25M cash payment from Mundipharma. This cash payment is in addition to the $US3.1M in milestones already received from Mundipharma for the product. Starpharma will terminate its VivaGel® BV licence and supply agreements with Mundipharma, regaining all commercial rights to VivaGel® BV, enabling Starpharma to sign new marketing arrangements for the product. In June 2018, Starpharma and Mundipharma entered a licence agreement for the sales and marketing rights to astodrimer for 43 countries in Europe, Russia, the Commonwealth of Independent States (CIS) and the remaining countries in Latin America. Starpharma will receive returns via a revenue share on VivaGel® BV sales and is also eligible to receive signing, launch and other commercial milestones. Under the European deal, eligible milestones total up to A$20.9 million ($US15.5 million), including a A$2.0 million ($US1.5 million) upfront payment. The combination of territories now under licence with Mundipharma means Starpharma is eligible to receive total signing, regulatory and commercial milestones of up to A$33.3 million ($US24.7 million), in addition to receiving revenue share. Earlier, Mundipharma, in May 2018, licensed astodrimer for the Asian, Middle East, African and majority of the Latin American markets. Under the terms of the agreement, Mundipharma will commence regulatory activities in their licensed territory immediately to secure expedited launch of astodrimer. Under the licence, Starpharma will receive returns via a revenue share on astodrimer sales. In addition, Starpharma is eligible to receive signing, regulatory and commercial milestones totalling up to $US9.2 million including a $US1 million upfront payment. The term of the agreement is 15 years and incorporates commercial performance obligations, including minimum annual purchases by Mundipharma. Starpharma retains ownership of the VivaGel® BV trademark and will supply Mundipharma with product. Other commercial terms of the agreement were undisclosed. [1] [2] [3]
In October 2022, Hengan Group entered into a distribution and marketing agreement with Starpharma for VIRALEZE™ in Hong Kong and Macau. Under this distribution agreement of 2-year term, Starpharma will supply VIRALEZE™, while Hengan Group will be responsible for sales, final packing, distribution, and marketing in Hong Kong and Macau. Further financial details were not disclosed. [4]
In December 2021, Starpharma entered into a supply arrangement with Australian-based Healthco Australia (HealthCo) for importation and distribution of astodrimer (VIRALEZE™) antiviral nasal spray in Vietnam. This ongoing agreement with HealthCo is exclusive for Vietnam and follows an initial supply contract for VIRALEZE™ signed in October. This new agreement incorporates a commitment to purchase a minimum of at least 1 million units of VIRALEZE™ in the first year, with ongoing performance obligations. The agreement has an initial five-year term with provision for annual extensions. VIRALEZE™ will be available in Vietnam to retail consumers, clinics, hospitals and pharmacies through the local medical distribution networks in Vietnam. [5]
In December 2021, Starpharma entered into a supply arrangement with Vietnam-based Truong Bao Land (TBL) responsible for importation and distribution of astodrimer (VIRALEZE™) antiviral nasal spray in Vietnam. The distribution agreement includes a minimum commitment of at least 1 million units of astodrimer in the first year with ongoing performance obligations. The agreement has an initial five-year term with provision for annual extensions. Starpharma will supply VIRALEZE™, with TBL and Nam Thanh Trade and Medical Services Company Limited (NTM) responsible for sales, distribution, and marketing of the product locally in Vietnam. VIRALEZE™ will be available in Vietnam to retail consumers, clinics, hospitals and pharmacies through the local medical distribution networks in Vietnam. [5]
In December 2021, Starpharma entered into a supply arrangement with Nam Thanh Trade and Medical Services Company (NTM) responsible for importation and distribution of astodrimer (VIRALEZE™) antiviral nasal spray in Vietnam. The distribution agreement includes a minimum commitment of at least 1 million units of astodrimer in the first year, with ongoing performance obligations. The agreement has an initial five-year term with provision for annual extensions. Starpharma will supply VIRALEZE™, Vietnam-based Truong Bao Land (TBL) and NTM will be responsible for sales, distribution, and marketing of the product locally in Vietnam. VIRALEZE™ will be available in Vietnam to retail consumers, clinics, hospitals and pharmacies through the local medical distribution networks in Vietnam. [5]
Starpharma, in Decemebr 2018 signed a licence agreement with ITF Pharma for the sales and marketing rights to VivaGel® BV in the United States for a term of 10 years or patent expiry (at least 2030 with potential extensions out to 2033) including customary provisions to extend the agreement. Under the licence, Starpharma is eligible to receive up to $US101M (A$142M) in regulatory approval and commercialisation milestones in addition to escalating double-digit royalties on sales. The milestones comprises $US20M (A$28M) in regulatory approval milestones for the two BV indications and up to $US81M (A$114M) in commercial milestones. Initially Starpharma will be responsible for supplying VivaGel® BV to ITF Pharma, however, in the future, Italfarmaco may also apply for FDA approval of its own manufacturing facility. Starpharma will responsible for regulatory activities for VivaGel® BV while ITF Pharma will be responsible for all commercialisation activities, including product launch, market pricing, reimbursement, marketing, promotion and sales. ITF Pharma will bear binding performance obligations including commitment to launch within a specified time frame and minimum annual purchases for the duration of the agreement as well as termination provisions under certain circumstances. [6]
In October 2017, Starpharma granted rights to Aspen Pharmacare for the marketing, promotion and local distribution of astodrimer for the treatment of bacterial vaginosis in Australia and New Zealand. Starpharma will supply Aspen with the product and will receive royalties on net sales. Further details of the agreement were not disclosed. [7]
In October 2006, Starpharma proposed to acquire Dendritic Nanotechnologies (DNT) for $US6.97 million. Under the acquisition, DNT, which had dendrimer IP and technology platform, became a wholly owned operating subsidiary of Starpharma [8] . Starpharma stated in its annual report for 2007 that the acquisition had been completed.
In March 2004, Starpharma Pooled Development changed its name to Starpharma [9] .
The Starpharma group acquired exclusive worldwide rights to the dendrimer and other polyvalent technologies of BRI.
In September 2003, Starpharma signed a clinical trial agreement with the Institute of Drug Technology Australia to conduct phase I clinical trials of astodrimer in Australia [10] .
Condom coating (not in development table)
In 2007, Starpharma entered two co-development license agreements relating to condom coating applications of astodrimer. One of the agreements was with SSL International plc (now Reckitt Benckiser), in which SSL was granted exclusive marketing rights to the astodrimer coated condom, and the other was with Okamoto Industries in China and Japan. The agreement with Reckitt Benckiser was terminated in August 2011, and in the same month, Starpharma signed an agreement granting Ansell Limited the marketing rights for the astodrimer-coated anti-viral condom, excluding Japan and some other Asian markets. Okamoto Industries continues to develop the product for the Japanese market. Starpharma will receive royalties and other payments from the agreements, and the condoms will carry the VivaGel® brand [11] [12] [13] .
Key Development Milestones
In July 2019, Starpharma reported that Mundipharma has made regulatory submissions in multiple countries for astodrimer, in accordance with the existing agreement between the two companies. Discussions related to prospective commercialisation in India, Canada and Israel were underway. Launch in multiple undisclosed countries as planned [14] .
In April 2019, Starpharma reported the conduction of a meeting with the US FDA, to elucidate and address the latter's request for confirmatory data prior to the approval of VivaGel® BV in the US. The company received formal feedback at this meeting, highlighting potential options. Earlier, the company had submitted a comprehensive package of information including additional statistical analyses of existing data on VivaGel® BV to the FDA, as a response to the FDA’s request, and to consolidate support for the approval of VivaGel® BV. In February 2019, the company was engaged with expert FDA consultants to expedite the process of providing confirmatory clinical data. Earlier, in December 2018, Starpharma reported that the US FDA required confirmatory clinical data prior to approving astodrimer (VivaGel® BV) for treatment of bacterial vaginosis (BV) and the prevention of recurrent BV [15] [16] . In July 2018, Starpharma's NDA, seeking approval for VivaGel® BV for the treatment and prevention of recurrent bacterial vaginosis, was accepted by the FDA for priority review. The FDA could not find issues, and completed the filing review [17] . In November 2017, Starpharma submitted the NDA. The submission was made through a rolling submission process, and was based on data from phase III trials in recurrent BV. The final module of the NDA was submitted in April 2018. Clinical section of the NDA was submitted in December 2017. The first three of five modules of the NDA were submitted in November 2017 [18] [19] [20] [21] .
Bacterial vaginosis (BV) - treatment
In November 2019, astodrimer was launched in the UK, under the brand name Betafem® BV gel [22] .
Starpharma reported in July 2019, that astodrimer was launched in Germany, under the brand name Betadine™ BV. This launch triggered a milestone payment of $US0.5 million to the company [14] .
In April 2019, Aspen Pharmacare launched astodrimer under the brand name Fleurstat™ BVgel for the treatment of bacterial vaginosis as an OTC product [23] . Earlier in October 2017, the Therapeutic Goods Administration of Australia approved astodrimer for the same indication [7] .
As of April 2020, astodrimer is available in New Zealand under the brand name Fleurstat™ BVgel [24] .
In August 2019, Starpharma received the regulatory approvals in South East Asia for astodrimer (VivaGel® BV) for the treatment of bacterial vaginosis (BV) and prevention of recurrent BV. The product will be available over-the-counter (OTC) under the brand name, BETADINETM BV gel in 2019 [25] .
In January 2017, the US FDA granted Qualified Infectious Disease Product (QIDP) designation and Fast Track designation to astodrimer for the treatment of bacterial vaginosis [26] .
In September 2015, Starpharma received marketing authorisation from the EC for astodrimer (VivaGel®BV) for the treatment of bacterial vaginosis. The approval allows marketing of the drug in all the 28 EU countries plus the EFTA countries [27] .
As of August 2015, Starpharma is engaged in commercial partnering discussions for astodrimer 1% gel for the symptomatic treatment of BV, in countries outside of the US. Regulatory dossiers are being prepared for several markets.
Starpharma completed two randomised, double-blind, placebo-controlled, pivotal phase III trials of astodrimer 1% gel for the symptomatic treatment of BV in December 2012 (NCT01577537 and NCT01577238). The trials began in March 2012 and enrolled 251 and 250 participants, respectively. Study participants were aged 12 years or older; both trials were conducted in the US, and NCT01577537 also included trial sites in Belgium and Germany. Treatment was administered at bedtime for 7 consecutive days, and the primary endpoint was the number of patients with clinical cure at the test of cure visit (days 21 to 30 after the last dose) [28] [29] . By early June 2012, both trials had reached 60% of their targeted enrolment and by late June, enrolment had been completed for the first of two trials. The second trial had enrolled more than 70% of patients as of July 2012 [30] [31] [32] . These trials were conducted under the FDA's Special Protocol Assessment (SPA) scheme [33] [34] [35] .
Late in 2011, Starpharma reached an agreement with the EMA regarding the proposed design of phase III trials to support the approval of astodrimer for the treatment of BV [36] .
In May 2011, Starpharma completed a dose-ranging, double-blind, randomised, placebo-controlled phase II trial of astodrimer gel for the treatment of BV (NCT01201057). The trial enrolled 132 patients in the US, and assessed doses of 0.5, 1.0 and 3.0% [37] . The trial met its primary endpoint of the number of patients with clinical cure over days 21 to 30 [11] [38] .
Bacterial vaginosis (BV) - prevention
In January 2017, the US FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designation to astodrimer for the prevention of bacterial vaginosis [26] .
In March 2017, Starpharma completed a phase III trial that evaluated the efficacy and safety of astodrimer gel for the prevention of recurrent bacterial vaginosis (NCT02236156; UKCRN17537; REPR3661; SPL7013-018; EudraCT2014-000694-39). The double-blind, parallel, prospective, randomised trial was initiated in September 2014 and enrolled 637 patients in the US, Bulgaria, Czech Republic, Hungary, Ukraine, the UK [39] . In March 2017, Starpharma completed another phase III trial that evaluated the efficacy and safety of astodrimer gel for the prevention of recurrent bacterial vaginosis (NCT02237950; SPL7013-017). The double-blind, parallel, prospective, randomised trial was initiated in September 2014 and enrolled 586 patients in the US, Canada and Puerto Rico [40] . In July 2014, the US FDA granted a Special Protocol Assessment (SPA) agreement for the study design and planned analysis of the phase III trials. Starpharma had previously reached an agreement with the EMA on the design of the studies [41] . In August 2017, the company released individual results as well as combined from the two phase III trials showing statistically significant differences between the rates of BV recurrence in the astodrimer group versus placebo (017 US trial plus 018 European trial full analysis P = 0.002, 017 US trial plus 018 European trial additional analysis P = 0.014) [21] .
Starpharma completed its phase II trial of astodrimer for the prevention of BV in December 2012 (NCT01437722). The US-based, randomised, double-blind, placebo-controlled, 16-week trial investigated the efficacy and tolerability of two concentrations of astodrimer (1% and 3% gel) to prevent recurrence of the disease in women with a history of recurrent BV. The agent was administered every second day for 16 weeks, with an 8-week follow-up period. In total, 205 participants were enrolled [31] [11] [42] [30] . Results demonstrated that more than 80% of women treated with the 1% formulation product remained disease-free at 16 weeks. In addition, the drug protected against occurrence of symptoms of bacterial vaginosis [41] .
COVID-2019 infections
In November 2022, astodrimer (VIRALEZE™) antiviral nasal spray was launched in Hong Kong and Macau for the treatment of COVID-2019 infections [43] .
As of January 2023, astodrimer nasal spray has been launched in Italy [44] .
In December 2021, Starpharma announced that, astodrimer (VIRALEZE™) as an antiviral nasal spray has successfully launched in Vietnam for the treatment of COVID-2019 infections. Earlier VIRALEZE™ antiviral nasal spray has been registered for sale in Vietnam [45] [5] [46] .
Prior to June 2021, Astodrimer registered and launched in the United kingdom and India [47] .
In June 2023, Starpharma received regulatory approval for its antiviral nasal spray product, VIRALEZE™, in Malaysia [48] .
In December 2022, astodrimer nasal spray was approved for marketing authorisation in Indonesia [49] .
In December 2020, Starpharma had received all necessary approvals to commence its clinical study for astodrimer nasal spray. This study will support commercialisation activities of the candidate and is not a requirement to achieve EU product registration [50] .
In March 2021, Starpharma completed a phase I trial that assessed the safety and tolerability of astodrimer nasal spray applied to the nasal mucosa of healthy volunteers 4 times a day for 14 days (381040; SPL7013-021; ACTRN12620001371987). The double-blind, randomised trial was initiated in January 2021 and enrolled 40 participants in Australia [51] .
In January 2023, pharmacodynamics data from a preclinical study in COVID-2019 infections released by Starpharma [52]
In July 2022, pharmacodynamics data from a preclinical studies in COVID-2019 infections released by Starpharma [52]
In August 2021, Starpharma released the data demonstrating protective efficacy of astodimer antiviral nasal spray against SARS-CoV-2 challenge in vivo in a humanised mouse model of coronavirus infection. In contrast to control animals no infectious virus was detected in brain and liver of astodimer treated animals. Viral load (amount of virus) in the nasal cavity of animals treated with astodimer was also significantly lower (>90%) compared with the control animals. Reduction in the pro-inflammatory cytokines (“cytokine storm”) in response to SARS-CoV-2 challenge after SARS-CoV-2 infection was observed when treated with astodimer as compared to control animals also there was reduction in the infectious SARS-CoV-2, Delta variant by >99.9% within 30 seconds of exposure. Astodrimer administered nasally reduced viral load by more than 99.9% in the lungs and trachea of animals challenged with the SARS-CoV-2 virus, compared to saline-control [53] .
In June 2021, Starpharma reported that the preclinical studies of astodrimer against the Japan/Brazil and South Africa variants is underway. The India (B.1.617.2) variant, which is currently linked to outbreaks in the UK and Australia, is planned to be tested when virus availability permits [54] .
In June 2021, Starpharma and the Scripps Research Institute released preclinical data of astodrimer against COVID-2019 infections [54] [55] .
In preclinical studies, astodrimer stopped infection when applied to cells before or after exposure to the virus [50] .
In August 2020, Starpharma released preclinical data of astodrimer nasal spray against COVID-2019 infections [56] . The therapy has demonstrated antiviral efficacy against different isolates of SARS-CoV2, including those from Australia, Europe and the US [57] .
In April 2020, Starpharma conducted preclinical studies for astodrimer (SPL 7013) for COVID-2019 infections demonstrating significant antiviral activity against the coronavirus. SPL 7013 inhibited the infection of cells with the SARS-CoV-2 virus [58] [59] . Starpharma plans for additional short term preclinical trials for the treatment of COVID-19 infections. In September 2020, Starpharma released additional data from preclinical studies which confirm the potent antiviral activity of astodrimer nasal spray, when used before or after exposure of cells to SARS-CoV-2 virus [60] [59] . In August 2021, Starpharma released data demonstrating protective effects of astodrimer in this SARS-CoV-2 animal model which were consistent with the previously reported virucidal activity of SPL 7013. The antiviral agent in astodrimer, has previously been shown in vitro to have potent antiviral and virucidal activity in multiple variants of SARS-CoV-2, including inactivation of >99.9% of the delta variant [61] .
HIV infections, Genital herpes (herpes simplex virus infections) and human papillomavirus (HPV) infections: As of August 2015, astodrimer gel is still in clinical development for the prevention of HIV infections and genital herpes.
In January 2006, Starpharma received fast track status from the US FDA for astodrimer in the prevention of HIV [62] .
A phase I/II trial assessed the retention and anti-viral activity of astodrimer 3% gel in 12 volunteers in Australia (NCT00740584). The trial was completed in March 2009.
A phase I trial, funded by NIAID, began in October 2006 and evaluated the safety of astodrimer 3% in 60 healthy young women (18-24 years), 30 from the US and 30 from Kenya (NCT00331032). Volunteers applied astodrimer vaginally twice daily for 2 weeks and safety was assessed via clinical symptoms, pelvic examinations, and a standardised questionnaire [63] . Results showed the product to be safe and well tolerated. This was the first study to be conducted under the IND filed with the US FDA for 3% astodrimer gel for the prevention of genital herpes [64] [65] .
Starpharma, in collaboration with the National Institutes of Allergy and Infectious Diseases (NIAID) and the Adolescent Medicine Trials Network for HIV/AIDS Interventions, conducted a randomised, double-blind, placebo-controlled phase I trial safety and acceptability trial of astodrimer 3% in healthy, sexually active female volunteers aged 18-24 (NCT00442910). The trial enrolled 61 subjects in the US and Puerto Rico [66] . Results have been reported [67] .
A phase I trial conducted in Australia by Starpharma showed that astodrimer gel (0.5-3%) was safe and well tolerated in healthy male volunteers (NCT00370357) [68] [69] .
Starpharma was awarded a $US20.3 million grant by the NIAID in the US in October 2005, for the development of astodrimer [70] .
In July 2003, the US FDA cleared an Investigational New Drug Application (IND) filed by StarPharma for astodrimer in HIV infections [71] .
Starpharma initiated early research in 2014 to investigate astodrimer gel for the prevention of HPV transmission.
Other viral infections
Starpharma, in March 2021, reported that according to studies at the Scripps Research Institute, astodrimer was found to exert antiviral activity against the severe acute respiratory syndrome (SARS) coronavirus and Middle East respiratory syndrome (MERS) coronavirus, with activity also demonstrated in a further European isolate of SARS-CoV-2 and the influenza virus subtype H3N2. The candidate exerted its action through blockade of the spike proteins of the SARS and NERS causing coronaviruses [57] .
Zika virus infections
In May 2016, Starpharma announced that astrodimer showed potent anti-viral activity against Zika virus in laboratory studies [72] .
Viral conjunctivitis
SPL 7013 ophthalmic drops have demonstrated compelling efficacy in animal models of viral conjunctivitis. The drops have shown potent anti-viral activity, decreased infectivity and importantly, they are non-irritating [73] .
Condom coating (not in development table)
Starpharma has developed an antiviral condom which uses VivaGel® in the lubricant, which is available in Australia and Canada under the Lifestyles® Dual Protect™ brand and is also launched in Japan. Starpharma has multiple license agreements to market the VivaGel® condom in other regions, including China and Japan with Okamoto Industries [14] [74] [75] .
Financing information
In September 2020, Starpharma received a award of $US1 million in matched funding from the Australian Government’s Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) Program for the development and commercialisation of its COVID‑19 antiviral nasal spray SPL 7013 [76] .
Starpharma announced a successful capital raising of $A15.6 million in November 2009, which will be used primarily for the development of astodrimer through to completion of phase III trials for the treatment of BV [77] .
Patent Information
In April 2020, Starpharma announced that it has filed a new patent based on laboratory studies of SPL 7013 and its significant antiviral activity against the coronavirus that causes COVID-19 (coronavirus disease)in unknown territory [59] .
In December 2018, Starpharma announced that the US Patent and Trademark Office has granted a patent for SPL 7013 ophthalmic drops for viral conjunctivitis. The patent covers broad claims for treating and preventing microbial infections of the eye, including adenoviral conjunctivitis, bacterial conjunctivitis and other eye infections. The patent is valid through 2033 [73]
Starpharma filed a patent for astodrimer in the treatment of bacterial vaginosis, based on results from a phase II study (NCT01201057). This patent will expand and extend the protection for astodrimer to at least 2032 [38] .
Starpharma was granted a 5-year extension to an existing US patent covering astodrimer. The patent is due to expire in 2024, but a further 12-month extension until 2025 is possible [12] .
In October 2008, Starpharma was granted a key patent covering astodrimer and astodrimer-coated condoms in Japan to protect against sexually transmitted infections. Astodrimer and its related condom application are covered by patents in all major markets including Europe and the US [78] . In August 2010, Starpharma was granted the first patent to specifically cover the astodrimer-coated condom, in Russia. This patent is valid until 2026. The company has also filed this patent in the US, Canada, Europe, Japan, China and India.
Starpharma was issued a patent titled "Antiviral Dendrimers" by the US patent office in February 2001 to cover the use of dendrimers as antiviral pharmaceuticals.
Drug Properties & Chemical Synopsis
- Route of administration Intranasal, Ophthalmic, Topical, Vaginal
- Formulation Drops, Gel, Spray, unspecified
- Class Antibacterials, Antivirals, Dendrimers, Peptides
- Target Anion transport protein; Surface antigen
- Mechanism of Action Anion transport protein modulators; Surface antigen modulators
-
WHO ATC code
D06A (Antibiotics for Topical Use)
D06B-B (Antivirals)
G02B (Contraceptives for Topical Use)
J05 (Antivirals for Systemic Use)
J05A-X (Other antivirals)
S01A-D (Antivirals)
-
EPhMRA code
D6A (Topical Antibacterials)
D6D (Topical Viral Infection Products)
G2B (Topical Contraceptives)
J5 (Antivirals for Systemic Use)
J5B9 (Antivirals, others)
- Chemical name N2,N6-bis{N2,N6-bis[N2,N6-bis(N2,N6-bis{N2,N6-bis[(3,6-disulfonaphthalen-1-yloxy)acetyl]-l-lysyl}-l-lysyl)-l-lysyl]-l-lysyl}-N1-(diphenylmethyl)-l-lysinamide
- Molecular formula C583 H641 N63 O287 S64
- CAS Registry Number 1379746-42-5
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
herpes genitalis |
Detailed Description |
SYTL1 SUN domain containing ossification factor SLPI SERPINA13P PSA CXCR4 C-C chemokine receptor type 5 (CCR5) |
|
|
herpes genitalis |
Outcome Measure |
SERPINA13P CXCR4 C-C chemokine receptor type 5 (CCR5) |
|
|
herpes simplex virus infections |
Detailed Description |
SYTL1 SUN domain containing ossification factor SLPI SERPINA13P PSA CXCR4 C-C chemokine receptor type 5 (CCR5) |
|
|
herpes simplex virus infections |
Outcome Measure |
SERPINA13P CXCR4 C-C chemokine receptor type 5 (CCR5) |
|
|
HIV infections |
Detailed Description |
SYTL1 SUN domain containing ossification factor SLPI SERPINA13P PSA CXCR4 C-C chemokine receptor type 5 (CCR5) |
|
|
HIV infections |
Outcome Measure |
SERPINA13P CXCR4 C-C chemokine receptor type 5 (CCR5) |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Astodrimer - Starpharma | C-C chemokine receptor type 5 (CCR5) | Detailed Description, Outcome Measure |
| CXCR4 | Detailed Description, Outcome Measure | |
| PSA | Detailed Description | |
| SERPINA13P | Detailed Description, Outcome Measure | |
| SLPI | Detailed Description | |
| SUN domain containing ossification factor | Detailed Description | |
| SYTL1 | Detailed Description |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Bacterial vaginosis | - | - | Marketed | Australia, Germany | Vaginal / Gel | Starpharma | 16 Jul 2019 |
| Bacterial vaginosis | - | Prevention | Marketed | United Kingdom | Vaginal / Gel | Starpharma | 31 Jan 2020 |
| Bacterial vaginosis | - | - | Marketed | New Zealand | Vaginal / Gel | Aspen Pharmacare | 07 Apr 2020 |
| Bacterial vaginosis | - | - | Registered | European Union, Iceland, Liechtenstein, Norway | Vaginal / Gel | Starpharma | 24 Sep 2015 |
| Bacterial vaginosis | - | Recurrent | Preregistration | USA (fast track) | Vaginal / Gel | Starpharma | 21 Nov 2017 |
| Bacterial vaginosis | - | Prevention, Recurrent | Preregistration | USA (fast track) | Vaginal / Gel | Starpharma | 21 Nov 2017 |
| Bacterial vaginosis | - | Prevention | Phase III | Bulgaria, Canada, Czech Republic, Hungary, Mexico, Puerto Rico, Thailand, Ukraine | Vaginal / Gel | Starpharma | 07 Aug 2017 |
| COVID 2019 infections | - | - | Marketed | United Kingdom | Intranasal / Spray | Starpharma, The Scripps Research Institute | 12 Jun 2021 |
| COVID 2019 infections | - | - | Marketed | Hong Kong, India, Italy, Macau, Vietnam | Intranasal / Spray | Starpharma | 21 Nov 2022 |
| COVID 2019 infections | - | - | Registered | Indonesia, Malaysia | Intranasal / Spray | Starpharma | 05 Jun 2023 |
| COVID 2019 infections | - | In volunteers, Prevention | No development reported (I) | Australia | Intranasal / Spray | Starpharma | 28 Feb 2024 |
| Conjunctivitis | - | - | No development reported (Preclinical) | Australia | Ophthalmic / Drops | Starpharma | 28 Jan 2023 |
| HIV infections | - | In volunteers, Prevention | Phase I/II | Australia | Vaginal / Gel | Starpharma | 31 Aug 2008 |
| HIV infections | - | Prevention | No development reported (I) | Puerto Rico, USA (fast track) | Vaginal / Gel | Starpharma | 04 Nov 2017 |
| Herpes simplex virus infections | - | In volunteers, Prevention | Phase I/II | Australia | Vaginal / Gel | Starpharma | 31 Aug 2008 |
| Herpes simplex virus infections | - | In volunteers, Prevention | No development reported (I) | Kenya, Puerto Rico, USA | Vaginal / Gel | Starpharma | 04 Nov 2017 |
| Human papillomavirus infections | - | Prevention | No development reported (Research) | Australia | Vaginal / Gel | Starpharma | 28 Jan 2019 |
| Influenza A virus H1N1 subtype | - | - | Preclinical | Australia | Intranasal / Spray | Starpharma | 25 Feb 2021 |
| Influenza A virus H3N2 subtype | - | - | Preclinical | USA | Intranasal / Spray | Starpharma, The Scripps Research Institute | 03 Mar 2021 |
| Middle East respiratory syndrome coronavirus | - | - | Preclinical | USA | Intranasal / Spray | Starpharma, The Scripps Research Institute | 03 Mar 2021 |
| Respiratory syncytial virus infections | - | - | Preclinical | Australia | Intranasal / Spray | Starpharma | 25 Feb 2021 |
| Severe acute respiratory syndrome | due to coronaviruses | - | Preclinical | USA | Intranasal / Spray | Starpharma, The Scripps Research Institute | 03 Mar 2021 |
| Zika virus infection | - | - | No development reported (Research) | Australia | unspecified / unspecified | Starpharma | 28 Jun 2020 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Fast Track | USA | Bacterial vaginosis; HIV infections |
| Qualified Infectious Disease Product | USA | Bacterial vaginosis; Bacterial vaginosis |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Biomolecular Research Institute | Originator | USA |
| Biomolecular Research Institute | Owner | USA |
| ITF Pharma | Market Licensee | USA |
| Hengan Group | Market Licensee | Hong Kong, Macau |
| Aspen Pharmacare | Market Licensee | Australia, New Zealand |
| Starpharma | Licensee | World |
| Mundipharma International | Sub-licensee | Africa, Asia, Commonwealth of Independent States, European Union, Latin America, Middle East |
| The Scripps Research Institute | Collaborator | USA |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| Starpharma | - | Unspecified | North America | 09 Jul 2018 |
Brand Names
| Brand Name | Organisations | Indications | Countries |
|---|---|---|---|
| BETADINE BV Gel | Mundipharma International | Bacterial vaginosis | Asia |
| Betadine BV | Mundipharma International | Bacterial vaginosis | Germany |
| Betafem BV | Starpharma | Bacterial vaginosis | United Kingdom |
| Fleurstat BVgel | Aspen Pharmacare, Apsen Farmaceutica | Bacterial vaginosis | Australia, New Zealand |
| VIRALEZE | Starpharma | COVID 2019 infections | Hong Kong, Vietnam, Italy, Macau, Indonesia |
| Viraleze | Starpharma | COVID 2019 infections | Europe, United Kingdom |
| VivaGel | Starpharma | Bacterial vaginosis, Herpes simplex virus infections, HIV infections | World |
Scientific Summary
-
Adverse Events
Occasional:
Genitourinary disorders; Headache
Pharmacokinetics
In two phase I trials, astodrimer was not detected in plasma after topical administration. In one phase I trial, 30 healthy females applied astodrimer gel (0.5-3%) vaginally. In the second phase I trial, 36 healthy male volunteers applied astodrimer gel (3%) onto the penis once a day for 7 days [68] [69] .
Adverse Events
Phase II
Astodrimer had an adverse event profile similar to that of placebo in women with bacterial vaginosis in a phase II study (NCT01201057). No grade 3 adverse events were reported. In this trial, patients received VivaGel® containing astodrimer 0.5-3% once daily for 7 days [38] .
Phase I
Astodrimer was safe and well tolerated in a phase I trial in 36 circumcised and uncircumcised healthy male volunteers (21-67 years). Subjects applied 3% astodrimer gel 2g (n = 24) or placebo (n = 12) to the penis once daily for 7 days. Genital adverse events (AEs) reported during the study were mild in severity and most lasted for <24h. Such AEs were reported in 33% of both the active and placebo arms and the most common genital AEs reported were genital pruritus (12% of active group and 8% of placebo group) and application site erythema (4% and 25%). There was no evidence of systemic toxicity during the trial and of the 32 non-genital AEs reported, 16 could have been related to the study drug; 6 AEs were reported by 25% of the active group and 10 AEs were reported by 33% of the placebo group. The most common, non-genital AE was headache and was reported in 13% and 25% of the active and placebo arms, respectively [68] [84] .
A phase I trial of astodrimer gel showed the compound was safe and well tolerated. Thirty healthy adult females applied astodrimer gel (0.5-3%) intravaginally once daily for seven consecutive days. No serious adverse events were reported. In the placebo group, one volunteer experienced a severe tension headache and one had a moderate skin rash. All other adverse events potentially related to the study treatment were mild and included abdominal discomfort or pain (4 in active arm, 1 in placebo arm), dysuria (1 in active group), and genital pruritis (1 in placebo group). Furthermore, there were no clinically significant findings or changes in the vagina, cervix or external genitalia of any women receiving placebo or active gels [69] .
Data from a clinical trial involving 54 sexually abstinent women from the US and Kenya have shown that 3% gel formulation of astodrimer (VivaGel®) was safe and well tolerated. The gel was administered vaginally, twice daily for 14 days. There was no significant difference between the treatment groups in the number of women who experienced any sign or symptom (including genitourinary signs/symptoms) deemed to be associated with astodrimer. The incidence of these genital signs and symptoms reported with astodrimer in the study was in line with that reported with other topical vaginal products, and markedly lower that that reported with nonoxynol-9 in similar studies [80] .
Pharmacodynamics
Summary
HSV-2 infection Preclinical studies
astodrimer (15µL of 100 mg/mL solution) provided significant protection against herpes simplex virus-2 (HSV-2) infection when administered intravaginally 20 seconds prior to HSV-2 challenge. No signs of infection or disease were observed in any of the mice in this treatment group. Astodrimer remained effective when the concentration of the solution was reduced to 10 mg/mL and 1 mg/mL with 10/12 (83%) and 6/12 (50%) mice remaining uninfected, respectively. In comparison, all mice in the control group tested positive for HSV-2 infection [83] .
In both mouse and guinea-pig models of genital HSV-2, pretreatment intravaginally with astodrimer (1% gel formulation) protected against disease and infection. Significant protection against disease and infection, respectively, was achieved at 5 min (53% and 53%), 30 min (60% and 53%) and 60 min (40% and 40%) compared with placebo. In guinea-pig model of genital HSV-2, astodrimer (5% formulation) protected against infection and disease by 73% and 80%, respectively. There was an overall concentration effect seen for the protection against both infection and disease [81] .
In SARS-CoV and MERS-CoV assays, SPL 7013 resulted in approximately 80% reduction in infected cells for SARS-CoV, MERS-CoV or SARS-CoV-2 expressing lentiviruses (30 mg/mL), versus infection in cells without SPL 7013. In addition, level of inhibition for the SARS‑CoV- and MERS-CoV-expressing lentiviruses was comparable to that observed for those expressing the SARS-CoV-2 spike protein. SPL7013 blocked the binding of the spike proteins at concentrations that demonstrated potency against SARS‑CoV‑2 spike protein binding and infection [57] .
COVID-2019 infections
In preclinical study, astodrimer demonstrated potent antiviral activity and high selectivity index against SARS-CoV-2. Astodrimer inhibited SARS-CoV2 infection in host cells. Selectivity index assays demonstrated high index for astodrimer of up to ~2200 as compared with 279 for remdesivir and 172 for chloroquine, implying potent antiviral efficacy and minimum cellular toxicity. In virucidal activity assay, addition of astodrimer to SARS-CoV-2 before adding the virus to cells led to inactivation of 99.9% of viral load and prevented viral infection in cells [60] [56] . In another study, SPL 7013 resulted in no detectable binding of the SARS-CoV-2 spike protein to the cells expressing the hACE2 receptor [57] .
In preclinical studies, astodrimer nasal spray was active against the highly infectious UK variant of SARS-CoV-2, by reducing infectivity of the virus by >98%. There was no loss of potency, when compared with an earlier US strain of the virus, which was irreversibly inactivated by astodrimer within one minute of exposure. Astodrimer consistently showed high levels of antiviral activity, not only against multiple COVID-2019 strains, but also against a broad spectrum of other respiratory viruses including influenza. Moreover, in preclinical studies, astodrimer nasal spray potent antiviral activity against the Europe (Slovakia/SK‑BMC5/2020), and Australia (hCoV-19/Australia/VIC01/2020) variant of SARS-CoV-2 [54] [55] .
Data from the preclinical studies, demonstrated the capability of astodrimer antiviral nasal spray to protect against SARS-CoV-2 in an animal challenge model of SARS-CoV-2 infection. Astodrimer administered nasally reduced viral load by more than 99.9% in the lungs and trachea of animals challenged with the SARS-CoV-2 virus, compared to saline-control. The impressive protective effects of astodrimer in this SARS-CoV-2 animal model were consistent with the previously reported virucidal activity of astodrimer demonstrating potent antiviral activity in multiple respiratory viruses and multiple variants of SARS-CoV-2. The study used the K18-hACE2 mouse model, an in vivo humanised mouse model that expresses the human angiotensin converting enzyme (hACE2) receptor, the receptor used by SARS-CoV-2 to infect cells in the human nasal cavity and respiratory tract [61] . Reduction in the pro-inflammatory cytokines (“cytokine storm”) in response to SARS-CoV-2 challenge after SARS-CoV-2 infection was observed when treated with astodimer as compared to control animals also there was reduction in the infectious SARS-CoV-2, Delta variant by >99.9% within 30 seconds of exposure [53] .
Results from preclinical studies showed protection against infection with the highly transmissible SARS-CoV-2 Omicron variant in a stringent viral challenge model of K18-hACE2 mouse. Treatment of animals with VIRALEZE™ pre- and post-infection markedly reduced SARS-CoV-2 Omicron viral load in the lungs, trachea, and nasal cavity compared with PBS. Animals treated with VIRALEZE™ post-infection had only very low detectable virus on Day 2, which remained at a relatively low level on Days 4 and 7. The level of pro-inflammatory cytokines in blood was correlated with the level of virus in the lung, trachea, nasal cavity and blood. Pro-inflammatory cytokines were, therefore, reduced in animals treated with VIRALEZE™ (both treatment strategies) compared to animals treated with PBS [52]
In preclinical studies, involving astodrimer nasal spray against SARS-CoV-2 Omicron infection in an animal challenge model, the candidate eliminated SARS-CoV-2 Omicron virus (≥99.99% reduction in viral load compared with saline-treated animals) in the lung and trachea of virus-challenged animals, even when it was administered only after animals were exposed to virus. The astodrimer-treated animals also exhibited significantly reduced proinflammatory cytokines compared with saline-treated animals; and achieved normal body weight gain compared to significant weight loss observed in saline-treated animals [44]
Antimicrobial Activity
Summary
Astodrimer has an EC50 of 0.6 µg/mL against herpes simplex virus-2 (HSV-2) when applied to cell monolayers 1h prior to addition of virus. It was less effective in cells already infected with the virus (EC50 = 3.6 µg/mL). Astodrimer was also active against HSV-1, with EC50 values of 0.9 µg/mL in pretreated cells and 4.6 µg/mL when administered post-inoculation. Astodrimer was non-cytotoxic (CC50 > 1 mg/mL), giving the compound a high selectivity index [83] .
Therapeutic Trials
VivaGel® (containing 1% active SPL 7013) once daily for 7 days was effective in women with bacterial vaginosis in a phase II study (NCT01201057). The proportion of patients achieving clinical cure rate, compared with placebo, was 74% versus 22% (p=0.0002) at 2-5 days after completion of therapy, and 46% vs 12% (p=0.006) at 2-3 weeks after completion of therapy (primary endpoint). More patients in the active treatment group were extremely satisfied, very satisfied or satisfied, compared with the placebo group (83% vs 35%) [38] .
Results from the two phase III 017 US and 018 European trials showed that in both the studies, women remained BV-recurrence-free during the 16-week treatment phase. In the 017 US trial, the rate of bacterial vaginosis (BV) recurrence at or by week 16 ( the primary endpoint) in the astodimer group was 44.2% (statistically significant vs. placebo 54.3%, P=0.015, N = 585). Actual BV recurrence rate were even lower at 34.9% for astodrimer and 46.6% for placebo. The 16-week Historical Recurrence Rate for the trial participants in the 017 US trial was approximately 65%. In the 018 European trial, the rate of BV recurrence at or by week 16 in the drug group was just 15.7% (statistically significant vs. placebo 22.6%, P=0.027, N = 636). In comparison, the 16-week Historical Recurrence Rate (without intervention) for the 018 European trial participants was approximately 50% [21] [82] [39] [40] .
Results from a phase I study of topical astodrimer in healthy women demonstrated anti-HIV and HSV-2 activity following administration. Cervicovaginal fluid samples (CVS) taken from healthy women immediately, then at 1, 3, 12 and 24 hours after separate vaginal doses of the product. Samples were tested for their ability to prevent HIV and HSV-2 infection of susceptible cells in vitro. CVS obtained immediately after vaginal administration of topical astodrimer provided complete inhibition of HIV and HSV infection. At 1 and 3 hours following administration, the initial high level of inhibition of HIV and HSV was retained in all women tested. At 12 and 24 hours following administration, more than 90% of the initial antiviral activity was retained for both HIV and HSV in more than half of the women in the study [67] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2021 | Regulatory Status | Starpharma intends to launch Astodrimer for COVID-2019 infections (Spray) in Vietnam [46] | 14 Dec 2021 |
| 30 Apr 2021 | Regulatory Status | Starpharma intends to launch Astodrimer for COVID-2019 infections (Spray) in United Kingdom in April 2021 [79] | 03 Jun 2021 |
| 05 Jan 2021 | Trial Update | Starpharma plans a phase I trial for COVID-2019 infection (In volunteers) in Australia (Intranasal), in January 2021 (ACTRN12620001371987) | 20 Jul 2021 |
| 30 Mar 2019 | Regulatory Status | Aspen Pharmacare intends to launch Astodrimer for Bacterial vaginosis in Australia in the first half of 2019 [16] | 22 Apr 2019 |
| 02 Jan 2019 | Regulatory Status | MundiPharma intends to launch astodrimer for Bacterial vaginosis in Europe in the first half of 2019 [16] | 02 Jan 2019 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Feb 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(Prevention, In volunteers) in Australia (Intranasal, Spray) Updated 28 Feb 2024 |
| 12 Jun 2023 | Regulatory Status | Starpharma plans to launch astodrimer for Covid-2019 infection in Malaysia [48] Updated 14 Jun 2023 |
| 05 Jun 2023 | Phase Change - Registered | Registered for COVID-2019 infections in Malaysia (Intranasal) [48] Updated 14 Jun 2023 |
| 30 Jan 2023 | Phase Change - Marketed | Launched for COVID-2019 infections in Italy (Intranasal) prior to January 2023 [44] Updated 02 Feb 2023 |
| 30 Jan 2023 | Scientific Update | Pharmacodynamics data from a preclinical study in COVID-2019 infections released by Starpharma [44] Updated 02 Feb 2023 |
| 28 Jan 2023 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Conjunctivitis in Australia (Ophthalmic, Drops) Updated 28 Jan 2023 |
| 14 Dec 2022 | Phase Change - Registered | Registered for COVID-2019 infections in Indonesia (Intranasal) [49] Updated 02 Feb 2023 |
| 21 Nov 2022 | Phase Change - Marketed | Launched for COVID-2019 infections in Hong Kong (Intranasal) [44] Updated 02 Feb 2023 |
| 21 Nov 2022 | Phase Change - Marketed | Launched for COVID-2019 infections in Macau (Intranasal) [44] Updated 02 Feb 2023 |
| 21 Oct 2022 | Licensing Status | Hengan Group enters into a marketing and distribution agreement with Starpharma for astodrimer [4] Updated 02 Feb 2023 |
| 20 Jul 2022 | Scientific Update | Pharmacodynamics data from a preclinical studies inCOVID-2019 infections released by Starpharma [52] Updated 22 Jul 2022 |
| 31 Dec 2021 | Regulatory Status | Starpharma anticipates launch of Astodrimer in COVID-2019 infections in Italy by December 2021 Updated 07 Jan 2022 |
| 03 Dec 2021 | Phase Change - Marketed | Launched for COVID-2019 infections in Vietnam (Intranasal) [5] [45] Updated 14 Dec 2021 |
| 01 Dec 2021 | Regulatory Status | Starpharma intends to launch Astodrimer for COVID-2019 infections (Spray) in Vietnam [46] Updated 14 Dec 2021 |
| 01 Dec 2021 | Phase Change - Registered | Registered for COVID-2019 infections in Vietnam (Intranasal) [46] Updated 13 Dec 2021 |
| 23 Aug 2021 | Scientific Update | Pharmacodynamics data from the preclinical studies in COVID-19 infections released by Starpharma [61] Updated 25 Aug 2021 |
| 23 Aug 2021 | Scientific Update | Pharmacodynamics data from the preclinical studies in COVID-19 infections released by Starpharma [53] Updated 25 Aug 2021 |
| 12 Jun 2021 | Phase Change - Marketed | Launched for COVID-2019 infections in India (Intranasal) before June 2021 [47] Updated 18 Jun 2021 |
| 12 Jun 2021 | Phase Change - Marketed | Launched for COVID-2019 infections in United Kingdom (Intranasal) before June 2021 [47] Updated 18 Jun 2021 |
| 11 Jun 2021 | Phase Change - Registered | Registered for COVID-2019 infections in India (Intranasal) before June 2021 [47] Updated 18 Jun 2021 |
| 11 Jun 2021 | Phase Change - Registered | Registered for COVID-2019 infections in United Kingdom (Intranasal) before June 2021 [47] Updated 18 Jun 2021 |
| 01 Jun 2021 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in United Kingdom (Intranasal) before June 2021 [55] Updated 03 Jun 2021 |
| 01 Jun 2021 | Scientific Update | Pharmacodynamics data from a preclinical trial in COVID-2019 infection released by Starpharma and the Scripps Research Institute [55] [54] Updated 03 Jun 2021 |
| 29 Mar 2021 | Trial Update | Starpharma completes a phase I trial in COVID-2019 infections (Prevention, In volunteers) in Australia (Intranasal) (ACTRN12620001371987) Updated 20 Jul 2021 |
| 25 Mar 2021 | Regulatory Status | Starpharma intends to launch Astodrimer for COVID-2019 infections (Spray) in United Kingdom in April 2021 [79] Updated 03 Jun 2021 |
| 03 Mar 2021 | Phase Change - Preclinical | Preclinical trials in Influenza A virus H3N2 subtype in USA (Intranasal) [57] Updated 08 Mar 2021 |
| 03 Mar 2021 | Phase Change - Preclinical | Preclinical trials in Middle East respiratory syndrome coronavirus in USA (Intranasal) [57] Updated 08 Mar 2021 |
| 03 Mar 2021 | Phase Change - Preclinical | Preclinical trials in Severe acute respiratory syndrome in USA (Intranasal) [57] Updated 08 Mar 2021 |
| 03 Mar 2021 | Scientific Update | Pharmacodynamics data from studies in Severe acute respiratory syndrome coronavirus, Middle East respiratory syndrome coronavirus and SARS-CoV-2 infections released by Starpharma [57] Updated 08 Mar 2021 |
| 25 Feb 2021 | Phase Change - Preclinical | Preclinical trials in Respiratory syncytial virus infections in Australia (Intranasal) before February 2021 Updated 01 Mar 2021 |
| 25 Feb 2021 | Phase Change - Preclinical | Preclinical trials in Influenza A virus H1N1 subtype in Australia (Intranasal) before February 2021 Updated 01 Mar 2021 |
| 06 Jan 2021 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (Prevention, In volunteers) in Australia (Intranasal) (ACTRN12620001371987) Updated 20 Jul 2021 |
| 22 Dec 2020 | Trial Update | Starpharma plans a phase I trial for COVID-2019 infection (In volunteers) in Australia (Intranasal), in January 2021 (ACTRN12620001371987) Updated 20 Jul 2021 |
| 22 Dec 2020 | Regulatory Status | Starpharma receives approval to commence a clinical trial in COVID-2019 infections in Australia [50] Updated 23 Dec 2020 |
| 14 Sep 2020 | Scientific Update | Preclinical pharmacodynamics data in COVID-2019 infections released by Starpharma [60] Updated 15 Sep 2020 |
| 25 Aug 2020 | Scientific Update | Preclinical pharmacodynamics data in COVID-2019 infections released by Starpharma [56] Updated 27 Aug 2020 |
| 28 Jun 2020 | Phase Change - No development reported | No recent reports of development identified for research development in Zika-virus-infection in Australia Updated 28 Jun 2020 |
| 17 Apr 2020 | Patent Information | Starpharma files for patent protection for Astodrimer in Unknown territory [59] Updated 20 Apr 2020 |
| 17 Apr 2020 | Trial Update | Starpharma plans for Preclinical trials for the treatment of COVID-19 infections [59] Updated 20 Apr 2020 |
| 15 Apr 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in Australia (unspecified route) [58] Updated 17 Apr 2020 |
| 07 Apr 2020 | Phase Change - Marketed | Launched for Bacterial vaginosis in New Zealand (Vaginal) before April 2020 [24] Updated 13 Apr 2020 |
| 31 Jan 2020 | Phase Change - Marketed | Launched for Bacterial vaginosis (Prevention) in United Kingdom (Vaginal) [22] Updated 04 Feb 2020 |
| 31 Jan 2020 | Regulatory Status | Aspen announces intention to launch Fleurstat BV gel for Bacterial vaginosis Updated 04 Feb 2020 |
| 16 Jul 2019 | Phase Change - Marketed | Launched for Bacterial vaginosis in Germany (Vaginal) [14] Updated 18 Jul 2019 |
| 16 Jul 2019 | Regulatory Status | Mundipharma International makes regulatory submissions for Astodimer in multiple countries [14] Updated 18 Jul 2019 |
| 16 Apr 2019 | Phase Change - Marketed | Launched for Bacterial vaginosis in Australia (Vaginal, Gel) [23] Updated 22 Apr 2019 |
| 11 Apr 2019 | Regulatory Status | Starpharma conducts a meeting with US FDA for discussions related to potential approval of astodrimer in Bacterial vaginosis Updated 17 Apr 2019 |
| 27 Feb 2019 | Regulatory Status | Starpharma announces intention to launch Astrodrimer in Japan [15] Updated 28 Feb 2019 |
| 28 Jan 2019 | Phase Change - No development reported | No recent reports of development identified for research development in Human-papillomavirus-infections(Prevention) in Australia (Vaginal, Gel) Updated 28 Jan 2019 |
| 27 Dec 2018 | Regulatory Status | Aspen Pharmacare intends to launch Astodrimer for Bacterial vaginosis in Australia in the first half of 2019 [16] Updated 22 Apr 2019 |
| 27 Dec 2018 | Regulatory Status | MundiPharma intends to launch astodrimer for Bacterial vaginosis in Europe in the first half of 2019 [16] Updated 02 Jan 2019 |
| 20 Dec 2018 | Licensing Status | VivaGel® BV licensed to ITF Pharma in USA [6] Updated 28 Dec 2018 |
| 12 Dec 2018 | Patent Information | Starpharma has patent protection for SPL 7013 ophthalmic drops for viral conjunctivitis in USA [73] Updated 18 Dec 2018 |
| 12 Dec 2018 | Phase Change - Preclinical | Preclinical trials in Conjunctivitis in Australia (Ophthalmic) [73] Updated 18 Dec 2018 |
| 09 Jul 2018 | Licensing Status | Astodrimer is available for licensing in North America as of 09 Jul 2018. http://www.starpharma.com/ [17] Updated 11 Jul 2018 |
| 09 Jul 2018 | Regulatory Status | US FDA accepts NDA for astodrimer for Bacterial vaginosis (Recurrent, Prevention, Treatment) for Priority review [17] Updated 11 Jul 2018 |
| 27 Jun 2018 | Licensing Status | Astodrimer licensed to Mundipharma in European Union, Commonwealth of Independent States and rest of Latin America [2] Updated 03 Jul 2018 |
| 03 May 2018 | Licensing Status | Astrodimer licensed to Mundipharma in Asia, the Middle East, Africa and Latin America [1] Updated 11 May 2018 |
| 30 Apr 2018 | Regulatory Status | Starpharma completes rolling NDA submission for Bacterial vaginosis (Recurrent; Prevention) in USA [18] Updated 08 May 2018 |
| 27 Dec 2017 | Licensing Status | Astodrimer - Starpharma is available for licensing as of 21 Dec 2017. http://www.starpharma.com/ Updated 27 Dec 2017 |
| 21 Nov 2017 | Phase Change - Preregistration | Preregistration for Bacterial vaginosis (Recurrent) in USA (Vaginal) [20] Updated 24 Nov 2017 |
| 21 Nov 2017 | Phase Change - Preregistration | Preregistration for Bacterial vaginosis (Recurrent; Prevention) in USA (Vaginal) [20] Updated 24 Nov 2017 |
| 04 Nov 2017 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Herpes-simplex-virus-infections(Prevention, In volunteers) in Kenya (Vaginal, Gel) Updated 04 Nov 2017 |
| 04 Nov 2017 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Herpes-simplex-virus-infections(Prevention, In volunteers) in Puerto Rico (Vaginal, Gel) Updated 04 Nov 2017 |
| 04 Nov 2017 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Herpes-simplex-virus-infections(Prevention, In volunteers) in USA (Vaginal, Gel) Updated 04 Nov 2017 |
| 04 Nov 2017 | Phase Change - No development reported | No recent reports of development identified for phase-I development in HIV-infections(Prevention) in Puerto Rico (Vaginal, Gel) Updated 04 Nov 2017 |
| 04 Nov 2017 | Phase Change - No development reported | No recent reports of development identified for phase-I development in HIV-infections(Prevention) in USA (Vaginal, Gel) Updated 04 Nov 2017 |
| 25 Oct 2017 | Licensing Status | Astodrimer market licensed to Aspen Pharmacare in Australia and New Zealand [7] Updated 27 Nov 2017 |
| 25 Oct 2017 | Phase Change - Registered | Registered for Bacterial vaginosis in Australia (Vaginal) Updated 27 Nov 2017 |
| 07 Aug 2017 | Phase Change - III | Phase-III clinical trials in Bacterial vaginosis (Prevention) in Mexico (Vaginal) [21] Updated 28 Aug 2017 |
| 07 Aug 2017 | Phase Change - III | Phase-III clinical trials in Bacterial vaginosis in Thailand (Vaginal) [21] Updated 28 Aug 2017 |
| 07 Aug 2017 | Regulatory Status | Starpharma announces intention to submit NDA to US FDA for Bacterial vaginosis (Prevention) [21] Updated 10 Aug 2017 |
| 07 Aug 2017 | Scientific Update | Efficacy data from the two phase III trials in Bacterial vaginosis (Prevention) released by Starpharma [21] Updated 10 Aug 2017 |
| 01 Mar 2017 | Trial Update | Starpharma completes a phase III trial in Bacterial vaginosis (Prevention) in USA, Bulgaria, Czech Republic, Hungary, Ukraine, United Kingdom (Vaginal) (NCT02236156) Updated 19 Dec 2017 |
| 01 Mar 2017 | Trial Update | Starpharma completes a phase III trial in Bacterial vaginosis (Prevention) in USA, Canada and Puerto Rico (Vaginal) (NCT02237950) Updated 19 Dec 2017 |
| 11 Jan 2017 | Regulatory Status | Astodrimer receives Fast Track designation for Bacterial vaginosis [Vaginal,Gel] (Prevention, Treatment) in USA [26] Updated 13 Jan 2017 |
| 11 Jan 2017 | Regulatory Status | Astodrimer receives Qualified Infectious Disease Product status for Bacterial vaginosis (Prevention, Treatment) in USA [26] Updated 13 Jan 2017 |
| 05 May 2016 | Phase Change | Early research in Zika virus infection in Australia (unspecified route) [72] Updated 11 May 2016 |
| 24 Sep 2015 | Phase Change - Registered | Registered for Bacterial vaginosis in European Union (Vaginal) [27] Updated 28 Sep 2015 |
| 24 Sep 2015 | Phase Change - Registered | Registered for Bacterial vaginosis in Liechtenstein, Norway and Iceland (Vaginal) [27] Updated 28 Sep 2015 |
| 01 Sep 2015 | Phase Change - Preregistration | Preregistration for Bacterial vaginosis in European Union (Vaginal) before September 2015 [27] Updated 28 Sep 2015 |
| 06 Aug 2015 | Active Status Review | Clinical development is ongoing for HIV infections and Herpes simplex virus infections (Prevention) Updated 06 Aug 2015 |
| 06 Aug 2015 | Active Status Review | Starpharma is still in commercial partnering discussions and preparing regulatory filings for Bacterial vaginosis (symptomatic treatment) Updated 06 Aug 2015 |
| 04 Mar 2015 | Phase Change - III | Phase-III clinical trials in Bacterial vaginosis (Prevention) in Ukraine, United Kingdom and Czech Republic (Vaginal) (EudraCT 2014-000694-39) (NCT02236156) Updated 06 Aug 2015 |
| 31 Dec 2014 | Phase Change | Early research in Human papillomavirus infections (Prevention) in Australia (Vaginal) Updated 06 Aug 2015 |
| 16 Dec 2014 | Phase Change - III | Phase-III clinical trials in Bacterial vaginosis (Prevention) in Puerto Rico (Vaginal) (NCT02237950) Updated 23 Jan 2015 |
| 25 Sep 2014 | Phase Change - III | Phase-III clinical trials in Bacterial vaginosis (Prevention) in Hungary and Bulgaria (Vaginal) (NCT02236156) (EudraCT 2014-000694-39) Updated 22 Oct 2014 |
| 01 Sep 2014 | Phase Change - III | Phase-III clinical trials in Bacterial vaginosis (Prevention) in USA and Canada (Vaginal) (NCT02237950) Updated 22 Oct 2014 |
| 14 Jul 2014 | Regulatory Status | US FDA grants Special Protocol Assessment agreement for phase III trials of astodrimer in prevention of recurrent bacterial vaginosis [41] Updated 18 Jul 2014 |
| 23 Aug 2013 | Biomarker Update | Biomarkers information updated Updated 24 Oct 2021 |
| 01 Dec 2012 | Trial Update | Starpharma completes a phase III trial in Bacterial vaginosis in USA (NCT01577238) and a phase III trial in Bacterial vaginosis in USA, Belgium and Germany (NCT01577537) Updated 27 Nov 2013 |
| 01 Dec 2012 | Trial Update | Starpharma completes a phase II trial in Bacterial vaginosis (prevention) in USA (NCT01437722) Updated 26 Nov 2013 |
| 25 Jun 2012 | Trial Update | Starpharma completes enrolment in a pivotal phase III trial for Bacterial vaginosis in USA (NCT01577238) Updated 05 Jul 2012 |
| 25 Jun 2012 | Trial Update | Starpharma completes enrolment in a phase II (prevention) and III (treatment) trial for Bacterial vaginosis in the US [31] Updated 26 Jun 2012 |
| 22 Mar 2012 | Phase Change - III | Phase-III clinical trials in Bacterial vaginosis in Belgium, Germany and USA (Vaginal) Updated 01 May 2012 |
| 15 Aug 2011 | Phase Change - II | Phase-II clinical trials in Bacterial vaginosis (Prevention) in USA (Vaginal) Updated 16 Aug 2011 |
| 31 May 2011 | Trial Update | Starpharma completes a phase II trial in Bacterial vaginosis in USA (NCT01201057) Updated 01 May 2012 |
| 23 May 2011 | Scientific Update | Efficacy and adverse events data from a phase II trial in Bacterial vaginosis released by Starpharma [38] Updated 25 May 2011 |
| 25 Mar 2011 | Trial Update | Starpharma completes enrolment in its phase II trial for Bacterial vaginosis in USA (NCT01201057) Updated 19 Apr 2011 |
| 30 Jun 2010 | Phase Change - II | Phase-II clinical trials in Bacterial vaginosis (Treatment) in USA (Vaginal) Updated 14 Sep 2010 |
| 04 Aug 2009 | Scientific Update | Efficacy data from a phase I trial in HIV and Herpes simplex virus infections released by Starpharma Holdings [67] Updated 06 Aug 2009 |
| 31 Aug 2008 | Phase Change - I/II | Phase-I/II clinical trials in Herpes simplex virus infections in Australia (Vaginal) Updated 14 Sep 2010 |
| 31 Aug 2008 | Phase Change - I/II | Phase-I/II clinical trials in HIV infections in Australia (Vaginal) Updated 14 Sep 2010 |
| 12 May 2008 | Scientific Update | Adverse events data from a phase I trial in sexually abstinent women in the US and Kenya released by Starpharma [80] Updated 30 May 2008 |
| 24 Jul 2007 | Scientific Update | Final results from a phase I trial in healthy volunteers added to the adverse events and pharmacokinetic sections [68] Updated 26 Jul 2007 |
| 12 Jul 2007 | Phase Change - I | Phase-I clinical trials in Herpes simplex virus infections prevention in Puerto Rico (Topical) Updated 30 Mar 2008 |
| 12 Jul 2007 | Phase Change - I | Phase-I clinical trials in HIV infections prevention in Puerto Rico (Topical) Updated 30 Mar 2008 |
| 12 Jul 2007 | Phase Change - I | Phase-I clinical trials in HIV infections prevention in USA (Topical) Updated 30 Mar 2008 |
| 24 Oct 2006 | Phase Change - I | Phase-I clinical trials in Herpes simplex virus infections prevention in Kenya (Topical) Updated 26 Oct 2006 |
| 24 Oct 2006 | Phase Change - I | Phase-I clinical trials in Herpes simplex virus infections prevention in USA (Topical) Updated 26 Oct 2006 |
| 06 Oct 2006 | Company Involvement | Starpharma has proposed to acquire Dendritic Nanotechnologies Updated 06 Oct 2006 |
| 31 Aug 2006 | Trial Update | Starpharma has initiated enrolment in a phase I trial in healthy male volunteers in Australia Updated 26 Oct 2006 |
| 25 Jul 2006 | Regulatory Status | Starpharma filed an IND with the US FDA in June 2006 for genital herpes. The reveiw period was sucessfully completed in July 2006. Updated 25 Jul 2006 |
| 09 Jan 2006 | Regulatory Status | SPL 7013 gel received fast track status forn prevention of HIV infections in the US Updated 11 Jan 2006 |
| 06 Dec 2005 | Licensing Status | Starpharma signed a clinical trial agreement with Institute of Drug Technology Australia to conduct phase I clinical trials in Australia Updated 06 Dec 2005 |
| 16 Dec 2004 | Scientific Update | A clinical study has been added to the pharmacokinetics and adverse events section [69] Updated 09 Oct 2006 |
| 06 Sep 2004 | Trial Update | Starpharma has completed enrolment in a phase I trial in Australia Updated 06 Sep 2004 |
| 31 May 2004 | Phase Change - I | Phase-I clinical trials in Herpes simplex virus infections prevention in Australia (Topical) Updated 01 Jun 2004 |
| 31 May 2004 | Phase Change - I | Phase-I clinical trials in HIV infections prevention in Australia (Topical) Updated 01 Jun 2004 |
| 31 Mar 2004 | Company Involvement | Starpharma Pooled Development is now called Starpharma Updated 06 Oct 2005 |
| 20 Aug 2003 | Phase Change - I | The US FDA has cleared an IND for phase I trials of SPL 7013 Gel Updated 20 Aug 2003 |
| 06 May 2003 | Scientific Update | Data presented at the 16th International Conference on Antiviral Research (ICAR-2003) have been added to the Viral Infections pharmacodynamics section [81] Updated 06 May 2003 |
| 08 Oct 2001 | Phase Change - Preclinical | Preclinical development for HIV infections prevention in Australia (Topical) Updated 08 Oct 2001 |
| 06 May 2001 | Phase Change - Preclinical | Preclinical development for Herpes simplex virus infections prevention in Australia (Topical) Updated 06 May 2001 |
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