Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Astodrimer - Starpharma

Drug Profile

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; VivaGel; VivaGel®BV

Latest Information Update: 18 Jun 2021

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

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • 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 Conjunctivitis; 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 Human papillomavirus infections; Zika virus infection

Most Recent Events

  • 12 Jun 2021 Launched for COVID-2019 infections in India (Intranasal) before June 2021
  • 12 Jun 2021 Launched for COVID-2019 infections in United Kingdom (Intranasal) before June 2021
  • 11 Jun 2021 Registered for COVID-2019 infections in India (Intranasal) before June 2021

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 will be available under the brand name BETADINETM BV Gel and as Betafem® BV in the UK. Astodrimer is approved in the EU for the treatment of bacterial vaginosis. The company is seeking approval for astrodimer 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.

Company Agreements

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. [1]

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. [2] [3]

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. [4]

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 [5] . 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 [6] .

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 [7] .

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 [8] [9] [10] .

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 [11] .

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 [12] [13] . 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 [14] . 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 [15] [16] [17] [18] .

Bacterial vaginosis (BV) - treatment

In November 2019, astodrimer was launched in the UK, under the brand name Betafem® BV gel [19] .

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 [11] .

In April 2019, Aspen Pharmacare launched astodrimer under the brand name Fleurstat™ BVgel for the treatment of bacterial vaginosis as an OTC product [20] . Earlier in October 2017, the Therapeutic Goods Administration of Australia approved astodrimer for the same indication [4] .

As of April 2020, astodrimer is available in New Zealand under the brand name Fleurstat™ BVgel [21] .

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 [22] .

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 [23] .

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 [24] .

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) [25] [26] . 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 [27] [28] [29] . These trials were conducted under the FDA's Special Protocol Assessment (SPA) scheme [30] [31] [32] .

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 [33] .

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% [34] . The trial met its primary endpoint of the number of patients with clinical cure over days 21 to 30 [8] [35] .

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 [23] .

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 [36] . 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 [37] . 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 [38] . 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) [18] .

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 [28] [8] [39] [27] . 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 [38] .

COVID-2019 infections

Prior to June 2021, Astodrimer registered and launched in the United kingdom and India [40] .

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 [41] .

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 [42] .

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 [43] .

In June 2021, Starpharma and the Scripps Research Institute released preclinical data of astodrimer against COVID-2019 infections [43] [44] .

In preclinical studies, astodrimer stopped infection when applied to cells before or after exposure to the virus [41] .

In August 2020, Starpharma released preclinical data of astodrimer nasal spray against COVID-2019 infections [45] . The therapy has demonstrated antiviral efficacy against different isolates of SARS-CoV2, including those from Australia, Europe and the US [46] .

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 [47] [48] . 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 [49] [48] .

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 [50] .

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 [51] . 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 [52] [53] .

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 [54] . Results have been reported [55] .

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) [56] [57] .

Starpharma was awarded a $US20.3 million grant by the NIAID in the US in October 2005, for the development of astodrimer [58] .

In July 2003, the US FDA cleared an Investigational New Drug Application (IND) filed by StarPharma for astodrimer in HIV infections [59] .

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 [46] .

Zika virus infections

In May 2016, Starpharma announced that astrodimer showed potent anti-viral activity against Zika virus in laboratory studies [60] .

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 [61] .

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 [11] [62] [63] .

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 [64] .

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 [65] .

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 [48] .

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 [61]

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 [35] .

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 [9] .

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 [66] . 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

not specified

PSA

1

herpes genitalis

Exclusion

syndecan binding protein

1

herpes genitalis

Outcome Measure

CXCR4

CCR5

1

1

herpes simplex virus infections

not specified

PSA

1

herpes simplex virus infections

Exclusion

syndecan binding protein

1

herpes simplex virus infections

Outcome Measure

CXCR4

CCR5

1

1

HIV infections

not specified

PSA

1

HIV infections

Exclusion

syndecan binding protein

1

HIV infections

Outcome Measure

CXCR4

CCR5

1

1

Biomarker

Drug Name Biomarker Name Biomarker Function
Astodrimer - Starpharma CCR5 Outcome Measure
CXCR4 Outcome Measure
PSA not specified
syndecan binding protein Exclusion
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

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 India Intranasal / Spray Starpharma 12 Jun 2021
COVID 2019 infections - In volunteers, Prevention Phase I Australia Intranasal / Spray Starpharma 06 Jan 2021
Conjunctivitis - - Preclinical Australia Ophthalmic / Drops Starpharma 12 Dec 2018
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
QIPD 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
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 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 [56] [57] .

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 [35] .

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 [56] [72] .

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 [57] .

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 [68] .

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 [71] .

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 [69] .

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 [46] .

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 [49] [45] . In another study, SPL 7013 resulted in no detectable binding of the SARS-CoV-2 spike protein to the cells expressing the hACE2 receptor [46] .

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 [43] [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 [71] .

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%) [35] .

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% [18] [70] [36] [37] .

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 [55] .

Future Events

Expected Date Event Type Description Updated
30 Apr 2021 Regulatory Status Starpharma intends to launch Astodrimer for COVID-2019 infections (Spray) in United Kingdom in April 2021 [67] 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 [13] 22 Apr 2019
02 Jan 2019 Regulatory Status MundiPharma intends to launch astodrimer for Bacterial vaginosis in Europe in the first half of 2019 [13] 02 Jan 2019

Development History

Event Date Update Type Comment
12 Jun 2021 Phase Change - Marketed Launched for COVID-2019 infections in India (Intranasal) before June 2021 [40] Updated 18 Jun 2021
12 Jun 2021 Phase Change - Marketed Launched for COVID-2019 infections in United Kingdom (Intranasal) before June 2021 [40] Updated 18 Jun 2021
11 Jun 2021 Phase Change - Registered Registered for COVID-2019 infections in India (Intranasal) before June 2021 [40] Updated 18 Jun 2021
11 Jun 2021 Phase Change - Registered Registered for COVID-2019 infections in United Kingdom (Intranasal) before June 2021 [40] Updated 18 Jun 2021
01 Jun 2021 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in United Kingdom (Intranasal) before June 2021 [44] 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 [44] [43] 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 [67] Updated 03 Jun 2021
03 Mar 2021 Phase Change - Preclinical Preclinical trials in Influenza A virus H3N2 subtype in USA (Intranasal) [46] Updated 08 Mar 2021
03 Mar 2021 Phase Change - Preclinical Preclinical trials in Middle East respiratory syndrome coronavirus in USA (Intranasal) [46] Updated 08 Mar 2021
03 Mar 2021 Phase Change - Preclinical Preclinical trials in Severe acute respiratory syndrome in USA (Intranasal) [46] 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 [46] 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 [41] Updated 23 Dec 2020
14 Sep 2020 Scientific Update Preclinical pharmacodynamics data in COVID-2019 infections released by Starpharma [49] Updated 15 Sep 2020
25 Aug 2020 Scientific Update Preclinical pharmacodynamics data in COVID-2019 infections released by Starpharma [45] 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 [48] Updated 20 Apr 2020
17 Apr 2020 Trial Update Starpharma plans for Preclinical trials for the treatment of COVID-19 infections [48] Updated 20 Apr 2020
15 Apr 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in Australia (unspecified route) [47] Updated 17 Apr 2020
07 Apr 2020 Phase Change - Marketed Launched for Bacterial vaginosis in New Zealand (Vaginal) before April 2020 [21] Updated 13 Apr 2020
31 Jan 2020 Phase Change - Marketed Launched for Bacterial vaginosis (Prevention) in United Kingdom (Vaginal) [19] 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) [11] Updated 18 Jul 2019
16 Jul 2019 Regulatory Status Mundipharma International makes regulatory submissions for Astodimer in multiple countries [11] Updated 18 Jul 2019
16 Apr 2019 Phase Change - Marketed Launched for Bacterial vaginosis in Australia (Vaginal, Gel) [20] 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 [12] 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 [13] 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 [13] Updated 02 Jan 2019
20 Dec 2018 Licensing Status VivaGel® BV licensed to ITF Pharma in USA [1] Updated 28 Dec 2018
12 Dec 2018 Patent Information Starpharma has patent protection for SPL 7013 ophthalmic drops for viral conjunctivitis in USA [61] Updated 18 Dec 2018
12 Dec 2018 Phase Change - Preclinical Preclinical trials in Conjunctivitis in Australia (Ophthalmic) [61] 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/ [14] Updated 11 Jul 2018
09 Jul 2018 Regulatory Status US FDA accepts NDA for astodrimer for Bacterial vaginosis (Recurrent, Prevention, Treatment) for Priority review [14] 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 [3] Updated 03 Jul 2018
24 Jun 2018 Biomarker Update Biomarkers information updated Updated 31 Aug 2018
03 May 2018 Licensing Status Astrodimer licensed to Mundipharma in Asia, the Middle East, Africa and Latin America [2] Updated 11 May 2018
30 Apr 2018 Regulatory Status Starpharma completes rolling NDA submission for Bacterial vaginosis (Recurrent; Prevention) in USA [15] 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) [17] Updated 24 Nov 2017
21 Nov 2017 Phase Change - Preregistration Preregistration for Bacterial vaginosis (Recurrent; Prevention) in USA (Vaginal) [17] 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 [4] 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) [18] Updated 28 Aug 2017
07 Aug 2017 Phase Change - III Phase-III clinical trials in Bacterial vaginosis in Thailand (Vaginal) [18] Updated 28 Aug 2017
07 Aug 2017 Regulatory Status Starpharma announces intention to submit NDA to US FDA for Bacterial vaginosis (Prevention) [18] Updated 10 Aug 2017
07 Aug 2017 Scientific Update Efficacy data from the two phase III trials in Bacterial vaginosis (Prevention) released by Starpharma [18] 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 [23] Updated 13 Jan 2017
11 Jan 2017 Regulatory Status Astodrimer receives Qualified Infectious Disease Product status for Bacterial vaginosis (Prevention, Treatment) in USA [23] Updated 13 Jan 2017
05 May 2016 Phase Change Early research in Zika virus infection in Australia (unspecified route) [60] Updated 11 May 2016
24 Sep 2015 Phase Change - Registered Registered for Bacterial vaginosis in European Union (Vaginal) [24] Updated 28 Sep 2015
24 Sep 2015 Phase Change - Registered Registered for Bacterial vaginosis in Liechtenstein, Norway and Iceland (Vaginal) [24] Updated 28 Sep 2015
01 Sep 2015 Phase Change - Preregistration Preregistration for Bacterial vaginosis in European Union (Vaginal) before September 2015 [24] 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 [38] Updated 18 Jul 2014
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 [28] 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 [35] 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 [55] 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 [68] 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 [56] 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 [57] 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 [69] 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

References

  1. US VivaGel(R) BV licensed for A$142M milestones, plus royalties.

    Media Release
  2. Mundipharma licenses Starpharma's VivaGel(R) BV .

    Media Release
  3. Starpharma licenses VivaGel(R) BV to Mundipharma for Europe.

    Media Release
  4. VivaGel(R) BV granted marketing approval in Australia.

    Media Release
  5. Dendritic Nanotechnologies to be Acquired by Australian Nanobiotech Company Starpharma Holdings Ltd.

    Media Release
  6. Starpharma - Pdf Status and Change of Name.

    Media Release
  7. Starpharma Announces Alliance with IDT Ltd to Conduct Human Trials.

    Media Release
  8. Starpharma Commences Bacterial Vaginosis Prevention Study of VivaGel(R).

    Media Release
  9. US Patent Grant Extends VivaGel(R) Coverage to 2024.

    Media Release
  10. Starpharma Signs Collaborative Research Agreement with Stiefel Laboratories, Inc.

    Media Release
  11. Quarterly Cashflow Report-Jul 16th, 2019.

    Media Release
  12. Starpharma Interim Report and Half-Year Financial Results- 27 Feb 2019.

    Media Release
  13. US FDA requests further data for VivaGel(R) BV approval.

    Media Release
  14. VivaGel(R) BV NDA advances to next stage of FDA review.

    Media Release
  15. Starpharma completes US New Drug Application for VivaGel(R) BV .

    Media Release
  16. VivaGel(R)BV treatment clinical submission under rolling submission.

    Media Release
  17. Starpharma: NDA Submission for VivaGel(R) BV in the US.

    Media Release
  18. Starpharma: Successful VivaGel(R) Phase 3 Results and NDA Planned for rBV.

    Media Release
  19. Shareholder Update January 2020: starpharma.

    Media Release
  20. First VivaGel BV launch globally in Australia by Aspen.

    Media Release
  21. Quarterly Cashflow and Activity Report.

    Media Release
  22. First Asian Regulatory Approvals Received for VivaGel(R) BV.

    Media Release
  23. VivaGel(R) BV granted QIDP and Fast Track designation by US FDA.

    Media Release
  24. EU Marketing Approval Granted for VivaGel(R) BV.

    Media Release
  25. A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Assess the Efficacy and Safety of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

    ctiprofile
  26. A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Assess the Efficacy and Safety of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

    ctiprofile
  27. Starpharma presenting at Nomura Biotech Investment conference.

    Media Release
  28. Full enrolment achieved for BV Phase 2 trial and first Phase 3 trial.

    Media Release
  29. Starpharma's VivaGel Phase 3 treatment trials 60% enrolled.

    Media Release
  30. SPL receives FDA Special Protocol Assessment for BV Phase 3.

    Media Release
  31. Appendix 4C - Quarterly Cashflow report.

    Media Release
  32. Starpharma Holdings Ltd Commences Pivotal Phase 3 Vivagel(Rm) Trials for Bacterial Vaginosis Treatment.

    Media Release
  33. Starpharma secures European (EMA) agreement on BV treatment Phase 3.

    Media Release
  34. A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel) Administered Vaginally in the Treatment of Bacterial Vaginosis.

    ctiprofile
  35. VivaGel(R) Demonstrates Efficacy in Bacterial Vaginosis.

    Media Release
  36. A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Determine the Efficacy and Safety of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis

    ctiprofile
  37. A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Determine the Efficacy and Safety of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis

    ctiprofile
  38. FDA Grants Special Protocol Assessment (SPA) Agreement for Starpharma Phase 3 Recurrent BV Trial.

    Media Release
  39. A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis.

    ctiprofile
  40. Viraleze registered for sale in Covid-ravaged India.

    Media Release
  41. VIRALEZE COVID-19 nasal spray study to commence in January.

    Media Release
  42. A randomized, double-blind, placebo-controlled investigation of the safety, tolerability and pharmacokinetics of 1% SPL7013 nasal spray in healthy volunteers when administered four times a day for 14 days

    ctiprofile
  43. VIRALEZE SPL7013 highly active in UK variant of coronavirus.

    Media Release
  44. Scripps Research Institute testing shows Viraleze highly active against UK COVID strain.

    Media Release
  45. Starpharma SPL7013 Nasal Spray for COVID-19 Development Update.

    Media Release
  46. SPL7013 active against other pandemic coronaviruses.

    Media Release
  47. SPL7013 shows significant activity against SARS-CoV-2 (coronavirus).

    Media Release
  48. Starpharmas SPL7013 Shows Significant Activity Against SARS-CoV-2 (coronavirus).

    Media Release
  49. Starpharmas SPL7013 COVID-19 Nasal Spray Virucidal Against SARS-CoV-2.

    Media Release
  50. Vivagel(TM) Receives Fast Tracks Status from FDA.

    Media Release
  51. U.S. Clinical Trial of VivaGel(TM) for Genital Herpes Commences.

    Media Release
  52. New England Journal of Medicine Publishes Results From a RELISTOR Phase 3 Clinical Study.

    Media Release
  53. NIH Funds Clinical Development of VivaGel(TM) for Genital Herpes.

    Media Release
  54. U.S. NIH Funded Trial of VivaGel(TM) in Sexually Active Young Women Commences.

    Media Release
  55. VivaGel(R) Demonstrates Anti-HIV and Herpes Activity Following Human Administration.

    Media Release
  56. Starpharma Presents Positive Results of Clinical Study of VivaGel(TM) in Men at 4th International AIDS Society Conference.

    Media Release
  57. Clinical Study Shows STARPHARMA's VivaGel(tm) is Safe.

    Media Release
  58. Development of Starpharma's VivaGel(TM) Accelerated with $US20m Funding from NIH.

    Media Release
  59. Starpharma Announces Success of FDA Application for Human Trials of Anti-HIV Product (VivaGel(tm)).

    Media Release
  60. VivaGel Active against Zika Virus.

    Media Release
  61. US patent granted for SPL7013 eye drops for conjunctivitis.

    Media Release
  62. Quarterly Cashflow Report-30 January 2019.

    Media Release
  63. Starpharma to present at OTCQX Virtual Investor Conference.

    Media Release
  64. Starpharma awarded $1M MRFF funding for COVID-19 spray.

    Media Release
  65. Starpharma Announces $15.6 million Capital Raising.

    Media Release
  66. Key VivaGel (Rm) Patent Approved in Japan.

    Media Release
  67. VIRALEZE(Tm) to be launched with LloydsPharmacy in the UK.

    Media Release
  68. Starpharma Reports Positive VivaGel(R) Clinical Study Results.

    Media Release
  69. Bernstein DI, Bourne N, Ayisi NK, Ireland J, Matthews B, et al. Evaluation of formulated dendrimer SPL7013 as a microbicide. Antiviral-Res 2003;5766.

  70. A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL147 Administered Orally Daily to Subjects With Solid Tumors or Lymphoma.

    ctiprofile
  71. Boume N, Bernstein DI, GONG Y, Holan G, Matthews B, et al. Second-generation dendrimers as topical microbicides against genital HSV-2 infection: studies in vitro and in a mouse model. Antiviral-Res 2001;5068 (plus poster).

  72. Paull J, Chen M, Millwood I, Wand H, Poynten M, Law M, et al. SPL7013 Gel (VivaGel TM), a topical microbicide in development for prevention of HIV and genital herpes, shown to be well tolerated and comparable with placebo after seven days administration in healthy males. 4th-IAS-2007-Late 2007;23.

Back to top