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  .
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   . 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  . 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     .
Bacterial vaginosis (BV) - treatment
In November 2019, astodrimer was launched in the UK, under the brand name Betafem® BV gel  .
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  .
In April 2019, Aspen Pharmacare launched astodrimer under the brand name Fleurstat™ BVgel for the treatment of bacterial vaginosis as an OTC product  . Earlier in October 2017, the Therapeutic Goods Administration of Australia approved astodrimer for the same indication  .
As of April 2020, astodrimer is available in New Zealand under the brand name Fleurstat™ BVgel  .
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  .
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  .
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  .
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)   . 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    . These trials were conducted under the FDA's Special Protocol Assessment (SPA) scheme    .
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  .
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%  . The trial met its primary endpoint of the number of patients with clinical cure over days 21 to 30   .
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  .
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  . 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  . 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  . 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)  .
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     . 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  .
Prior to June 2021, Astodrimer registered and launched in the United kingdom and India  .
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  .
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  .
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  .
In June 2021, Starpharma and the Scripps Research Institute released preclinical data of astodrimer against COVID-2019 infections   .
In preclinical studies, astodrimer stopped infection when applied to cells before or after exposure to the virus  .
In August 2020, Starpharma released preclinical data of astodrimer nasal spray against COVID-2019 infections  . The therapy has demonstrated antiviral efficacy against different isolates of SARS-CoV2, including those from Australia, Europe and the US  .
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   . 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   .
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  .
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  . 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   .
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  . Results have been reported  .
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)   .
Starpharma was awarded a $US20.3 million grant by the NIAID in the US in October 2005, for the development of astodrimer  .
In July 2003, the US FDA cleared an Investigational New Drug Application (IND) filed by StarPharma for astodrimer in HIV infections  .
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  .
Zika virus infections
In May 2016, Starpharma announced that astrodimer showed potent anti-viral activity against Zika virus in laboratory studies  .
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  .
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    .
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  .
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  .