• 100% enrolment for phase 3 trials of VivaGel^® BV for prevention of recurrence 
• Trial completion expected Q1 CY2017 
• Favourable revision to FDA guidance for BV treatment product opportunity 

Melbourne, Australia; 13 October 2016: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced completion of patient enrolment for its pivotal phase 3 trials evaluating the efficacy and safety of VivaGel^® BV for prevention of recurrent bacterial vaginosis (BV). Trial completion is expected in the first quarter of calendar 2017, with topline results available early-to-mid second quarter of calendar 2017.

The two phase 3 trials are being conducted according to the requirements of the US Food and Drug Administration (FDA) and the European authorities to support global marketing applications for VivaGel^® BV for the prevention of recurrent BV. Starpharma also secured the binding agreement of FDA on the trial design including the primary endpoint, by way of a Special Protocol Assessment (SPA). The SPA minimises regulatory risk associated with acceptance of the trial data to support marketing approval. The studies are being conducted across multiple sites in the US, Canada, Mexico, Europe and Asia.

The two double-blind, randomised, placebo-controlled trials are identical in design. The primary endpoint of the studies is recurrence of BV during the 16-week treatment period. The primary objective of the study is to demonstrate that the rate of BV recurrence in women using VivaGel^® BV is lower than the rate of BV recurrence in women using a placebo gel during the 16-week treatment period. After the treatment period, there is a 12-week follow-up period off treatment which will assess secondary endpoints including safety.

Starpharma Chief Executive Officer, Dr Jackie Fairley, said: “We are delighted to have achieved full enrolment of our pivotal phase 3 trials for this indication and look forward to trial completion early next year.

“There are no approved products for this indication, so we have an opportunity to be first in class with VivaGel^® BV for the prevention of BV recurrence. This important differentiating factor is a significant commercial advantage recognised by potential partners. There is significant unmet medical need for this chronic condition, where the global market is estimated to be worth around $1 billion annually.”

Starpharma has already developed VivaGel^® BV for bacterial vaginosis treatment separate to the prevention of recurrence indication. VivaGel^® BV is approved in Europe for the treatment of BV, including relief of symptoms, and is well advanced in regulatory review in other markets, with launch planned in coming months.

Significantly, in a related development, the FDA recently issued a new draft clinical guidance for the development of products for BV treatment. This new guidance recommends the assessment of the primary endpoint for efficacy in treatment studies be soon after cessation of treatment (End of Treatment: day 7-14 post randomisation), and not 2‑3 weeks after treatment is ceased, which was the required timing previously. This development is particularly important as the new FDA revised End of Treatment time point is consistent with Starpharma’s 2012 phase 3 results for VivaGel^® BV for treatment of BV, which showed, in both studies, highly statistically significant Clinical Cure of BV at the End of Treatment time point.

Starpharma has licensed VivaGel^® BV to Aspen Pharmacare for Australia and New Zealand and has advanced negotiations underway with a number of parties for other regions, including Europe. Naturally, the shift in FDA requirements has positive implications in terms of partnering for VivaGel^® BV - for both the treatment and the prevention of recurrent BV product opportunities.

The FDA draft guidance is available:  
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510948.pdf.

About VivaGel^® BV  

VivaGel^® (SPL7013, astodrimer sodium) is a non-antibiotic agent formulated as a vaginally applied gel (VivaGel^® BV) for treatment of BV and prevention of BV recurrence. VivaGel^® BV has been approved in Europe as a topical treatment for the rapid relief of BV, including symptoms of unpleasant vaginal odour and discharge.  

About Bacterial Vaginosis (BV)

Bacterial vaginosis is the most common cause of vaginal infection for women of childbearing age, and affects around 30% of women in the US. It is a highly recurrent condition with 50-60% of sufferers having it recurrently. BV is caused by an imbalance of naturally occurring bacterial flora (the usual bacteria found in a woman's vagina). Smoking, the use of some hygiene products and several other risk factors are linked to a higher risk of developing BV. The global market value for the prevention of recurrent BV is estimated to be more than US$1 billion.  

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