Starpharma Holdings (ASX:SPL) has announced completion of its international, multicentre, phase 3 clinical studies evaluating VivaGel BV for the prevention of recurrent bacterial vaginosis (rBV).
The company said it expects top-line results of the trials to be available in the second quarter of 2017.
The two pivotal phase 3, double-blind, randomised, placebo-controlled trials compare the rate of BV recurrence in women using VivaGel BV to the rate of recurrence in women using a placebo gel during a 16 week treatment period with the primary endpoint measured as patients complete the treatment period.
The trials were conducted at sites across the US, Europe, Canada, Mexico and Asia. The company said top-line results of the trials will be available late in the second quarter following data collation, routine blinded QC and bio-statistical programming of the extensive data set.
Starpharma has been granted a Special Protocol Agreement (SPA) by the FDA which provides the company with binding FDA agreement on the trial design including the primary endpoint. The achievement of an SPA significantly reduces the US regulatory risk associated with clinical development, by specifying upfront the FDA’s agreement with the trial design and providing certainty in the trial data required to support marketing approval.
According to Starpharma CEO, Dr Jackie Fairley, “The completion of these pivotal phase 3 trials is a significant milestone for Starpharma. The market for prevention of BV recurrence is estimated to be worth more than US$1 billion and there are currently no approved products. As we look forward to the release of results in the next quarter, we are in parallel preparing our US FDA marketing applications, and are engaged in active negotiations for commercial rights to VivaGel BV. The granting of QIDP designation and Fast Track status by the FDA for both treatment of BV and prevention of rBV in January are also important developments, attracting significant commercial interest.”
VivaGel BV is already approved in Europe for the treatment and relief of BV symptoms and regulatory reviews including by the TGA are well advanced. VivaGel BV has been licensed in Australia and New Zealand to Aspen Pharmacare and extensive licensing discussions are also underway globally.