FDA approves StarPharma's VivaGel trial design

US regulator FDA has approved the design of Starpharma’s (ASX:SPL) planned phase III trials into using VivaGel for the prevention of recurrent bacterial vaginosis (BV).

The FDA has granted Starpharma a Special Protocol Assessment, signifying that the design and planned statistical analyses of the trial will be sufficient for a regulatory application.

The European Medicines Agency has already granted a similar approval for the trial design. Starpharma now plans to commence the two phase III trials at sites in North America, Europe and Asia.

Both trials will be identical in design and involve around 600 women each. They will compare the rate of BV occurrence using VivaGel against a placebo over a 16-week period.

Starpharma CEO Dr Jackie Fairley said receiving an SPA agreement “is an important and very positive development, as it effectively eliminates the US regulatory risk associated with clinical development, by specifying upfront the FDA’s agreed trial design”.

Bacterial vaginosis is the most common cause of vaginal infection for women of childbearing age and has been linked to stillbirth, pregnancy complications and increased susceptibility to STIs including HIV.

Starpharma had originally been developing VivaGel as a treatment for BV, but after a 2012 phase III trial failed to reach its primary endpoint, the company shifted focus to the prevention of BV recurrence, as well as to the management of symptoms.

There are no currently approved products for the prevention of BV recurrence.

Starpharma (ASX:SPL) shares were trading 0.85% higher at $0.59 as of around 1 pm on Monday.