Starpharma to advance with phase III studies for VivaGel

Starpharma has kicked off the year with a tick from the US Food and Drug Administration for its study design for phase III trials of VivaGel under the FDA’s Special Protocol Assessment scheme.

The agreement with the FDA confirms that the study design, endpoints, statistical analyses and other aspects of the trial are acceptable for achieving regulatory approval.

The company intends to undertake two phase III trials of VivaGen for the treatment of bacterial vaginosis (BV) this year, with results anticipated before the year’s end.

Assuming positive results, the company intends to partner in order to progress to marketing stage.

“Following our recent financing, we are also implementing various initiatives in collaboration with our CRO to expedite the trial timelines as much as possible,” said Dr Jackie Fairley, Chief Executive Officer of Starpharma.

Starpharma’s (ASX:SPL) is steady at $1.20.