FDA grants Starpharma Phase 3 trial

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THE ROADHOUSE PHARMACY: Starpharma Holdings (ASX: SPL) announced the US Food and Drug Administration (FDA) has granted Special Protocol Assessment (SPA) agreement on the design and planned analyses of the phase 3 clinical studies of the VivaGel® bacterial vaginosis (BV) product for the prevention of recurrent BV.

Starpharma said the favourable SPA outcome provides a binding agreement from the FDA that the phase 3 clinical study design, endpoints, statistical analyses and other aspects of the planned studies adequately address objectives in support of a US regulatory submission for approval of the product.

The granting of SPA agreement by the FDA follows an earlier agreement of the European Medicines Agency (EMA) on the design of the phase 3 studies.

Starpharma will now commence two phase 3 clinical trials of VivaGel® for the prevention of recurrent BV at sites in North America, Europe and Asia.

The two phase 3, double-blind, randomised, placebo-controlled trials will be identical in design and will compare the rate of BV recurrence in women using VivaGel® to the rate of recurrence in women using a placebo gel during a 16 week treatment period.

Approximately 600 women will be recruited into each study.

“Receiving agreement on the SPA 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,” Starpharma chief executive officer Dr Jackie Fairley said in the company’s announcement to the Australian Securities Exchange.

“This significantly reduces overall development risk for VivaGel®.

“SPA agreement from the FDA is protected by US law and gives Starpharma certainty and confidence that the studies will support a regulatory submission for the approval of VivaGel® for the prevention of recurrent BV in the US.”

VivaGel is a non-antibiotic agent formulated as a vaginally applied gel for prevention of BV recurrence.

It is also being developed for the management of BV symptoms, which include unpleasant vaginal odour and discharge, and regulatory submissions to support the symptomatic relief indication are also planned for 2HCY14.

Starpharma explained there are no approved products for the prevention of recurrent BV and so VivaGel® will be a world-first therapy for this troublesome condition.

Bacterial vaginosis affects around 1 in 3 women and recurs in approximately 50 per cent of women within 12 months.

In the previous exploratory phase 2 clinical trial, more than 80 per cent of women receiving 1 per cent VivaGel® remained BV-free at 16 weeks and the product also provided protection against the occurrence of BV symptoms.

Starpharma said formal market research with both patients and clinicians and from Key Opinion Leaders strongly supports the demand for a product such as VivaGel® in the management of BV.

Website: www.starpharma.com