Starpharma kicks off phase III VivaGel trials

Starpharma Holdings (ASX:SPL) has commenced two concurrent phase III trials of its VivaGel formulation as a treatment for bacterial vaginosis (BV).

The company will conduct the clinical trials across 30 international sites, primarily in the US. Each trial will involve around 220 patients, with full results expected by the end of the year.

The data from the trials will form part of Melbourne-based Starpharma's New Drug Application with the US Food and Drug Administration.

The agency granted Starpharma a Special Protocol Assessment (SPA) approval for the trials in January, signifying that the trial design is acceptable for FDA approval purposes. The European Medicines Agency has also signed off on the trials.

Starpharma CEO Dr Jackie Fairley said the commencement of the trials is an important milestone for both VivaGel and the company.

“This represents one of only very few examples of where a new chemical entity drug has been discovered by Australian scientists and developed by an Australian company through to pivotal phase III trials,” Farley said.

BV is the most common vaginal infection worldwide, affecting an estimated one third of the adult female population in the US. Conventional antibiotic treatments have low cure rates, high rates of recurrence, unpleasant side effects and high bacterial resistance.

Previous trials of VivaGel indicate it can be more effective than traditional treatments, and because it is a topical treatment it is not absorbed into the bloodstream, preventing some side effects.

Starpharma estimates that the market for BV treatments is worth around $300-$350 million. VivaGel has applications besides BV. Starpharma is also currently preparing to launch a line of VivaGel coated condoms, in partnership with Ansell and Okamoto.

The condoms, designed to inhibit transmission of STIs including HIV and genital herpes, will be marketed under the VivaGel brand. Starpharma has forecast that these products will generate royalties of over $100 million.

Starpharma separately revealed that a substantial shareholder, investment company M&G, has increased its holdings in the company by 1% to 8.01%.

Starpharma (ASX:SPL) shares fell 2.44% during Tuesday's trading to $1.60. But the shares have been trending upwards every month since October last year, when the price dropped below $1.00.