BARRIER THERAPEUTICS RELEASES PHASE III RESULTS

Barrier Therapeutics, a pharmaceutical company developing and commercializing products in the field of dermatology, has announced that its oral antifungal product candidate, hyphanox, failed to reach the primary endpoint of therapeutic cure in its Phase III noninferiority trial for the treatment of vaginal candidiasis, commonly known as a vaginal yeast infection.

The trial was designed to demonstrate that a single dose of hyphanox, a novel patented formulation of the antifungal itraconazole, is not inferior to a single dose of fluconazole.

Results from this Phase III trial indicate that 26 percent (105/403) of subjects treated with hyphanox reached the primary endpoint as compared to 37 percent (148/397) treated with fluconazole. The primary efficacy endpoint is the proportion of subjects who had a therapeutic cure at the final visit, which was 25 days post-treatment. For purposes of this trial, in order to be considered a "therapeutic cure," the subject must have had both a mycological cure and a clinical cure at Day 25. Mycological cure is based on a negative microscopic examination and negative culture for Candida. Clinical cure is based on physician and patient assessment of signs and symptoms. The trial was conducted at 60 centers in the U.S. and Central America and enrolled a total of over 1200 subjects, of which 800 showed both positive microscopy and culture for the yeast, Candida.

Hyphanox achieved noninferiority for the secondary endpoint of clinical cure. The clinical cure rate for hyphanox was 58 percent (233/403) compared to 65 percent (256/397) for fluconazole. Hyphanox failed to achieve noninferiority for the secondary endpoint of mycological cure, which assessed the presence of yeast at the test of cure visit (Day 25). The mycological cure rate for hyphanox was 36 percent (143/403) compared to 49 percent (193/397) for fluconazole. An analysis of the time to resolution, a secondary endpoint based on the subject diary, showed hyphanox achieved noninferiority with fluconazole.

There were no treatment related serious adverse events in the trial. Non-serious, treatment related adverse events were evenly distributed between the groups at a rate of approximately 14 percent.