Barrier Therapeutics Reports Positive Results From Tinea Versicolor Study

Barrier Therapeutics announced positive results from its completed Phase IIb dose-ranging study for its novel oral antifungal product candidate pramiconazole. The drug met the primary endpoint of effectively treating tinea (pityriasis) versicolor, a common skin fungal infection. In addition, the secondary endpoints of complete cure, mycological cure and investigators' global assessment achieved statistical significance.

"With these data now in hand, we will begin to seek a development and commercialization partner for this important compound," Geert Cauwenbergh, CEO of Barrier Therapeutics, said.

The randomized, double-blind, placebo-controlled study enrolled 147 patients in six treatment groups. The study results demonstrated a positive linear dose response for the primary endpoint, "effectively treated" at day 28. Effectively treated was defined as significant reduction in disease signs and symptoms, including redness, scaling and itching, and complete mycological cure. Response rates for the primary endpoint ranged from 35 percent for the lowest dose to 85 percent for the highest dose as compared with 16 percent for placebo.

The drug was well-tolerated across all active treatment arms, and there were no reports of drug-related serious adverse events.

Pramiconazole is being developed as a potential short-course treatment for acute skin and mucosal fungal infections, as well as a potential once-weekly treatment for chronic fungal infections such as onychomycosis.