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Barrier’s Antifungal Drug Meets Phase IIb Endpoints

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Barrier Therapeutics achieved positive results from its Phase IIb dose ranging study for its antifungal candidate pramiconazole (previously known as Azoline). Pramiconazole met the primary endpoint of effectively treating tinea (pityriasis) versicolor, a common skin fungal infection characterized by a discolored, scaly, itchy rash primarily on the back, chest and upper arms. Also, the secondary endpoints of complete cure, mycological cure and investigators’ global assessment achieved statistical significance.

The randomized, double-blind, placebo-controlled study enrolled 147 patients in six treatment groups. Results showed a positive linear dose response for the primary endpoint “effectively treated” at day 28, which 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% for the lowest dose to 85% for the highest dose as compared to 16% for placebo. The drug was well tolerated across all treatment arms and no serious adverse events were reported.

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