Findings from two Phase III studies for Promius Pharma’s investigational psoriasis drug DFD-01 show that the agent achieved the primary endpoint at day 15. The primary endpoint was the proportion of patients achieving treatment success at day 15 for both studies. In addition, both studies met a secondary endpoint of treatment success at day 29. Treatment success was analyzed using Cochran–Mantel–Haenszel.

DFD-01 is a novel formulation of betamethasone dipropionate, 0.05% available in an emollient spray.

Over 500 adult patients with moderate psoriasis were enrolled in both studies and randomized to receive DFD-01, augmented betamethasone dipropionate lotion or vehicle. Mean BSA was between 13% and 14% for all groups and there were no notable differences between groups or studies.

DFD-01 improved signs of erythema, scaling and elevation in target lesions, with many located in difficult to treat areas. Both DFD-01 and its Vehicle were well tolerated. According to the investigators, the majority of adverse events (AEs) were mild to moderate with no notable increases in adverse events between 2 and 4 weeks of treatment.

Promius Pharma plans to submit additional detailed date from these pivotal phase III studies for presentation at scientific meetings and submit manuscripts for publication in peer reviewed journals in 2015 and 2016. Findings were presented at the 2015 Fall Clinical Dermatology Conference in Las Vegas this month.