Anacor Pharmaceuticals, Inc. enrolled the first patient in a phase III study on its atopic dermatitis candidate, AN2728, for the topical treatment of mild-to-moderate atopic dermatitis.
The phase III trials comprise two multi-center, double-blind, randomized (2:1), placebo-controlled studies enrolling roughly 750 patients (two years and above) each.
An Investigator Static Global Assessment (ISGA) is a 5-point scale from 0 (clear) to 4 (severe). An ISGA score of 2 or 3 represents mild-to-moderate atopic dermatitis. The primary endpoint is to achieve an ISGA score of 0 or 1 with at least a 2-grade improvement from baseline on Day 29. Secondary endpoints include achieving an ISGA score of 0 or 1 at Day 29 along with the time to treatment success.
A long-term safety study will also be conducted by Anacor to evaluate the safety of intermittent use of AN2728 for a period of 12 months. Patients who complete either of the two phase III studies may enroll in this study.
We note that Anacor expects a response regarding its most advanced candidate Kerydin for the treatment of onychomycosis to be out by Jul 29, 2014. Anacor intends to launch Kerydin in the second half of 2014 assuming U.S. Food and Drug Administration approval.
Anacor carries a Zacks Rank #3 (Hold). We are encouraged by the pipeline progress at Anacor. However, the atopic dermatitis market is crowded with drugs like Elidel and Protopic. We also note that Sanofi (SNY - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) are evaluating dupilumab for treating patients suffering from moderate-to-severe atopic dermatitis.
Investors looking for better-ranked stocks may consider a Zacks Rank #1 (Strong Buy) company like Shire (SHPG - Free Report) .