Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These companies spend a significant amount in advancing their pipelines. One such biopharma company is Anacor Pharmaceuticals Inc. whose pipeline includes candidates like tavaborole and AN2728.
Recently, Anacor successfully completed an end-of-phase II meeting with the U.S. Food and Drug Administration (FDA) regarding its atopic dermatitis candidate, AN2728.
Anacor reached an agreement with the FDA on all major parameters for the phase III trials. As a result, Anacor will commence a phase III study on AN2728 within two months. The phase III trials will 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.
The phase III study design is based on four prior studies of AN2728 in mild-to-moderate atopic dermatitis – AD-202, AD-203, AD-204 and AD-102 (MUSE study). In all these studies, AN2728 was generally considered to be safe and well-tolerated.
Anacor carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the biopharma sector may consider companies like Gilead Sciences Inc. (GILD - Analyst Report) , Shire plc (SHPG - Analyst Report) and Alkermes plc (ALKS - Analyst Report) , all of which carry a Zacks Rank #1 (Strong Buy).