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
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,
), 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
A long-term safety study will also be conducted by Anacor to
evaluate the safety of intermittent use of AN2728 for a period of
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
Gilead Sciences Inc.
), all of which carry a Zacks Rank #1 (Strong Buy).
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