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Foamix Initiates Phase II Study on Acne Combination Foam

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Foamix Pharmaceuticals Ltd. announced that the first patient has been enrolled in the phase II study of its topical combination foam, FCD105, comprising minocycline 3% and adapalene 0.3%, for the treatment of moderate-to-severe acne vulgaris. We remind investors that both oral minocycline and topical adapalene products are presently marketed for acne vulgaris in the United States.

While the adapalene 0.3% gel is marketed by Galderma Laboratories’ as Differin, minocycline 3% capsules are marketed under different brand names, like Dynacin, Minocin, and Solodyn. Generic versions of both products are widely available.

The phase II study is expected to enroll about 400 acne vulgaris patients, aged 12 years or older. In the study, patients will be randomized to one of the four treatment arms — FCD105 foam, 0.3% adapalene foam, 3% minocycline foam or vehicle foam and self-application of their assigned treatment once daily — for 12 weeks.

There are three primary endpoints of the study. The first is the proportion of patients achieving success at week 12 based on an Investigator’s Global Assessment. The second is the mean change from baseline in inflammatory lesion counts in each treatment group at week 12. The third is the mean change from baseline in non-inflammatory lesion counts in each treatment group at week 12.

Shares of the company have edged down 0.6% year to date against the industry’s growth of 6.5%.


We remind investors that Foamix has also developed FMX101 (minocycline 4% foam) for the treatment of moderate-to-severe acne vulgaris. The new drug application (NDA) is under FDA review and the agency has set an action date of Oct 20. Another candidate being developed by the company is FMX103 for the treatment of moderate-to-severe papulopustular rosacea.

There are other companies developing treatments for acne as well. Bausch Health’s (BHC - Free Report) acne candidate IDP-123 is under FDA review and a decision is expected on Dec 22. If approved, IDP-123 will be the first tazarotene acne treatment available in a lotion form.


Zacks Rank & Stocks to Consider

Currently, Foamix is a Zacks Rank #3 (Hold) stock.

Some better-ranked stocks in the biotech sector are Dr. Reddy’s Laboratories Ltd. (RDY - Free Report) and Evoke Pharma, Inc. (EVOK - Free Report) . Both companies sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Dr. Reddy’s earnings per share estimates have increased from $1.69 to $2.06 for 2019 and from $2.12 to $2.31 for 2020 in the past 60 days.

Evoke’s loss per share estimates have narrowed from 41 cents to 35 cents for 2019 and from 22 cents to 19 cents for 2020 over the past 60 days.

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