Foamix Pharmaceuticals Ltd. (FOMX - Free Report) announced positive results from the last of the three phase III study – FX2017-22 – evaluating its lead candidate, FMX101, for treating moderate-to-severe acne. The candidate met both the co-primary endpoints of the study. The data showed that treatment with FMX101 led to impressive reductions in inflammatory lesions with a significant proportion of subjects achieving treatment success. The company will share further data from this study over the remainder of 2018.
Shares of the company rallied 56.9% in after-hours trading on Sep 11 following the news. Foamix’s shares have lost 1.5% this year so far compared with the industry’s decline of 0.1%.
The third phase III study evaluated the candidate for absolute change in inflammatory lesion count from baseline at Week 12 and Investigator Global Assessment (“IGA”) treatment success at Week 12 in patients with moderate-to-severe acne. The IGA treatment success was defined by an IGA score of 0 or 1 and at least a 2-grade improvement (decrease) from baseline.
Data showed that patients treated with FXM101 achieved a reduction of 16.93 in inflammatory lesion count at Week 12 from baseline. Moreover, 30.8% of patients achieved IGA treatment success at Week 12.
The safety profile of FMX101 was consistent with what was achieved in the previously completed two phase III studies.
With no approved drugs in its portfolio, the successful completion of the late-stage studies on Foamix’s most advanced pipeline candidate is impressive for the company. Moreover, with the completion of the third phase III study, the company will focus on filing a new drug application seeking approval for FMX101. A potential approval will be a major boost for the company as it is likely to generate a steady revenue stream. Per the press release, approximately 10 million people are affected by moderate-to-severe acne in the United States, which suggests a significant opportunity.
However, there are several companies developing treatments for this indication. We remind investors that Allergan (AGN - Free Report) /Paratek Pharmaceuticals’ (PRTK - Free Report) acne candidate, Seysara is under review in the United States with a decision expected in 2018. In August, the FDA approved Bausch Health Companies Inc.’s (BHC - Free Report) Altreno for the topical treatment of acne vulgaris.
Foamix is also developing its second pipeline candidate, FMX103, in a phase II study for the treatment of moderate-to-severe papulopustular rosacea (bumps and pimples).
Foamix currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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