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ARTICLE | Clinical News

Foamix's minocycline foam meets in third Phase III for acne

September 14, 2018 5:27 PM UTC

Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX) reported on Sept. 11 that FMX101 met the co-primary endpoints in the Phase III FX2017-22 trial to treat moderate to severe acne. By year end, the company plans to submit an NDA to FDA for FMX101 through the agency's 505(b)(2) pathway. The candidate is a topical 4% minocycline foam, a semisynthetic derivative of tetracycline.

The double-blind, U.S. trial enrolled 1,507 patients to receive once-daily FMX101 or vehicle foam for 12 weeks. On the first co-primary endpoint, FMX101 significantly reduced mean inflammatory lesion count from baseline to week 12 by 16.93 lesions vs. 13.4 lesions for vehicle (p<0.0001). On the other co-primary endpoint, 30.8% of patients who received FMX101 achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 with a ≥2-grade improvement from baseline to week 12 vs. 19.6% of patients who received vehicle (p<0.0001)...

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