Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX) rose soon after Wednesday’s opening bell, after the company disclosed that its Phase 3 program evaluating FMX103 topical minocycline foam for moderate-to-severe papulopustular rosacea met both co-primary endpoints.
The clinical stage pharmaceutical company, with U.S. headquarters in Bridgewater, New Jersey, reported that studies FX2016-11 and FX2016-12 met both co-primary endpoints of (1) absolute change from baseline in inflammatory lesion count at Week 12, and (2) Investigator Global Assessment ("IGA") treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline.
The safety profile of FMX103 was found to be favorable. Data from study FX2016-13 evaluating the long-term safety of FMX103 are expected to be reported in the first half of 2019.
Said CEO David Domzalski, "We are very pleased with these top line Phase 3 results of FMX103, which demonstrate that FMX103 can provide a meaningful improvement in disease symptoms and confirm the positive results from previous clinical studies.
"FMX103 has the potential to address significant unmet medical needs in papulopustular rosacea."
These identical, double-blind, randomized, vehicle-controlled Phase 3 studies enrolled a total of 1522 subjects, 18 years of age and older, with moderate-to-severe papulopustular rosacea at 100 sites in the United States (FX2016-11 enrollment: 751 subjects, FX2016-12 enrollment: 771 subjects).
Patients were randomized 2:1 to receive either FMX103 minocycline foam (1.5%) or vehicle foam once daily for 12 weeks, respectively.
Shares took on 16 cents, or 3.6%, to $4.64
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