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Nov 07, 2018
 |  BC Extra  |  Clinical News

Foamix planning NDA for minocycline foam to treat rosacea

Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX) plans to submit an NDA to FDA next year for FMX103 to treat moderate to severe papulopustular rosacea after the product met the co-primary endpoints in a pair of Phase III trials in the indication. FMX103 is a topical 1.5% foam formulation of minocycline, a semisynthetic derivative of tetracycline.

The double-blind, U.S. FX2016-11 and FX2016-12 trials enrolled 751 and 771 patients, respectively, to receive once-daily FMX103 or vehicle foam for 12 weeks. On the first co-primary endpoint in FX2016-11, FMX103 significantly reduced mean inflammatory lesion count from baseline to week 12 by 17.57 lesions vs. 15.65 lesions for vehicle (p=0.0031). On the other co-primary endpoint, 52.1% of patients who received FMX103 achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 with a ≥2-grade improvement from baseline to week 12 vs. 43% of patients who received vehicle (p=0.027).

In FX2016-12, FMX103 significantly reduced mean inflammatory lesion count from baseline to week 12 by 18.54 lesions vs. 14.88 lesions for vehicle (p<0.0001). Additionally, 49.1% of patients who received FMX103 achieved an IGA score of 0 or 1 with a ≥2-grade improvement from baseline to week 12 vs. 39% of patients who received vehicle (p=0.0077).

FMX103 was generally well tolerated with no treatment-related serious adverse events reported. Foamix plans to report long-term safety data next half from the Phase III FX2016-13 trial of FMX103 to treat rosacea.

In September, Foamix reported that its topical 4% minocycline foam, FMX101, met the co-primary endpoints in a Phase III trial to treat moderate to severe acne. The company plans to submit an NDA to FDA this year for FMX101 through the agency's 505(b)(2) pathway (see “Foamix Raises $70M Following Phase III Acne Readout”).

Foamix was up $0.11 to $4.59 on Wednesday.

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