Foamix Pharmaceuticals has reported positive top-line results from the Phase III programme of FMX103 1.5% minocycline foam being assessed for moderate-to-severe papulopustular rosacea.
The FX2016-11 and FX2016-12 clinical trials met co-primary endpoints of absolute change in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success at week 12 from baseline.
In the FX2016-11 trial, mean inflammatory lesion count at baseline was 28.5 for FMX103 foam, and the proportion of patients with an IGA score of three or four was 89.7% and 10.3% respectively.
The mean lesion count at baseline was 30 in the FX2016-12 study, while patients with an IGA score of three or four was 86.2% and 13.8% respectively.
Compared to the vehicle foam, FMX103 was found to have achieved statistically significant improvement in subject disease severity across all cases.
Data also showed a favourable safety profile for the investigational candidate. The most commonly reported adverse event in both Phase III trials was upper respiratory tract infection.
Foamix Pharmaceuticals CEO David Domzalski said: “FMX103 has the potential to address significant unmet medical needs in papulopustular rosacea.
“This product leverages our proprietary foam technology, and we believe if FMX103 is approved it would be the first topical minocycline product available for rosacea patients.
FX2016-11 and FX2016-12 are double-blind, randomised, vehicle-controlled trials conducted to evaluate once-daily FMX103 minocycline foam over 12 weeks in a total of 1,522 subjects across 100 sites in the US.
Foamix concluded dosing patients in these trials in June.
The Phase III programme also includes an FX2016-13 study designed to investigate the long-term safety of FMX103. Results from this trial are expected to be available in the first half of next year.