Foamix Pharmaceuticals has commenced patient dosing in a Phase III clinical trial (FX2017-22) of its product candidate FMX101 in patients with moderate-to-severe acne.
FMX101 is a topical drug candidate with 4% minocycline foam being developed for the treatment of acne.
The double-blind, vehicle-controlled, multi-centre Phase III trial will evaluate once-daily FMX101 in 1,500 patients over 12 weeks at approximately 80 clinical centres across the US.
Foamix Pharmaceuticals CEO David Domzalski said: "During a recent type B meeting, the US Food and Drug Administration (FDA) confirmed that statistically significant findings from a third study would constitute replication of the study FX2014-05 results, and would be sufficient to establish an efficacy claim.
“This confirmation supports our plans for conducting a third Phase III study.”
The primary endpoints of the trial are the proportion of patients reporting success at week 12 as indicated by an investigator's global assessment and mean change in inflammatory lesion counts from baseline at week 12.
Additionally, the trial will assess the safety of the product candidate through reported adverse events, tolerability, clinical laboratory tests and vital signs.
Top-line results from the Phase III trial are expected to be available by mid next year.
Foamix is also planning to conduct a parallel, long-term, open-label safety extension study to investigate the safety of intermittent use of FMX101. The extension study is estimated to be completed by the end of this year.