Israeli-based specialist pharmaceutical firm Foamix Pharmaceutical is set to initiate a third Phase III clinical trial in the US to investigate FMX101 for the treatment of moderate-to-severe acne.
The additional Phase III trial will be based on the results obtained from two prior Phase III 04 and 05 trials.
FMX101 is a 4% minocycline foam being developed for the treatment of moderate-to-severe acne.
The third Phase III trial will evaluate FMX101 for a period of 12 weeks in approximately 1,500 patients at 80 clinical sites.
The co-primary efficacy endpoints are mean change of inflammatory lesion count from baseline and proportion of patients with improvement.
Foamix chief executive officer Dov Tamarkin said: "Based on our analysis of the efficacy results from Trials 04 and 05, we plan to conduct a third trial to validate the results, with the same co-primary endpoints and enrolment criteria but with a substantially increased sample size.
"We intend to begin enrolling patients in this third trial mid-year."
The top-line results from the prior double-blind, randomised, placebo-controlled Phase III trials were found to be favourable.
Conducted in a total of 961 patients over 12 weeks, the trials showed that FMX101 was safe and well tolerated, with no drug-related serious adverse events.
The co-primary endpoints of the trials were similar to that of the third trial, while the secondary endpoints included measure of decrease in non-inflammatory lesion count at week 12 and percentage changes in the inflammatory lesion count at weeks three, six, nine and 12.
Foamix plans to submit a new drug application (NDA) for FMX101 in the second half of next year, based on the results from the third Phase III trial.
