Foamix has mixed results in Phase 3 acne med trial
Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX), today announced the topline results of its two Phase 3 clinical trials investigating FMX101, Trial 04 and Trial 05, in patients with moderate-to-severe acne.
In the intent-to-treat analysis, FMX101 demonstrated statistical significance compared to vehicle on both co-primary endpoints in Trial 05, but did not demonstrate statistical significance on one of the two co-primary endpoints in Trial 04, specifically IGA success.
Key top-line data:
- Co-primary endpoint – Absolute changes from baseline in the number of inflammatory lesions
· Trial 04: -14.16 for FMX101 and -11.17 for the vehicle (p=0.0071); percent reductions were 43.93% for FMX101 and 34.03% for the vehicle (p<0.01)
· Trial 05: -13.46 for FMX101 and -10.72 for vehicle (p=0.0058); percent reductions were 42.94% for FMX101 and 33.94% for vehicle in Trial 05 (p<0.01)
- Co-primary endpoint – Proportions of patients with Investigator’s Global Assessment (IGA) success
· Trial 04: 8.09% for FMX101 and 4.77% for the vehicle (p=0.2178)
· Trial 05: 14.67% for FMX101 and 7.89% for the vehicle (p=0.0423)
- FMX101 was generally safe and well-tolerated.
“Whereas Trial 05 showed significance in both primary endpoints, Trial 04 did not meet significance for the IGA score endpoint,” said Dov Tamarkin, Ph.D., CEO of Foamix. “Our team has not yet received the full data set and we intend to provide an update on the program as soon as we complete our analysis. As we have previously announced, the safety extensions for trials 04 and 05 are fully enrolled and continue as planned.”
The two double-blind, randomized, placebo-controlled Phase 3 trials (Trials No. 04 and 05) included a total of 961 subjects with moderate-to-severe acne. Subjects were randomized to receive either FMX101 (minocycline foam 4%) or vehicle foam once daily over 12 weeks.
The two co-primary endpoints were the absolute change in the number of inflammatory lesions (papules and pustules); and the proportion of patients achieving success at week 12, as defined by an IGA score of “clear” or “almost clear” and at least a two-grade improvement from baseline at week 12.
As stated in our recent earnings call, as of Dec. 31, 2016, Foamix had cash and investments of $131 million. We expect our cash and investments to fund our operations into mid-2019 including the continued development of our pipeline.
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