Foamix announces topline results of its two Phase 3 clinical trials investigating FMX101 in patients with moderate-to-severe -- 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:
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
- 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
- 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.
"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."
- As stated in the co's recent earnings call, as of Dec. 31, 2016, Foamix had cash and investments of $131 million. The co expects its cash and investments to fund operations into mid-2019 including the continued development of its pipeline.
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