Foamix Pharmaceuticals is launching an additional Phase 3 trial for FMX101, a topical minocycline treatment for moderate to severe acne.
If the results are positive, this new Phase 3 trial is expected to form the basis for a New Drug Application (NDA) which the company plans to submit in the second half of 2018.
Foamix previously announced topline data from two double-blind, randomized, placebo-controlled Phase 3 trials (Trials 04 and 05) that had investigated FMX101in a total of 961 patients with moderate-to-severe acne. Patients had been treated with either FMX101 (minocycline foam 4%) or vehicle foam once daily over 12 weeks. The results of the co-primary endpoints (absolute change in the number of inflammatory lesions and the proportion of patients achieving investigator global assessment (IGA) success at week 12) for trials 04 and 05 were presented separately.
A new analysis reflects the pooled data results for the co-primary endpoints from the two trials and data from secondary efficacy endpoint analyses -- reduction of non-inflammatory lesion count at week 12, and percent changes in inflammatory lesion count at week 3, 6, 9 and 12.
As previously announced, FMX101 was generally safe and well tolerated with no drug-related serious adverse events identified.
Co-primary endpoint - Absolute change from baseline in inflammatory lesion count at week 12:
· Trial 04: reduction of 14.16 lesions (or -14.16) for FMX101 and reduction of 11.17 lesions (or -11.17) for the vehicle (p<0.01)
· Trial 05: -13.46 for FMX101 and -10.72 for vehicle (p<0.01)
· Pooled Analysis: Absolute change in inflammatory lesion count was -13.79 for the FMX101, 4% treatment group and -10.94 for vehicle (p=0.0001)
Co-primary endpoint - Proportion of patients with Investigator's Global Assessment (IGA) success at week 12:
· Trial 04: IGA treatment success for FMX101, 4% treatment group was 8.09% versus 4.77% in vehicle (p=0.2178)
· Trial 05: IGA treatment success for FMX101, 4% treatment group was 14.67% versus 7.89% in vehicle (p<0.05)
· Pooled Analysis: IGA treatment success was 11.51% for FMX101, 4% treatment group and 6.34% for vehicle (p<0.05)
Additional Phase 3 Analyses – Results Statistically Significant for Secondary Efficacy Endpoints
Secondary efficacy endpoint - Percent change from baseline in inflammatory lesion count at weeks 3, 6, 9 and 12:
· Trial 04: reduction of 29% for FMX101 vs. reduction of 19% for vehicle, or -29% vs. -19%, at week 3 (p<.001); -37% vs. -26% at week 6 (p<.001); -42% vs. -28% at week 9 (p<.0001); and -44% vs. -34% at week 12 (p<0.01)
· Trial 05: reduction of 34% for FMX101 vs. reduction of 21% for vehicle, or -34% vs. -21%, at week 3 (p<.0001); -39% vs. -27% at week 6 (p<.0001); -43% vs. -31% at week 9 (p<.001); and: -43% vs. -34% at week 12 (p<0.01)
Secondary efficacy endpoint – Absolute change from baseline in non-inflammatory lesion count at week 12
· Trial 04: reduction of 16.45 lesions (or -16.45) for the FMX101, 4% treatment group and reduction of 10.30 lesions (or -10.30) for the vehicle (p<0.01)
· Trial 05: -13.20 for the FMX101, 4% treatment group and -7.00 for the vehicle (p<0.05)
· Pooled Analysis: Absolute change in non-inflammatory lesion count was -14.76 for the FMX101, 4% treatment group and -8.64 for vehicle (p<0.01)
To achieve the necessary statistical power, compared with the prior Phase 3 trials, the target patient enrollment number has been increased to 1,500. Patients will be randomized 1:1 to receive either FMX101 (minocycline foam 4%) or vehicle foam once daily over 12 weeks. The co-primary efficacy endpoints will be identical to the prior Phase 3 trials: 1) mean change from baseline in the inflammatory lesion count, and 2) proportion of patients with IGA scores of "Clear" or "Almost Clear", with improvement of at least two grades from baseline. The inclusion criteria will be consistent with the prior Phase 3 trials. The trial is planned to be conducted at approximately 80 clinical sites in the U.S.
In related news, Foamix is also developing FMX103, minocycline foam 1.5%, a topical foam formulation of minocycline for the treatment of moderate-to-severe papulopustular rosacea. Based on the outcome of the Phase 3 studies for FMX101 and the increase in the number of patient to be enrolled to the third Phase 3 trial in acne, the company has also increased the sample size for the two planned Phase 3 studies for FMX103 in papulopustular rosacea. The sample size is being increased from 600 patients per trial to 750 patients per trial, for a total of 1500 patients across the two trials. As previously communicated, the company intends to commence the Phase 3 studies for FMX103 mid-year 2017.