Foamix Announces Positive Topline Results from Third Phase 3 Trial (Study FX2017-22) Evaluating FMX101 Topical Minocycline Foam for Moderate-to-Severe Acne
FMX101 Demonstrated Highly Statistically Significant Improvement Compared with Vehicle in Both Co-Primary Efficacy Endpoints
REHOVOT, Israel and BRIDGEWATER, N.J., Sept. 11, 2018 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX), ("Foamix"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced the topline results of its third Phase 3 clinical trial (FX2017-22) of FMX101 for the treatment of moderate-to-severe acne. The study met both co-primary endpoints of (1) absolute change from baseline in inflammatory lesion count at Week 12, and (2) Investigator Global Assessment ("IGA") treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline. The safety profile of FMX101 was found to be consistent with that determined from the two prior Phase 3 studies (FX2014-04 and FX2014-05). Foamix plans to continue to share data from this study as they become available over the remainder of 2018.
"We are extremely pleased with the topline results of this confirmatory Phase 3 trial. These study results should support a finding that FMX101 appears to be safe and effective in the treatment of moderate-to-severe acne," said David Domzalski, CEO of Foamix. "This is the most significant milestone to date for Foamix and brings us closer to helping patients who struggle with the physical and psycho-social effects of acne. If approved, we believe FMX101 would be the first topical minocycline product available for patients in the United States."
Mr. Domzalski further stated, "On behalf of Foamix, I wish to thank all patients, caregivers/guardians, investigators and support staff who participated in the advancement of this clinical program. With the conclusion of this third study, we are now in position to finalize our efforts to submit the company's first NDA."
"The data from this confirmatory Phase 3 study are impressive, and the reductions in inflammatory lesions and the proportions of subjects achieving treatment success highlight significant improvements in disease severity for those that received FMX101 in the study," stated Iain A. Stuart, Ph.D., Senior Vice President, Research & Development, Foamix. "The strong body of clinical data we have generated with FMX101, including the results from this most recent Phase 3 trial, suggest that it may offer patients an efficacious treatment in a convenient and safe topical foam formulation. If approved, it has the potential to address a significant unmet need in this difficult to treat condition."
FX2017-22 Trial Design and Results
The double-blind, randomized, vehicle-controlled Phase 3 trial enrolled 1507 patients with moderate-to-severe acne at 89 sites in the United States. Patients were randomized to receive either FMX101 minocycline foam (4%) or vehicle foam once daily for 12 weeks. The co-primary efficacy endpoints were: (1) the absolute change from baseline in the number of inflammatory lesions, and (2) Investigator Global Assessment (IGA) treatment success, where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline. Safety and tolerability were also evaluated.
Baseline Acne Severity
The mean inflammatory lesion count at baseline was 30.7 and 30.8 for the FMX101 and vehicle treatment groups, respectively. The proportion of subjects with an IGA score of 3 ("moderate") or 4 ("severe") was 84.0% and 16.0%, respectively, in the FMX101 treatment group and 83.5% and 16.5%, respectively, in the vehicle treatment group.
Co-Primary Efficacy Assessments
Significant reduction in the number of inflammatory lesions
The mean reduction in inflammatory lesion count at Week 12 relative to baseline was -16.93 for the FMX101 treatment group and -13.40 for the vehicle treatment group (p<0.0001, ANCOVA, ITT, MI).
Significant improvement in Investigator's Global Assessment (IGA) treatment success
The proportion of subjects that achieved IGA treatment success at Week 12 was 30.80% for the FMX101 treatment group and 19.63% for the vehicle treatment group (p<0.0001, CMH test - stratified by analysis center, ITT, MI).
Safety and Tolerability
The most commonly reported adverse event in the study was (viral) upper respiratory tract infection (6.4% in both FMX101 and vehicle treatment groups). There were no treatment-related serious adverse events. A total of 5 subjects discontinued the study due to an adverse event (3 in the FMX101 treatment group and 2 in the vehicle treatment group). FMX101 appeared to be generally safe and well-tolerated.
