Israel’s Foamix Pharmaceuticals showed its 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.