Business
VYNE Therapeutics Announces its China Partner’s Enrollment of First Patient in Phase 3 Study of AMZEEQ® in Patients with Moderate to Severe Acne
BRIDGEWATER, N.J., Oct. 05, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that the first patient
About this update from Vyne Therapeutics Inc.
[{"type":"text","content":"BRIDGEWATER, N.J., Oct. 05, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that the first patient has been enrolled in a Phase 3 study in China evaluating AMZEEQ® (minocycline) topical foam, 4% in moderate to severe acne. The study is being conducted by the Company’s partner, Cutia Therapeutics (“Cutia”), for the purposes of seeking regulatory approval for AMZEEQ in China. “We are pleased that Cutia has reached this important clinical development milestone for AMZEEQ and look forward to the continued progress in securing regulatory approval of AMZEEQ in China,” said David Domzalski, President and Chief Executive Officer of VYNE. “Our license agreement with Cutia extends our commercial reach outside the U.S. and, if approved, makes AMZEEQ available to the hundreds of millions of patients in China suffering from acne.” The study is a multicenter, randomized, double-blind, vehicle-controlled Phase III study to evaluate the efficacy and safety of topical administration of minocycline topical foam, 4% in the treatment of moderate-to-severe acne vulgaris. It is expected to enroll 372 patients at approximately 29 sites in China. The primary endpoint for the study is the absolute change from baseline in inflammatory lesion count at Week 12, while a key secondary endpoint is IGA endpoint success at Week 12, where success is defined as an IGA score of 0 or 1 (clear or almost clear), and at least a 2-grade improvement (decrease) from baseline. In April 2020, VYNE entered into a licensing agreement with an affiliate of Cutia Therapeutics, a dermatology-focused company based in Shanghai, China. Under the terms of the agreement, Cutia has an exclusive license to obtain regulatory approval of and commercialize AMZEEQ, ZILXI and its FCD105 product candidate, once approved, in greater China. The Company is eligible to receive royalties on net sales of any licensed products. About VYNE Therapeutics Inc.VYNE’s mission is to improve the lives of patients by developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions. With expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of therapies for major immuno-inflammatory conditions and rare skin diseases with high unmet medical ne...