VYNE Therapeutics Reports Successful End-of-Phase 2 Meeting with the FDA for FCD105 in Acne

About this update from Vyne Therapeutics Inc.

[{"type":"text","content":"Company on track to initiate the TRILOGY Phase 3 program in 2021\nBRIDGEWATER, N.J., Dec. 17, 2020 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) , a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA). The Company, in consultation with the FDA, has established the key elements of the Phase 3 program to support a New Drug Application (NDA) for FCD105 (3% minocycline / 0.3% adapalene foam), the first ever minocycline-based combination product, for the treatment of moderate-to-severe acne vulgaris. The End-of-Phase 2 meeting was supported by non-clinical safety, CMC and clinical information, including results from the previously completed positive Phase 2 study evaluating FCD105 in patients with moderate-to-severe acne vulgaris. In the Phase 2 study, FCD105 demonstrated potentially class-leading efficacy on the co-primary outcome measures of (1) Investigator’s Global Assessment (IGA) treatment success (IGA score “0” or “1” and at least a two-grade improvement from baseline) and (2) absolute change from baseline in mean inflammatory counts at Week 12. The most commonly reported treatment-emergent adverse event in the trial was upper respiratory tract infection (4.9% in the vehicle treatment group) with dry skin being the most commonly reported cutaneous adverse event (3.6% in the 0.3% adapalene treatment group). The majority of adverse events were assessed as mild in severity. There were no serious adverse events. . The meeting provided VYNE with clear direction on the Phase 3 clinical and pharmaceutical development plans for FCD105 and, should the clinical studies meet their objectives, the meeting provided further clarity on preparations required for the anticipated NDA. Specifically, key outcomes from the meeting included: Agreement with FDA to conduct two, identical,12-week, double-blind Phase 3 efficacy and safety studies (TRILOGY-1 and TRILOGY-2). Each study will enroll 550 subjects aged 9 years and older with a clinical diagnosis of moderate-to-severe acne vulgaris. Subjects will be randomized 2:1 to received either FCD105 or vehicle respectively.Agreement to conduct one, 40-week open-la...

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