BRIDGEWATER, 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-label Phase 3 safety study (TRILOGY-3) which will enroll a minimum of 450 subjects from the preceding 12-week double-blind studies. FDA agreed to accept the corresponding data from this study after the NDA has been submitted. It is expected that this will enable the NDA to be submitted earlier than originally planned.
- The Phase 1 dermal safety program was reduced from the customary five studies to two studies comprising a Phase 1 safety/pharmacokinetic “bridging” study under maximum use treatment conditions and a photoallergenicity study. The latter study may not be required, pended further characterization of the product.
- FDA agreed to a much-reduced pharmaceutical development and stability program which is expected to have positive impacts on both overall development cost and commercial product cost of goods, should FCD105 be approved.
“We are pleased with the outcome of our recent End-of-Phase 2 meeting with FDA and the collaborative and productive guidance we received for our program,” said David Domzalski, CEO of VYNE. “Alignment with the FDA on our Phase 3 clinical development plan provides clarity about our development pathway for FCD105 in acne and we look forward to commencing the program next year”.
Acne is a chronic, inflammatory skin condition that affects the skin’s sebaceous glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and truncal areas of the body. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate to severe disease that may impact self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.
About VYNE Therapeutics Inc.
VYNE Therapeutics’ mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.
With expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST™), and has received FDA approval for AMZEEQ® (minocycline) topical foam, 4%, the world’s first topical minocycline, and for ZILXI™ (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea. For more information about our approved products, please see AMZEEQ’s Full Prescribing Information at amzeeq.com and ZILXI’s Full Prescribing Information at zilxi.com.
For more information about VYNE Therapeutics Inc. or its investigational products, visit www. vynetherapeutics.com or follow VYNE on Twitter. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.
LifeSci Advisors, LLC
Chief Financial Officer
Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of VYNE’s products and product candidates and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the COVID-19 pandemic and its impact on our business operations; adverse events associated with the commercialization of AMZEEQ and ZILXI; the outcome and cost of clinical trials for current and future product candidates; determination by the FDA that results from VYNE’s clinical trials are not sufficient to support registration or marketing approval of product candidates; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ, ZILXI or any other products or product candidates that VYNE may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ and ZILXI prescription reimbursement; the eligible patient base and commercial potential of AMZEEQ, ZILXI or any of VYNE’s other products or product candidates; risks that VYNE’s intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of VYNE’s patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE’s patent applications may not be granted and potential competitors may also seek to design around VYNE’s granted patents or patent applications; additional competition in the acne and dermatology markets; risks related to our indebtedness; inability to raise additional capital on favorable terms or at all; VYNE’s ability to recruit and retain key employees; and VYNE’s ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE’s subsequent filings with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.