VYNE Therapeutics Announces its China Partner’s Enrollment of First Patient in Phase 3 Study of AMZEEQ® in Patients with Moderate to Severe Acne

Rhea-AI Summary

VYNE Therapeutics has announced the enrollment of the first patient in a Phase 3 study in China for AMZEEQ® (minocycline) topical foam, 4%, targeting moderate to severe acne. Conducted by Cutia Therapeutics, this study aims to secure regulatory approval for the product in China, expanding VYNE’s market reach. The study will enroll 372 patients across 29 sites, with the primary endpoint measuring changes in inflammatory lesion counts at Week 12. VYNE's licensing agreement with Cutia positions the company to earn royalties on net sales of AMZEEQ.

Positive

• First patient enrolled in Phase 3 study for AMZEEQ in China.
• Study could lead to regulatory approval and expanded market reach.
• Potential royalties on net sales if AMZEEQ is approved.

Negative

• None.

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 need. The Company’s unique and proprietary pipeline includes Phase 3 ready FCD105 (3% minocycline and 0.3% adapalene) for the treatment of moderate-to-severe acne vulgaris, FMX114 for the treatment of mild-to-moderate atopic dermatitis and a library of bromodomain & extra-terminal domain inhibitors in both topical and oral forms for the treatment of major immuno-inflammatory conditions and rare skin diseases. VYNE 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.

Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
646-889-1200
jallaire@lifesciadvisors.com

Tyler Zeronda
VYNE Therapeutics Inc.
908-458-9106
Tyler.Zeronda@VYNEtx.com

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 by VYNE or any of its licensing partners 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 and liquidity, including our ability to progress a preclinical or clinical trial; adverse events associated with the development and commercialization of our product candidates and approved products; the outcome and cost of pre-clinical and clinical trials for current and future product candidates; determination by regulatory authorities that results from VYNE’s or its partner’s pre-clinical and clinical trials are not sufficient to support registration or marketing approval of product candidates; the eligible patient base and commercial potential of AMZEEQ, ZILXI or any of VYNE’s other products or product candidates; risks of potential litigation by third-parties regarding infringement of third-party intellectual property; 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; volatility in our stock price may result in rapid and substantial increases or decreases in our stock price that may or may not be related to our operating performance or prospects; 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 Annual Report on Form 10-K for the year ended December 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.

FAQ

What is the purpose of the Phase 3 study for VYNE's AMZEEQ?

The Phase 3 study aims to evaluate the efficacy and safety of AMZEEQ in treating moderate to severe acne in China.

How many patients will be enrolled in the Phase 3 study for AMZEEQ?

The study is expected to enroll 372 patients across approximately 29 sites in China.

When was the first patient enrolled in the AMZEEQ Phase 3 study?

The first patient was enrolled on October 5, 2021.

What are the primary endpoints of the AMZEEQ Phase 3 study?

The primary endpoint is the absolute change from baseline in inflammatory lesion count at Week 12.

What potential market impact could AMZEEQ have if approved in China?

If approved, AMZEEQ could reach hundreds of millions of patients in China suffering from acne, significantly expanding VYNE's market presence.