VYNE Therapeutics to Present Results of the Phase 1b Trial for VYN201 at the 2024 Global Vitiligo Foundation Annual Scientific Symposium

Rhea-AI Summary

VYNE Therapeutics announces positive safety and efficacy data for VYN201 in vitiligo treatment, with plans to advance to Phase 2b trial.

Positive

• VYNE Therapeutics reveals positive data from Phase 1b trial of VYN201 in vitiligo treatment.
• Dr. Iain Stuart to present findings at 2024 Global Vitiligo Foundation Annual Scientific Symposium on March 7, 2024.
• Data supports advancement of VYN201 to Phase 2b trial expected to start next quarter.

Negative

• None.

Medical Research Analyst

The recent announcement from VYNE Therapeutics regarding the positive safety and efficacy data from the Phase 1b trial of VYN201, a novel BET inhibitor for vitiligo, is a significant milestone in the development of new treatments for immuno-inflammatory conditions. This is especially relevant considering the current limited options for vitiligo, which is a chronic skin disorder characterized by loss of pigmentation.

From a medical research perspective, the progression of VYN201 into a Phase 2b trial is a critical step. It suggests that the drug has a favorable safety profile and potential efficacy. The impact on the patient community could be substantial, as positive results in later-stage trials may lead to a new, viable treatment option. Moreover, the use of a topical pan-BD BET inhibitor is notable since it targets the bromodomain and extra-terminal (BET) family of proteins, which are known to regulate gene expression involved in inflammation. This could indicate a broader therapeutic potential for VYN201 beyond vitiligo, potentially addressing a range of inflammatory conditions.

Financial Analyst

The advancement of VYN201 into Phase 2b trials could have financial implications for VYNE Therapeutics. Typically, successful Phase 1b outcomes can lead to increased investor confidence and may positively influence the company's stock price. The market for vitiligo treatments is currently underserved and a successful new entrant could capture significant market share. Furthermore, the development of VYN201 could attract partnership opportunities, licensing deals, or even acquisition interest from larger pharmaceutical companies seeking to expand their dermatology portfolios.

However, investors should remain cautious as clinical trials are inherently risky and a large percentage of drugs fail to make it to market. The costs associated with advancing a drug through clinical trials are substantial and the company will likely need to secure additional funding, which could lead to dilution of existing shares. The long-term financial impact will depend on the drug's continued success in clinical trials, regulatory approval and eventual market adoption.

Dermatology Specialist

Within the field of dermatology, vitiligo is known for its psychological and emotional impact on patients, as well as its visibility and chronic nature. The development of VYN201, therefore, not only represents a potential new therapeutic option but also a significant quality-of-life improvement for individuals with vitiligo. The specificity of BET inhibitors like VYN201 in targeting inflammatory pathways without systemic immunosuppression is particularly promising. This approach could minimize potential side effects commonly associated with systemic treatments and provide a more targeted and safer long-term management strategy for vitiligo.

It is also important to note that the efficacy of VYN201 in producing repigmentation and the durability of such effects will be crucial in determining its clinical value. The dermatology community will be looking forward to the Phase 2b trial results for more comprehensive efficacy data and a better understanding of the drug's potential impact on the standard of care in vitiligo treatment.

• Oral presentation on March 7, 2024 will review positive safety and efficacy data for novel BET inhibitor VYN201
  

BRIDGEWATER, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that Dr. Iain Stuart, Chief Scientific Officer of the Company, will deliver an oral presentation featuring positive data from the Phase 1b trial of VYN201 in vitiligo at the 2024 Global Vitiligo Foundation Annual Scientific Symposium taking place in San Diego on March 7, 2024.

“We are pleased to have this opportunity to present the data from our Phase 1b trial with the vitiligo community at the Global Vitiligo Foundation Annual Scientific Symposium,” said Dr. Iain Stuart, Chief Scientific Officer of VYNE. “The positive clinical data from the Phase 1b trial supports the advancement of VYN201 into a Phase 2b trial that we expect to initiate next quarter.”

Presentation Details:

Meeting:	2024 Global Vitiligo Foundation Annual Scientific Symposium
Title:	A Phase 1 Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of a Topical Pan-BD BET Inhibitor (VYN201) in Subjects with Active Non-Segmental Vitiligo (session #4)
Presenter:	Dr. Iain Stuart, Chief Scientific Officer of VYNE
Date/Time/Location: Presentation:	Thursday, March 7, 2024, 9:06 – 9:18 a.m. PT; Marriott Marquis, San Diego; Room: Rancho Sante Fe
Conference info:	Available here

About Vitiligo
Vitiligo is a chronic autoimmune depigmenting disorder of the skin, characterized by the loss of pigment producing cells known as melanocytes. Vitiligo is the most common depigmenting skin condition, with a prevalence estimated at 0.5-2.0% of the world population.¹ There is currently only one FDA-approved product for the treatment of vitiligo. Nonsegmental vitiligo is the most common type of vitiligo.

About VYN201
VYN201 is a pan-bromodomain BET inhibitor designed to be locally-administered as a “soft” drug to address diseases involving multiple, diverse inflammatory cell signaling pathways, while providing low systemic exposure. In addition to demonstrating clinical proof-of-concept in vitiligo, VYN201 has produced consistent reductions in pro-inflammatory and disease-related biomarkers and improvements in disease severity in several preclinical models (using several different routes of administration).

About the VYN201 Phase 1b Study in Vitiligo
The Phase 1b trial was a 16-week open-label trial assessing the safety, tolerability, pharmacokinetics, and exploratory efficacy of a once-daily topical formulation of VYN201 in 29 patients with active nonsegmental vitiligo in three dose cohorts (0.5%, 1.0% and 2.0% concentrations). On October 30, 2023, VYNE announced that significant clinical improvement was observed in the 1.0% and 2.0% cohorts, with rapid onset of action and a dose-dependent response. Mean percentage reduction in facial vitiligo area scoring index score from baseline after 16 weeks of treatment was 7.5%, 30.2% and 39.0% for the 0.5%, 1.0% and 2.0% cohorts, respectively. VYN201 was generally well tolerated with no clinically relevant treatment emergent adverse events across all dose cohorts.

About BET Inhibitors
BET proteins play a key role in regulating gene transcription via epigenetic interactions (“reading”), and recent research has determined a key role for these proteins in regulating B cell and T cell activation and subsequent inflammatory processes. As epigenetic readers, BET proteins regulate the recruitment of transcriptional factors that are key to the production of several pro-inflammatory cytokines. BET inhibitors have the potential to treat a range of immuno-inflammatory and fibrotic diseases by blocking pro-inflammatory cytokine transcription with additional potential in myeloproliferative neoplastic disorders.

^{1. Rosmarin et al, Lancet (2020);396:110-120.}

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. The Company’s unique and proprietary bromodomain & extra-terminal (BET) domain inhibitors, which comprise its InhiBET™ platform, include a locally administered pan-BD BET inhibitor (VYN201) and an orally available BD2-selective BET inhibitor (VYN202) that were licensed from Tay Therapeutics Limited. 

For more information about VYNE Therapeutics Inc. or its product candidates, visit www.vynetherapeutics.com. 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.

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 related to timing for the initiation of a Phase 2b trial for VYN201 in the second quarter of 2024. 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: VYNE’s ability to successfully develop its product candidates; the timing of commencement of future preclinical studies and clinical trials; VYNE’s ability to complete and receive favorable results in, clinical trials for its product candidates; VYNE’s intentions and its ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; and VYNE’s ability to comply with various regulations applicable to its business. 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, 2022, Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, and VYNE’s other filings from time to time 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.

Investor Relations:

John Fraunces
LifeSci Advisors, LLC
917-355-2395
jfraunces@lifesciadvisors.com

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

What positive data did VYNE Therapeutics announce?

VYNE Therapeutics announced positive safety and efficacy data for VYN201 in vitiligo treatment.

Who will present the findings at the 2024 Global Vitiligo Foundation Annual Scientific Symposium?

Dr. Iain Stuart, Chief Scientific Officer of VYNE Therapeutics, will present the findings at the symposium.

When is the presentation scheduled to take place?

The presentation is scheduled for Thursday, March 7, 2024, from 9:06 to 9:18 a.m. PT.

What is the next step for VYN201 after the Phase 1b trial?

The positive data from the Phase 1b trial supports the advancement of VYN201 into a Phase 2b trial expected to start next quarter.