VYNE Therapeutics Completes Enrollment in Phase 2b Trial Evaluating VYN201 for the Treatment of Nonsegmental Vitiligo

• Once-daily VYN201 gel being evaluated in subjects with nonsegmental vitiligo
• Top-line data from the 24-week double-blind portion of the trial expected in mid-2025
• “Repibresib” approved as the non-proprietary name for VYN201 by USAN
  
  

BRIDGEWATER, N.J., Jan. 06, 2025 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, today announced completion of enrollment in the Phase 2b trial evaluating VYN201 gel for the treatment of nonsegmental vitiligo. Top-line data from the 24-week vehicle-controlled treatment period are expected in mid-2025.

“We are pleased to have recently completed enrollment in our Phase 2b trial evaluating VYN201 for the treatment of vitiligo, which marks an important milestone for the program and reflects the continued strong execution of our clinical team,” said David Domzalski, President and Chief Executive Officer of VYNE. “We believe VYN201 gel has the potential to become a differentiated therapy for patients with vitiligo, and we look forward to reporting top-line data from this Phase 2b trial in the middle of this year.”

Additionally, the United States Adopted Names (USAN) Council has adopted “repibresib” as the non-proprietary name for the new chemical entity in VYN201. VYNE will use the name repibresib in public statements, at conferences and other forums, and in corporate-related materials as the Company continues to advance the clinical development of the product.

About the Phase 2b Trial for Repibresib Gel (NCT06493578)

The  is a randomized, double-blind, vehicle-controlled trial evaluating the efficacy, safety and pharmacokinetics of once-daily repibresib gel in three dose cohorts (1%, 2% and 3% concentrations) compared to vehicle for 24 weeks in subjects with active or stable nonsegmental vitiligo. Subjects have been randomized equally (1:1:1:1 ratio) across the active drug cohorts or vehicle (~45 subjects in each arm). Following the 24-week treatment period, subjects who have been randomized in the 1%, 2% and 3% cohorts will have the option to continue treatment with their respective dose concentrations for an additional 28-week extension. Subjects who have been randomized in the vehicle group during the initial 24-week treatment period will be equally re-randomized into one of the three active dose cohorts for an additional 28 weeks.

The primary efficacy endpoint of the trial is the proportion of subjects achieving an improvement in Facial Vitiligo Area Scoring Index of at least 50% from baseline (F-VASI50) at week 24 compared to vehicle, with additional secondary endpoints including F-VASI and Total VASI (T-VASI) at weeks 24 and 52.

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. There is currently only one FDA-approved product for the treatment of vitiligo. Nonsegmental vitiligo is the most common type of vitiligo.

About Repibresib

Repibresib 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, repibresib 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 BET Inhibitors

BET proteins play a key role in regulating gene transcription via epigenetic interactions (“reading”). Recent research has identified a key role for these proteins in regulating activation of immune cells, including T cells and B cells, and subsequent inflammatory and fibrotic 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.

About VYNE Therapeutics Inc.

VYNE is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need. VYNE’s unique and proprietary BET inhibitors, which comprise its InhiBET™ platform, are designed to overcome limitations of early generation BET inhibitors by leveraging alternative routes of administration and enhanced selectivity. 

For more information about VYNE Therapeutics Inc. or its product candidates, visit . 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 (“SEC”), 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 VYNE’s ability to successfully complete the Phase 2b trial evaluating repibresib gel for the treatment of nonsegmental vitiligo, as well as the timing of results in mid-2025, and the potential benefits of repibresib. 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 enroll patients in its clinical trials and successfully develop its product candidates; VYNE’s ability to complete and receive favorable results from clinical trials of its product candidates; VYNE’s 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, 2023 and VYNE’s other filings from time to time with the SEC. 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.

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