- Oral, once-daily doses of VYN202 being evaluated in subjects with moderate-to-severe plaque psoriasis
- Top-line data from the 12-week double-blind trial expected by year-end 2025
- Phase 1b trial designed to provide key insights into VYN202's potential across a range of chronic, immune-mediated diseases
BRIDGEWATER, N.J., Feb. 19, 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 that the first subject has been dosed in a Phase 1b trial evaluating VYN202 in moderate-to-severe plaque psoriasis. VYN202 is an oral small molecule BD2-selective bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immune-mediated diseases. The Phase 1b trial will primarily evaluate the safety of VYN202, administered orally once a day for 12 weeks, with secondary objectives to evaluate the pharmacokinetic profile and preliminary evidence of efficacy, including improvement from baseline in psoriasis area and severity index (PASI) scores. Top-line data from the 12-week randomized, placebo-controlled trial are expected by year-end 2025.
"The initiation of the Phase 1b trial in subjects with moderate-to-severe plaque psoriasis represents a major step forward in advancing our novel and highly selective oral BET inhibitor, VYN202," said David Domzalski, President and Chief Executive Officer of VYNE. "Psoriasis shares common underlying biological pathways with several other chronic inflammatory conditions, and we believe results from this trial will provide key insights into VYN202's potential use as a novel, once-daily oral treatment for chronic immune-mediated diseases."
"Our Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) trial showed that VYN202 had a favorable safety profile and also demonstrated VYN202's potential to inhibit the production of multiple inflammatory biomarkers related to Th17, TNF and Th1/myeloid dysregulated activity," said Iain Stuart, PhD, Chief Scientific Officer of VYNE. "We look forward to reporting results from this robust Phase 1b trial by the end of this year."
About the Phase 1b Trial for VYN202
The Phase 1b trial is a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability and pharmacokinetics of once-daily VYN202 in three dosing cohorts (0.25 mg, 0.5 mg, 1 mg doses), compared to placebo, for 12 weeks in subjects with moderate-to-severe plaque psoriasis. Exploratory efficacy of VYN202 will also be evaluated including measures of PASI, Static Physician Global Assessment (sPGA), scalp disease, quality of life, and biomarker analyses. Subjects will be randomized equally (1:1:1:1 ratio) across the active drug cohorts or placebo (~20 subjects in each arm). Following the 12-week treatment period, all subjects will be followed for a 4-week safety period.
About Plaque Psoriasis
Plaque psoriasis is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.1 It is estimated that eight million Americans and more than 125 million people worldwide live with the disease.2 Plaque psoriasis is believed to share common inflammatory pathways involving IL-23/IL-17, TNF, among others, which drive other chronic immune mediated diseases such as psoriatic arthritis (PsA), hidradenitis suppurativa (HS), inflammatory bowel disease (IBD), and axial spondyloarthritis (AxSpA).
About VYN202
VYN202 is an innovative, oral small molecule BET inhibitor that has potential class-leading selectivity and potency for BD2 vs. BD1. By maximizing BD2 selectivity, VYNE believes VYN202 has the potential to be a differentiated, more conveniently administered, non-biologic treatment option for both acute control and chronic management of immuno-inflammatory indications, in which the damaging effects of unrestricted inflammatory signaling activity are common.
About BET Inhibitors
BET proteins play a key role in regulating gene transcription via epigenetic interactions ("reading") in the nucleus of the cell. 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.
1 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed January 2025.
2 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed January 2025.
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 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 ("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 statements regarding the clinical development of VYNE's product candidates, including VYN202, the timing of results from VYNE's Phase 1b trial, and the potential benefits of VYNE's product candidates, including VYN202. 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: 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 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 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.
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