VYNE Therapeutics Announces Dosing of First Subject in Phase 2b Vitiligo Trial of Novel BET Inhibitor VYN201
VYNE Therapeutics has commenced dosing the first subject in its Phase 2b trial for VYN201, a novel BET inhibitor gel, aimed at treating nonsegmental vitiligo. This 24-week, double-blind, vehicle-controlled study will evaluate the safety and efficacy of once-daily VYN201 gel in three concentrations: 1%, 2%, and 3%. Approximately 160 subjects will be randomized in a 1:1:1:1 ratio. Following the initial treatment period, active treatment subjects will continue for another 28 weeks, while vehicle group subjects will be re-randomized to one of the VYN201 concentrations. The study's primary endpoint is achieving a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24. Top-line data are expected by mid-2025. Early Phase 1b results showed VYN201's rapid clinical response and favorable safety profile, suggesting it could become a differentiated therapy for vitiligo patients.
- First subject dosed in Phase 2b trial, marking progress in VYN201's clinical development.
- Trial includes triple-dosing cohorts (1%, 2%, and 3%) to assess varied efficacy and safety.
- Approximately 160 subjects, ensuring robust data collection.
- 24-week treatment period followed by a 28-week extension for more extended efficacy assessment.
- Primary endpoint focuses on a significant 50% improvement in Facial Vitiligo Area Scoring Index (F-VASI50) at week 24.
- Phase 1b trial showed VYN201's rapid clinical response and favorable safety profile with low systemic exposure.
- Top-line data from the trial will not be available until mid-2025, delaying potential market availability.
- The trial's vehicle-controlled design means that placebo effects could impact perceived efficacy.
- There is a prolonged period (52 weeks) before complete efficacy and safety data are available, which may affect investor confidence.
Insights
VYNE Therapeutics' progress in their Phase 2b trial for VYN201 brings an intriguing dimension to the treatment landscape for vitiligo. The drug's mechanism, as a novel BET inhibitor, aims to modulate gene expression and inflammatory responses, potentially offering a new therapeutic pathway for a condition that currently has limited treatment options. Vitiligo, characterized by the loss of skin pigmentation, affects millions globally and significantly impacts quality of life.
From a clinical standpoint, the trial's design, involving 160 subjects across multiple doses, ensures a robust dataset that can validate earlier findings of safety and efficacy. The primary endpoint, F-VASI50, is a well-recognized measure in vitiligo studies, providing clear insights into the treatment's impact. The inclusion of different concentrations (1%, 2% and 3%) will help determine the most effective and safest dose, offering valuable data for future regulatory submissions.
However, it's important to note that top-line data won't be available until mid-2025, which means investors will need to exercise patience. The ongoing 52-week data collection also introduces potential variability and extended timelines for conclusive outcomes.
For retail investors, the initiation of this trial marks a positive step in VYNE's pipeline development. But it's essential to remain aware of the inherent risks and timelines involved in clinical trials, especially given the competitive nature of the pharmaceutical industry.
VYNE Therapeutics' announcement about the dosing of the first subject in their Phase 2b vitiligo trial signals a significant milestone for the company. This step not only advances their clinical pipeline but also has potential financial implications. If VYN201 proves effective and safe, it could open up a substantial market opportunity. Vitiligo treatments are in demand and a novel, effective therapy could command a considerable market share.
Financially, investors should consider the mid-2025 timeline for top-line data. This extended period means that while the news is promising, it will not immediately translate into revenue or a market performance uptick. Therefore, the stock's movement may largely depend on interim updates or broader market conditions over the next year and a half.
Given the competitive nature of the biopharmaceutical sector, the success of VYN201 would significantly differentiate VYNE from its peers. However, it's important to monitor expenditure associated with the trial and its potential dilutive effects if additional financing becomes necessary. Investors should keep a close eye on quarterly financial statements for signs of strain or prudent cash management.
Trial will evaluate once-daily VYN201 gel in subjects with either active or stable nonsegmental vitiligo
Top-line data from the 24-week double-blind portion of the trial expected in mid-2025
BRIDGEWATER, N.J., June 05, 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 the first subject has been dosed in a Phase 2b trial evaluating VYN201 in subjects with either active or stable nonsegmental vitiligo. VYN201 is a novel pan-bromodomain and extra-terminal domain (BET) inhibitor designed for local administration. Top-line data from the 24-week vehicle-controlled treatment period are expected in mid-2025.
The randomized, double-blind, vehicle-controlled trial will evaluate the safety and efficacy of once-daily VYN201 topical gel in three dose cohorts (
“Dosing the first subject in the Phase 2b trial for vitiligo is an important milestone for the VYN201 program and our Company,” said David Domzalski, President and CEO of VYNE. “In our prior Phase 1b trial, VYN201 demonstrated a significant clinical response with a rapid onset of action and a favorable safety and tolerability profile, including low systemic exposure. We believe that VYN201 has the potential to become a valuable and differentiated therapy for patients with vitiligo. We look forward to reporting top-line data from the 24-week treatment period in mid-2025.”
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
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 BET Inhibitors
BET proteins play a key role in regulating gene transcription via epigenetic interactions (“reading”), and recent research has identified 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.
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 (“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 the potential benefits of VYN201 as a therapy for nonsegmental vitiligo and the expected timing for receipt of top-line results from the Phase 2b trial in mid-2025. 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 enroll subjects in its clinical trials and 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.
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
Media Relations:
Mike Beyer
Sam Brown Inc.
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