VYNE Therapeutics Announces Dosing of First Participants in Phase 1a Trial of Novel BD2-Selective BET Inhibitor VYN202
VYNE Therapeutics has initiated dosing in the Phase 1a trial of its novel BD2-selective BET inhibitor, VYN202. This first-in-human, double-blind, placebo-controlled study will enroll around 64 healthy volunteers to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VYN202.
The trial includes single ascending dose (SAD) and multiple ascending dose (MAD) components, with top-line data expected in the second half of 2024. VYN202 aims to treat immuno-inflammatory diseases by selectively targeting the BD2 bromodomain of BET proteins, potentially offering a better benefit-risk profile.
Preclinical testing has shown promising results in reducing disease severity and biomarkers. VYNE is optimistic about VYN202's potential to address a range of immune-mediated diseases.
- Initiation of Phase 1a trial for VYN202, indicating progression in clinical development.
- VYN202 has shown promising preclinical results in reducing disease severity and biomarkers.
- The trial aims to evaluate multiple critical parameters: safety, tolerability, pharmacokinetics, and pharmacodynamics.
- Top-line data expected in the second half of 2024, providing a clear timeline for investors.
- VYN202’s BD2-selectivity may offer a better benefit-risk profile compared to earlier generation BET inhibitors.
- The trial is in early Phase 1a, indicating a long road ahead before potential market approval.
- Data and safety results from preclinical studies may not directly translate to clinical success.
- Enrollment and completion of the trial may face delays, affecting timelines.
- No financial data or immediate revenue implications are reported, which may concern short-term investors.
Insights
The initiation of a Phase 1a trial for VYN202 is an important milestone for VYNE Therapeutics. Clinical trials are important in determining the safety, tolerability and preliminary efficacy of new drug candidates. VYN202's design focusing on BD2-selectivity is particularly noteworthy as it aims to minimize gastrointestinal and hematologic toxicities observed in prior generation BET inhibitors. This selective approach can potentially lead to more effective and safer treatments for immuno-inflammatory diseases.
From a scientific standpoint, top-line data expected in 2H'24 will be pivotal. Positive outcomes could validate the preclinical successes and pave the way for more advanced trials. However, investors should be aware that Phase 1 trials primarily assess safety and dosage range, not efficacy, which means the road to market approval is still long and uncertain.
In simple terms, this trial is like the first major test drive of a new car. It won't tell us everything, but it’s essential for understanding how the car performs on the road and lays the groundwork for further testing.
For retail investors, the announcement indicates a step forward in VYNE Therapeutics' pipeline, potentially enhancing the company's valuation and investor confidence. Clinical trials are expensive and success at this stage could attract additional funding or partnerships. Importantly, VYNE has highlighted the potential for VYN202 to address a broad range of immune-mediated diseases, which could open up multiple revenue streams if the drug reaches the market.
However, investors should also consider the risk factors. Early-stage clinical trials frequently encounter setbacks and there is no guarantee of success. It's prudent to monitor upcoming clinical data releases in 2H'24 closely, as these will significantly influence the stock's trajectory.
Think of this as a high-stakes gamble: the potential payoff can be huge, but the risks are equally significant. Ensuring a diversified portfolio and not putting all your eggs in one basket can mitigate some of this risk.
VYN202 has been designed to achieve class-leading potency and BD2-selectivity
Trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202 in healthy volunteers; top-line data expected in 2H’24
BRIDGEWATER, N.J., June 13, 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 healthy volunteers have been dosed in the Phase 1a trial of VYN202. VYN202 is an oral small molecule BD2-selective bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immuno-inflammatory diseases. Top-line data are expected in the second half of 2024.
“We are pleased to announce the initiation of the first-in-human clinical trial of VYN202, a highly selective and potent orally administered BET inhibitor. In preclinical testing, VYN202 achieved consistent improvements in disease severity across a variety of inflammatory and fibrotic models as well as reductions in pro-inflammatory and disease-related biomarkers,” said David Domzalski, President and CEO of VYNE. “We believe VYN202 has significant potential as a treatment option for a broad range of immune-mediated diseases, and we look forward to reporting top-line data from the Phase 1a trial in the second half of this year.”
The Phase 1a trial is a first-in-human double-blind, placebo-controlled study in healthy volunteers and consists of single ascending dose (SAD) and multiple ascending dose (MAD) components. The trial is currently expected to enroll approximately 64 healthy adult subjects into five SAD and three MAD cohorts to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202.
“Early generation BET inhibitors show similar affinity to both BD1 and BD2 bromodomains of BET proteins that has been implicated in both gastrointestinal and hematologic dose limiting toxicities,” said Dr. Iain Stuart, Chief Scientific Officer of VYNE. “We believe VYN202’s high potency and selectivity towards the BD2 bromodomain of BET proteins may result in an improved benefit-risk profile when treating immuno-inflammatory diseases. Following highly encouraging preclinical data, we are eager to evaluate the clinical safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202 to further inform our future clinical development plans.”
About VYN202
VYN202 is an innovative, oral small molecule BD2-selective BET inhibitor that has been designed to achieve class-leading selectivity (BD2 vs. BD1), maximum potency versus BD2, and optimal oral bioavailability. By maximizing BD2 selectivity, VYNE believes VYN202 has the potential to be a 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 is common. VYN202 is structurally distinct from VYNE’s pan-BET inhibitor (VYN201) and covered by distinct PCT and provisional composition of matter patent applications directed to new chemical entities and their uses.
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 VYN202 as a therapy for a broad range of immune-mediated diseases and the expected timing for reporting top-line results from the Phase 1a trial in the second half 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 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.
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.
312-961-2502
mikebeyer@sambrown.com
FAQ
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What makes VYN202 different from earlier generation BET inhibitors?
