FDA Clears Investigational New Drug Application for Novel BD2-Selective BET Inhibitor, VYN202
Phase Ia trial of VYN202, expected to begin this quarter, will enroll approximately 64 healthy participants.
The FDA has cleared an Investigational New Drug Application (IND) for VYNE Therapeutics' VYN202, an oral BD2-selective BET inhibitor. VYNE plans to initiate a first-in-human Phase Ia single ascending dose/multiple ascending dose (SAD/MAD) trial in healthy volunteers this quarter with top line results expected in the second half of 2024.1
“VYN202 is a highly selective and potent orally administered BET inhibitor that we believe has significant potential as a treatment option for autoimmune diseases. Clearance of the IND for VYN202 marks a major step forward in this effort,” David Domzalski, president and CEO of VYNE said in a press release. “We look forward to initiating the Phase Ia trial in the coming weeks to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202.”
In October 2023, VYNE reported positive results from preclinical studies of VYN202 in models of psoriasis and rheumatoid arthritis.2
“We believe VYN202 has the potential to be the most potent and selective BET inhibitor in development and has consistently demonstrated its ability to improve signs and symptoms of disease with marked inhibition of key inflammatory cytokines implicated in the pathology of several chronic autoimmune diseases in preclinical models,” Domzalski said in an earlier press release. “These compelling preclinical data in skin inflammation and joint disease models highlight VYN202’s potential for therapeutic utility in both psoriasis and rheumatoid arthritis. We look forward to advancing these programs into the clinic next year and updating investors on our progress.”
The Phase Ia clinical trial of VYN202 is a double-blind, placebo-controlled study in healthy volunteers and consists of SAD and MAD components. It is expected to enroll approximately 64 healthy adult participants, who will be split into five SAD and three MAD cohorts to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202.
Looking forward, if this portion of the trial is successfully completed, VYNE plans to initiate Phase Ib trials in subjects with moderate-to-severe plaque psoriasis and moderate-to-severe adult-onset rheumatoid arthritis, with top line results anticipated in the second half of 2025.
References
1. VYNE Therapeutics Announces FDA Clearance of IND Application for VYN202, a Novel BD2-Selective BET Inhibitor. Press release. May 6, 2024. Accessed May 7, 2024. https://vynetherapeutics.com/press-releases/vyne-therapeutics-announces-fda-clearance-of-ind-application-for-vyn202-a-novel-bd2-selective-bet-inhibitor/
2. VYNE Therapeutics Reports Positive Results from Preclinical Models for Oral BD2-Selective BET Inhibitor VYN202. Press release. October 30, 2023. Accessed May 7, 2024. https://vynetherapeutics.com/press-releases/vyne-therapeutics-reports-positive-results-from-preclinical-models-for-oral-bd2-selective-bet-inhibitor-vyn202/
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.
