Pharma Focus Asia

VYNE Therapeutics Receives FDA Clearance for IND Application of VYN202, a Unique BD2-Selective BET Inhibitor

Tuesday, May 07, 2024

VYNE Therapeutics Inc. (Nasdaq: VYNE) announced today that the U.S. Food and Drug Administration has cleared its Investigational New Drug application (IND) for VYN202, an oral BD2-selective BET inhibitor. This marks a significant advancement in the company's efforts to develop therapies for autoimmune diseases. David Domzalski, President and CEO of VYNE, expressed excitement about the potential of VYN202 as a treatment option.

The company plans to initiate a Phase 1a trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VYN202 in healthy volunteers. This trial will include single ascending dose/multiple ascending dose (SAD/MAD) components and is expected to enroll approximately 64 subjects. Pending successful completion of Phase 1a, VYNE intends to move forward with Phase 1b trials targeting moderate-to-severe plaque psoriasis and adult-onset rheumatoid arthritis, with results anticipated in the latter half of 2025.

VYN202 is an oral small molecule BD2-selective BET inhibitor designed to offer high selectivity, potency, and oral bioavailability. It differs structurally from VYNE's pan-BET inhibitor, VYN201, and is covered by distinct patent applications.

BET proteins play a crucial role in gene transcription regulation through epigenetic interactions, particularly in modulating B and T cell activation and inflammation. BET inhibitors hold promise for addressing various immuno-inflammatory and fibrotic diseases by blocking pro-inflammatory cytokine transcription, with potential applications in myeloproliferative neoplastic disorders.



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