US-based biopharmaceutical company VYNE Therapeutics has received US Food and Drug Administration clearance for its investigational new drug (IND) application for VYN202, allowing it to begin a Phase Ia clinical trial.
The double-blind, placebo-controlled, first-in-human trial will assess VYN202's safety, pharmacokinetics, pharmacodynamics and efficacy in both single ascending-dose (SAD) and multiple ascending-dose (MAD) portions.
VYN202 is a selective bromodomain and extra-terminal domain (BET) inhibitor designed for treating immuno-inflammatory conditions.
Around 64 healthy adult participants will be enrolled across five SAD and three MAD cohorts in the study.
If the Phase Ia segment is successful, VYNE will advance the drug to Phase Ib trials in individuals suffering from moderate-to-severe plaque psoriasis and moderate-to-severe adult-onset rheumatoid arthritis.
The company expects to report top-line results from the SAD/MAD trial in the second half of this year, with further results expected in the second half of next year.
VYN202 is an oral small molecule designed for high selectivity (BD2 vs BD1), potent BD2 inhibition and optimal oral bioavailability.
VYNE believes that by focusing on BD2 selectivity, the drug could offer a convenient, non-biologic treatment for acute and chronic management of immuno-inflammatory diseases, where uncontrolled inflammatory signalling is prevalent.
VYNE Therapeutics president and CEO David Domzalski said: “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.
“We look forward to initiating the Phase Ia trial in the coming weeks to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202.”
Last year, Tay Therapeutics and VYNE Therapeutics signed a licensing deal for the development of VYN202 as a possible treatment for immune-inflammatory and fibrotic disorders.
The drug has previously shown the potential to cause anti-inflammatory and anti-fibrotic effects in preclinical models.
