Phase 1b Trial of VYN202 for psoriasis

[Fred]

Oral, once-daily doses of VYN202 being evaluated in subjects with moderate-to-severe plaque psoriasis.

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VYNE Therapeutics Inc a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, today announced that the first subject has been dosed in a Phase 1b trial evaluating VYN202 in moderate-to-severe plaque psoriasis. VYN202 is an oral small molecule BD2-selective bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immune-mediated diseases. The Phase 1b trial will primarily evaluate the safety of VYN202, administered orally once a day for 12 weeks, with secondary objectives to evaluate the pharmacokinetic profile and preliminary evidence of efficacy, including improvement from baseline in psoriasis area and severity index (PASI) scores. Top-line data from the 12-week randomized, placebo-controlled trial are expected by year-end 2025.

“The initiation of the Phase 1b trial in subjects with moderate-to-severe plaque psoriasis represents a major step forward in advancing our novel and highly selective oral BET inhibitor, VYN202,” said David Domzalski, President and Chief Executive Officer of VYNE. “Psoriasis shares common underlying biological pathways with several other chronic inflammatory conditions, and we believe results from this trial will provide key insights into VYN202’s potential use as a novel, once-daily oral treatment for chronic immune-mediated diseases.”

“Our Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) trial showed that VYN202 had a favorable safety profile and also demonstrated VYN202’s potential to inhibit the production of multiple inflammatory biomarkers related to Th17, TNF and Th1/myeloid dysregulated activity,” said Iain Stuart, PhD, Chief Scientific Officer of VYNE. “We look forward to reporting results from this robust Phase 1b trial by the end of this year.”

Source: vynetherapeutics.com