Hold on VYN202 phase 1b for psoriasis

[Fred]

VYNE has suspended all screening, enrolment and patient dosing in the Phase 1b trial of VYN202 for psoriasis.

VYN202: Oral BD2-selective BET inhibitor

VYN202 has been designed to achieve class-leading selectivity (BD2 vs. BD1), maximum potency versus BD2 and optimal oral bioavailability. Maximizing on-target potency vs. BD2 and minimizing affinity to BD1 may be the key to optimizing the benefit/risk profile of BET inhibitors for autoimmune diseases.

Target Markets:
Moderate-to-severe plaque psoriasis
Moderate-to-severe rheumatoid arthritis

Focused activity:
VYN202 is believed to be the most potent and BD2-selective BET Inhibitor in clinical development which is designed to improve efficacy and tolerability.

Quote:

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VYNE Therapeutics today announced that the U.S. Food and Drug Administration (FDA) verbally informed the Company that it placed a clinical hold on the Company’s Phase 1b study evaluating VYN202 for the treatment of moderate-to-severe plaque psoriasis. The clinical hold determination was made following a recent observation of testicular toxicity in dogs from a non-clinical toxicology study with VYN202.

VYNE has suspended all screening, enrollment and patient dosing in the Phase 1b trial of VYN202 and intends to work diligently with the FDA to resolve the clinical hold as soon as possible. To date, there have been no serious adverse events observed in subjects that have been enrolled in the Phase 1b study.

“While we are disappointed by this unexpected development, the safety and well-being of patients in our studies is our top priority,” said David Domzalski, President and Chief Executive Officer of VYNE. “We intend to work closely with the FDA to address the clinical hold as expeditiously as possible and we plan to provide additional updates pending continued engagement with FDA.”

Source: vynetherapeutics.com