Vyne Therapeutics has dosed the first participant in a randomised Phase Ib clinical trial of VYN202, an oral treatment for moderate-to-severe plaque psoriasis.
The double-blind, placebo-controlled trial involves three dosing cohorts that will assess the therapy’s tolerability, pharmacokinetics and safety, with participants receiving either 0.25mg, 0.5mg, or 1mg doses, or a placebo once a day for 12 weeks.
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Approximately 20 participants will be allocated to each arm of the trial.
Secondary objectives of the trial include the assessment of the therapy’s pharmacokinetic profile, as well as preliminary efficacy evidence.
This will be measured by ‘improvements’ from baseline using psoriasis area and severity index (PASI) scores. The trial will also use other exploratory efficacy measures, such as Static Physician Global Assessment (sPGA), quality of life, biomarker analyses, and scalp disease.
The company anticipates top-line data from the 12-week trial by the end of this year. After the treatment period, all participants will undergo a four-week safety follow-up.
Vyne Therapeutics CEO and president David Domzalski said: “The initiation of the Phase Ib 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.
“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.”
Vyne noted that VYN202, with its bromodomain 2 (BD2)-selective bromodomain and extra-terminal domain (BET) inhibition, could provide a non-biologic alternative for chronic and acute management of immune-mediated conditions.
Last month, the company completed enrolment for its Phase IIb trial of VYN201 gel, also known as repibresib. This trial is focused on the treatment of non-segmental vitiligo.
