Vyne: Encouraging Pharmacokinetic, Hematology Data For Skin Disorder
- VYNE Therapeutics Inc announced first-in-human pharmacokinetic and hematology data from its Phase 1a single and multiple ascending dose trial for its investigational novel BET inhibitor, VYN201.
- In February 2023, the company announced positive preliminary safety and tolerability data from the trial.
- Results have shown that there were no quantifiable VYN201 plasma concentrations above the assay's lower limit of quantification (0.25ng/ml).
- In the Phase 1a trial, there was no evidence of low or lower platelet counts for any dose cohort at any time. The assay lower limit of quantification (LLOQ) of 0.25ng/ml is 720-fold below the free half maximal effective concentration (EC50) for VYN201 against the BD1 domain of the BET protein, BRD4.
- There was no effect on other assessed clinical, hematological parameters.
- Enrollment in the Phase 1b portion of the trial is ongoing and the company expects to report topline results in mid-2023.
- Based on the Phase 1a results in non-segmental Vitiligo patients, VYNE selected 0.5%, 1.0%, and 2.0% ointment strengths for evaluation in the ongoing Phase 1b study.
- In this portion of the study, up to 30 patients with a clinical diagnosis of non-segmental vitiligo will receive VYN201 once daily in three dose cohorts. The primary objective of the Phase 1b portion of the study will be to evaluate the safety and pharmacokinetics of VYN201.
- The exploratory efficacy of VYN201 in non-segmental vitiligo patients will also be evaluated.
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