VYNE Therapeutics announces results from MAD portion of Phase 1a SAD/MAD trial

VYNE Therapeutics (VYNE) announced positive results from the multiple ascending dose, MAD, portion of its Phase 1a SAD/MAD trial of VYN202. The Phase 1a trial was a two-part, double-blind, placebo-controlled dose-escalation study in healthy volunteers consisting of single ascending dose and MAD components to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202. Key Findings from the Top-line Phase 1a MAD Results for VYN202: VYN202 demonstrated a favorable safety and tolerability profile with no drug-related adverse events historically associated with earlier generation, less selective bromodomain and extra-terminal domain inhibitors, including thrombocytopenia, neutropenia or gastrointestinal toxicity findings. No serious adverse events, discontinuations due to an AE or clinically meaningful treatment emergent adverse events. All TEAEs were considered mild or moderate in severity. No drug-related adverse events associated with laboratory results. Favorable PK profile demonstrated for VYN202: Data supports once-daily dosing regimen. VYN202 demonstrated dose dependent exposure that reached steady-state after 7 once-daily doses. VYN202 blood levels were within key inhibitory thresholds of IC50 to IC90 against BD2 BRD4 for at least 24 hours at all doses. VYN202 demonstrated robust pharmacodynamic activity on target engagement and inflammatory biomarkers in ex vivo assays.