VYNE Therapeutics (VYNE) H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference summary

Platform overview and innovation

• Focused on developing BET inhibitors for autoimmune and inflammatory diseases, diverging from traditional oncology uses.

• Two main assets: Repibresib (topical, pan-BD BET inhibitor) and VYN202 (oral, highly selective BD2 BET inhibitor).

• InhiBET platform aims to address dose-limiting toxicities seen in earlier BET inhibitors.

• Repibresib uses tissue-targeted and soft drug approaches to minimize systemic exposure and adverse events.

• VYN202 is designed for high BD2 selectivity, reducing off-target effects and improving safety.

Clinical development and trial progress

• Repibresib is in a Phase IIb trial for non-segmental vitiligo, with enrollment completed and top-line data expected mid-year.

• The Phase IIb study includes four arms: vehicle and three active doses (1%, 2%, 3%), with a two-part design for extended evaluation.

• Proof-of-concept and preclinical data for Repibresib showed strong efficacy, especially at higher doses.

• VYN202 completed a Phase Ia SAD-MAD study, showing a clean safety profile and promising biomarker engagement.

• VYN202 is in a Phase Ib proof-of-concept study for moderate to severe plaque psoriasis, with results expected by year-end.

Safety, differentiation, and market positioning

• Repibresib’s topical delivery and soft drug design minimize GI and platelet-related toxicities.

• VYN202’s BD2 selectivity avoids BD1-related safety issues, with no significant GI or thrombocytopenia observed.

• Repibresib targets a significant unmet need in vitiligo, with potential as a first-line or adjuvant therapy.

• Once-daily dosing and lack of black box warning differentiate Repibresib from systemic JAK inhibitors.

• Both assets have potential for broader application in other inflammatory and autoimmune conditions.