VYNE Therapeutics reports results from preclinical models for VYN202

VYNE Therapeutics announced new preclinical data showing the positive effect of its oral small molecule BD2-selective BET inhibitor, VYN202, in preclinical models of psoriasis and rheumatoid arthritis. Key findings from preclinical in vivo models: Psoriasis: In a well-established model, a psoriasis phenotype was induced in BALB-C mice. Treatment was then administered intraperitoneally with either VYN202, deucravacitinib or placebo. VYN202 and deucravacitinib at equivalent dosing demonstrated comparable onset of action and efficacy. Mice receiving VYN202 3mg/kg had approximately 95% mean reduction in PASI score from baseline by day 7 of treatment, which was consistent with the results in the deucravacitinib 3mg/kg group. Treatment with VYN202 3mg/kg reduced the expression of IL-17A, by greater than93% compared to placebo. Treatment with VYN202 at all doses also resulted in a marked reduction of other disease-related cytokines compared to the placebo group. Rheumatoid Arthritis: In a 21-day collagen-induced arthritis model, signs and symptoms of inflammatory arthritis were induced in Lewis rats. Each treatment group orally received either placebo, GSK620 at 10 mg/kg, or VYN202 at three different dose strengths. Treatment with VYN202 10mg/kg QD resulted in a 71% reduction in the overall signs and symptoms of rheumatoid arthritis at day 21, compared to mice receiving placebo. Treatment with VYN202 10mg/kg QD resulted in a 79% lower paw volume compared to mice receiving placebo. 75% of the animals treated with the highest dose of VYN202 presented with normal joint histopathology at the end of the study, whereas animals treated with placebo experienced marked inflammatory cell infiltrate, granulation tissue, bone erosion and cartilagenous ulceration. Treatment with VYN202 10mg/kg achieved a 98% lower expression of Immunoglobin G1, a biomarker associated with rheumatoid arthritis, compared to treatment with placebo. Treatment with VYN202 at 3 and 10mg/kg demonstrated a statistically-significant superior anti-inflammatory effect compared to GSK620 10mg/kg for all study efficacy endpoints. Next Steps R&D Day Event: VYNE will host an R&D Day event on Thursday, November 9, 2023 at 1:30 p.m. ET. VYNE management will discuss these data as well as the final data from VYNE’s Phase 1b trial evaluating VYN201 in vitiligo. The Company will also discuss its development plans for VYN201 and VYN202. Register Here IND Submission: VYNE expects to submit its IND for VYN202 by year-end 2023 and commence a first-in-human Phase 1a single ascending dose/multiple ascending dose trial in the first quarter of 2024. If successful, VYNE anticipates commencing Phase 1b trials in moderate-to-severe plaque psoriasis and in moderate-to-severe adult-onset rheumatoid arthritis in the second half of 2024.