Aclaris Therapeutics is providing a corporate outlook for 2023. Clinical Development Programs: Zunsemetinib, an investigational oral small molecule MK2 inhibitor: Rheumatoid Arthritis: This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of zunsemetinib in combination with methotrexate in subjects with moderate to severe rheumatoid arthritis is ongoing. Aclaris expects topline data in the second half of 2023. Hidradenitis Suppurativa: This Phase 2a trial to investigate the efficacy, safety, tolerability, PK and PD of zunsemetinib over 12 weeks in subjects with moderate to severe hidradenitis suppurativa has completed enrollment with 95 patients randomized and is ongoing. Aclaris expects topline data in mid-first half of 2023. Psoriatic Arthritis: This Phase 2a trial to investigate the efficacy, safety, tolerability, PK and PD of zunsemetinib in subjects with moderate to severe psoriatic arthritis (PsA) is ongoing. Aclaris expects topline data by year end 2023. ATI-1777, an investigational topical "soft" Janus kinase 1/3 inhibitor: Atopic Dermatitis: This Phase 2b trial to determine the efficacy, safety, tolerability, and PK of multiple doses and application regimens of ATI-1777 in subjects with moderate to severe AD is ongoing. Aclaris expects topline data mid-year 2023. ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor: Aclaris has selected ulcerative colitis as the intended first clinical development target for ATI-2138. Aclaris is also exploring additional indications that are relevant to the mechanism of action. Aclaris initiated a Phase 1 MAD trial of ATI-2138 in healthy volunteers in December of 2022. Aclaris expects topline data from the MAD trial in the second half of 2023. Preclinical development: ATI-2231, an investigational oral MK2 inhibitor compound: Second MK2 inhibitor generated from Aclaris’ proprietary KINect drug discovery platform and designed to have a long plasma half-life. Aclaris expects an IND to be submitted in 2023.
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