Aclaris Therapeutics (ACRS) HCW Annual Inflammation & Immunology Virtual Conference 2025 summary

Portfolio Overview and Strategy

• Focus on developing large and small molecule therapeutics for inflammation and immunology, leveraging a proprietary drug discovery engine and experienced leadership team.

• Three clinical-stage assets: ATI-2138 (oral ITK/JAK3 inhibitor), ATI-045/bosakitug (TSLP monoclonal antibody), and ATI-052 (bispecific TSLP/IL-4R antibody), each targeting multi-billion dollar markets.

• Preclinical pipeline includes next-gen ITK inhibitors and novel bispecific constructs, with an IND for the next-gen ITK selective planned for 2026.

• Proprietary discovery platform and multidisciplinary team drive innovation and candidate selection.

• Actively seeking ex-China partners for ATI-045/bosakitug and other assets in respiratory and non-dermatology indications.

Clinical Development Progress and Upcoming Milestones

• Bosakitug Phase 2 trial in atopic dermatitis began in Q2 2025, with top-line data expected in 2H 2026.

• ATI-052 Phase 1a/1b program started in Q2 2025; top-line results anticipated in early and 2H 2026.

• ATI-2138 Phase 2a open-label trial completed; top-line results expected July 2025, with plans to initiate a study in alopecia areata.

• IND for next-gen ITK selective molecule to be filed in 2026, with phase I work to follow.

• Multiple clinical catalysts expected in 2025 and 2026, including data readouts and new IND submissions.

Scientific and Competitive Highlights

• Bosakitug demonstrates over 60x greater inhibition of CCL17 production compared to tezepelumab, with a residence time of over 400 hours on TSLP and supports extended dosing intervals.

• Phase II A study of bosakitug in atopic dermatitis showed rapid, deep, and durable clinical responses, with high responder rates (94% EZ75, 88% IGA).

• ATI-052 bispecific antibody shows up to 5x greater potency than tezepelumab and dupilumab combined in functional assays.

• ATI-2138 is 44.4x more potent than ritlecitinib for ITK inhibition and 5.4x for JAK3 inhibition, with strong inhibition of TH2 cytokines.

• Next-gen ITK selective aims to address both TH2 and TH17 inflammation, targeting allergic and atopic diseases while minimizing JAK safety concerns.