Aclaris Therapeutics (NASDAQ:ACRS) outlined its immunology pipeline and upcoming clinical milestones during a presentation at the Bank of America Healthcare Conference, with President and Chief Operating Officer Hugh Davis emphasizing programs in dermatologic and respiratory diseases.
Davis described Aclaris as focused on immunological assets aimed at validated targets, with both biologic and small-molecule development capabilities. He said the company is pursuing approaches including bispecific antibodies and oral ITK inhibitors, supported by a research lab in St. Louis focused on kinase biology.
Pipeline Focus Includes TSLP, IL-4R and ITK Programs
Bosakitug is in a placebo-controlled Phase 2 study in moderate-to-severe atopic dermatitis with about 100 subjects, with top-line results expected by year-end, Davis said. He characterized TSLP as a “master regulator” of Th2 pathway indications and said Aclaris believes bosakitug has best-in-class potential based on its binding profile.
According to Davis, bosakitug has shown more than 400 hours of residence time on TSLP in testing, which he said is about 25 to 30 times longer than tezepelumab, the only approved anti-TSLP antibody to date. He also pointed to prior proof-of-concept data in atopic dermatitis, saying more than 90% of subjects achieved an EASI 75 response and 88% achieved an IGA 0/1 response.
Bispecific Candidate Shows Extended Pharmacokinetic Profile
ATI-052 combines the company’s anti-TSLP antibody with binding to IL-4R. Davis said the bispecific was about four times more potent than the combination of dupilumab and tezepelumab in inhibiting chemokine secretion from activated peripheral blood mononuclear cells in preclinical testing.
In the healthy volunteer portion of a Phase 1 study, Davis said ATI-052 showed extended pharmacokinetic duration out to 20 weeks after the last dose at week four, at the 480 mg and 240 mg dose levels. He said pharmacodynamic data showed 100% inhibition of TSLP-stimulated TARC through week 20 after the last dose, and 100% inhibition of IL-4-stimulated activity for at least 12 weeks in the 480 mg cohort.
“The PK/PD effect that we’re seeing here actually gives us the potential to dose this drug up to every three months,” Davis said. He added that the adverse event profile was favorable, with no serious adverse events, no treatment-related adverse events and no conjunctivitis reported in that portion of the study.
Aclaris has two ongoing Phase 1b studies of ATI-052, one in severe atopic dermatitis and one in asthma. Davis said both are expected to read out in the second half of the year, with initiation of a Phase 2b asthma program planned by year-end.
ATI-2138 to Move Into Lichen Planus Study
Davis also discussed ATI-2138, an oral ITK/JAK3 inhibitor that completed a Phase 2a proof-of-concept study in atopic dermatitis. He said the drug demonstrated “significant itch relief” and improvements in disease severity and disease extent in that study.
In the atopic dermatitis proof-of-concept trial, Davis said 63% of subjects had a greater than four-point improvement in PP-NRS itch score, and the study showed a 77% drop in EASI score. He also said pharmacodynamic analysis showed sustained target occupancy and functional ITK inhibition across the dosing interval at a 10 mg twice-daily dose.
Aclaris plans to initiate a Phase 2b study of ATI-2138 in lichen planus by year-end. Davis said the basket study will include mucosal and cutaneous lichen planus, as well as lichen planopilaris, a scarring alopecia of the scalp. He described lichen planus as a condition with no approved therapy and said the company is pursuing an accelerated regulatory pathway as an orphan indication.
Cash Runway Expected Through 2028
Davis said Aclaris expects to submit an investigational new drug application for ATI-9494 by year-end. He also said the company has a third-generation ITK-selective inhibitor expected to emerge in 2027.
The company expects its current resources to fund its planned catalysts and development activities, Davis said. He reported that Aclaris had about $190 million on its balance sheet as of the end of March and a cash runway extending through 2028.
About Aclaris Therapeutics (NASDAQ:ACRS)
Aclaris Therapeutics, Inc (NASDAQ:ACRS) is a clinical‐stage biopharmaceutical company focused on discovering, developing and commercializing novel small‐molecule therapies for dermatologic diseases and related rare disorders. The company’s pipeline includes several product candidates designed to address chronic inflammatory skin conditions and non‐melanoma skin lesions. Lead programs include ATI‐50002, a topical agent in late‐stage development for molluscum contagiosum removal; ATI‐50003 for common wart resolution; ATI‐1501, an oral JAK1/2 inhibitor targeting pruritic disorders; and ATI‐450, an oral MK2 inhibitor for inflammatory indications.
Founded in 2016 and headquartered in Malvern, Pennsylvania, Aclaris leverages proprietary chemistry platforms and translational research capabilities to advance multiple clinical and preclinical candidates.
