Aclaris Therapeutics (ACRS) Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary

Pipeline overview and development updates

• Focus on large and small molecule therapeutics, including TSLP mAb in a 90-patient study for moderate to severe atopic dermatitis (AD) with readout expected in late 2026.

• Bispecific antibody combining TSLP mAb and IL-4R construct showed highly positive PK/PD data in initial cohorts, with further results expected soon.

• Two I-B studies underway: one in severe AD and another in moderate asthma, both with readouts anticipated in late 2026.

• Oral small molecule program led by ITK/JAK3 inhibitor 2138, phase II-B ready, with lead indication selection imminent.

• Next-generation ITK-selective compounds advancing toward IND, with clinical entry expected in the coming months.

Clinical data and differentiation

• Bosakitug, a TSLP antibody, demonstrated 94% EASI 75 and 88% IGA 0/1 in a prior open-label study, significantly outperforming comparators.

• Current phase II study is placebo-controlled, 90 subjects, 2:1 randomization, aiming to confirm efficacy over 24 weeks.

• Dosing interval for Bosakitug may extend to 2–3 months, based on sustained response post-treatment.

• Bispecific antibody achieved a 26-day half-life and robust target engagement for both TSLP and IL-4R, supporting infrequent dosing.

• Healthy volunteer data showed strong inhibition of both targets, with plans to test in severe AD and moderate asthma populations.

Scientific rationale and safety

• Dual targeting of TSLP and IL-4R aims for deeper and broader efficacy in AD and asthma, addressing both T2 high and low endotypes.

• Bispecific approach expected to impact both innate and adaptive immunity, with broad downstream effects.

• Injection site reactions were the most common adverse event, mild and self-resolving, not dose-related.

• ITK inhibitors designed for selectivity and safety, with covalent binding to cysteine in the kinase pocket, differentiating from prior industry attempts.

• Safety data for lead ITK/JAK3 inhibitor (2138) in chronic tox and clinical studies has been favorable.