Aclaris Therapeutics reported that its anti‑TSLP/IL‑4Rα bispecific antibody ATI‑052 achieved positive interim results in a first‑in‑human Phase 1a study. The single‑ascending‑dose and multiple‑ascending‑dose cohorts showed a strong safety and tolerability profile, with no Grade 3 treatment‑emergent adverse events and no serious adverse events. Pharmacokinetics were dose‑proportional and the drug’s half‑life was at least 26 days, supporting extended dosing intervals. Pharmacodynamic data demonstrated robust target engagement and concentration‑dependent inhibition of inflammatory markers.
The results are significant because ATI‑052 is Aclaris’s first biologic asset and the company’s first bispecific antibody. By targeting both TSLP and IL‑4Rα, the drug can simultaneously modulate two key pathways implicated in atopic dermatitis and asthma, potentially offering a best‑in‑class therapeutic option in high‑growth markets that are currently dominated by JAK inhibitors and other biologics.
Aclaris plans to launch Phase 1b proof‑of‑concept trials in atopic dermatitis and asthma in the first quarter of 2026, with top‑line data expected in the second half of 2026. A Phase 2b trial in atopic dermatitis is slated for the second half of 2026. These accelerated timelines reflect the company’s confidence in the safety and pharmacology profile of ATI‑052 and its potential to shorten the development path to regulatory approval.
Financially, Aclaris had a cash balance of $190.5 million at the end of Q1 2025, providing a runway through the first half of 2028. The company is not expected to be profitable in the near term; however, it reported a Q3 2025 earnings per share of –$0.12, beating the estimate of –$0.14, and revenue of $3.30 million, exceeding the estimate of $1.59 million. The next earnings report is scheduled for February 26 2026. Aclaris also has other pipeline candidates, including the ITK inhibitor ATI‑2138, and continues to pursue preclinical work on next‑generation bispecific antibodies.
Aclaris was added to the Nasdaq Biotechnology Index effective at market close on Friday, January 2 2026, reflecting growing investor interest in its clinical‑stage pipeline. The company’s strong safety profile, dose‑proportional pharmacokinetics, and extended half‑life position ATI‑052 as a promising candidate that could accelerate the company’s entry into the atopic dermatitis and asthma markets.
Dr. Neal Walker, CEO of Aclaris, said the interim data “exceeded our expectations” and underscored the drug’s best‑in‑class potency and its ability to uniquely impact multiple inflammatory pathways. He emphasized that the results support a rapid progression into Phase 1b and Phase 2b studies, reinforcing the company’s strategy to diversify beyond small molecules and strengthen its competitive positioning in the immuno‑inflammatory space.
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