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On Wednesday, H.C. Wainwright maintained a Neutral stance on shares of Aclaris Therapeutics (NASDAQ:ACRS), following the company's announcement regarding the commencement of a Phase 2a trial for ATI-2138. Aclaris Therapeutics reported on September 17 that it had begun dosing the first patient in the trial, which is evaluating the drug as a potential treatment for moderate-to-severe atopic dermatitis (AD).
The drug, ATI-2138, is an investigational oral covalent inhibitor targeting both interleukin-2-inducible T cell kinase (ITK) and Janus kinase (JAK) 3. By inhibiting these pathways, the treatment aims to disrupt T cell signaling, which is a critical component in immune responses. The goal of the Phase 2a trial is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the drug, as well as its efficacy over a 12-week period.
The study, which is open-label and being conducted in the United States, plans to enroll approximately 15 subjects with moderate-to-severe AD. The primary focus of the trial is to monitor safety-related parameters, while secondary endpoints will assess various efficacy measures including the Eczema Area and Severity Index (EASI) and the Validated Investigator Global Assessment (vIGA).
Aclaris Therapeutics has indicated that it expects to release top-line data from this trial in the first half of 2025. The analyst from H.C. Wainwright reiterated the Neutral rating, noting the absence of a price target and stating the need for further clarity on the company's pipeline. The analyst also mentioned the status of ATI-1777 (lepzacitinib), which is being considered for out-licensing, as a factor in maintaining the current rating.
In a notable financial move, Aclaris sold a portion of its future royalty earnings from the sale of OLUMIANT, a treatment for alopecia areata, to OMERS, a Canadian pension plan. The deal included an upfront payment of $26.5 million to Aclaris, with the potential for an additional $5.0 million, contingent on specific sales milestones in 2024. OMERS now holds a share of the royalties from Eli Lilly and Company (NYSE:LLY)'s worldwide net sales of OLUMIANT starting April 2024.
Other recent developments include Cantor Fitzgerald & Co. and DLA Piper LLP (US) advised Aclaris on its transaction with OMERS. As part of its ongoing strategic review, Aclaris is actively identifying additional investment opportunities to complement its drug development pipeline.
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