Aclaris begins phase 2 trial for atopic dermatitis drug

WAYNE, Pa. - Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company with a market capitalization of $158 million, announced today the commencement of a Phase 2 trial for bosakitug, an investigational monoclonal antibody for patients with moderate-to-severe atopic dermatitis (AD). According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics, with analyst price targets ranging from $2 to $16 per share. The trial follows promising results from an earlier Phase 2a study and aims to further assess the drug’s efficacy and safety.

The current randomized, double-blind, placebo-controlled trial will involve approximately 90 patients. Its primary measure is the percent change in the Eczema Area and Severity Index (EASI) at week 24, with secondary endpoints including various EASI responses and the Peak Pruritus Numerical Rating Scale (PP-NRS) score. The company maintains a strong financial position, with InvestingPro data showing more cash than debt on its balance sheet and a healthy current ratio of 5.06, indicating robust short-term liquidity.

Bosakitug, also known as ATI-045, is designed to bind to and neutralize thymic stromal lymphopoietin (TSLP), a cytokine implicated in several inflammatory and allergic conditions. By blocking TSLP’s interaction with its receptor complex, bosakitug aims to prevent the release of proinflammatory cytokines by immune cells.

Dr. Jesse Hall, Chief Medical Officer of Aclaris, expressed optimism about bosakitug’s potential, citing its "superior potency and residence time, and unique TSLP binding characteristics." The company anticipates providing top line results from the Phase 2 trial in the second half of 2026.

Atopic dermatitis, the most common form of eczema, affects millions worldwide and can significantly impact the quality of life. Aclaris holds exclusive worldwide rights to bosakitug, excluding Greater China, and is exploring its potential to treat a variety of atopic, immunologic, and respiratory diseases.

The company’s forward-looking statements include expectations regarding the development timeline and therapeutic potential of bosakitug. While these statements involve inherent risks and uncertainties that could cause actual results to differ materially from those projected, recent market data shows encouraging signs, with the stock posting a significant 15.87% return over the last week. For deeper insights into ACRS’s financial health and growth prospects, investors can access comprehensive analysis and additional ProTips through InvestingPro’s detailed research reports, available for over 1,400 US stocks.

Investors are advised that this announcement is based on a press release statement from Aclaris Therapeutics, and the company’s development plans for bosakitug are subject to change based on various factors, including clinical trial outcomes and regulatory requirements.

In other recent news, Aclaris Therapeutics has been in the spotlight with several significant developments. The company has received FDA clearance for its Investigational New Drug application for ATI-052, a bispecific monoclonal antibody targeting inflammation mediators, with clinical trials expected to begin in the second quarter of 2025. Additionally, Wedbush initiated coverage on Aclaris with an Outperform rating and a price target of $8, highlighting the potential of its lead biologic, bosakitug, in treating atopic dermatitis. H.C. Wainwright adjusted its price target for Aclaris to $16, maintaining a Buy rating, as the company prepares for a Phase 2 trial of bosakitug.

Furthermore, Scotiabank has set a price target of $15 for Aclaris, also assigning a Sector Outperform rating, noting the potential upside due to upcoming data releases. In corporate news, Aclaris appointed Jesse Hall, M.D., as its new Chief Medical Officer, who will lead the company’s clinical strategy. Aclaris continues to advance its drug development pipeline, with its regional partner in China conducting Phase 3 trials for related indications. These recent developments underscore Aclaris’s strategic focus on immuno-inflammatory diseases, with multiple product candidates in various stages of clinical trials.

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