FDA clears Aclaris’ new drug for clinical trial

WAYNE, Pa - Aclaris Therapeutics, Inc. (NASDAQ: ACRS), currently trading at $1.13 and showing signs of being undervalued according to InvestingPro analysis, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application, marking a significant step in advancing ATI-052, a bispecific anti-TSLP/IL-4R monoclonal antibody, into clinical trials. The company, which specializes in developing treatments for immuno-inflammatory diseases and maintains a healthy current ratio of 3.99, announced today that the Phase 1a/1b trial is expected to commence in the second quarter of 2025. InvestingPro data shows the company holds more cash than debt on its balance sheet, though it’s currently experiencing rapid cash burn.

ATI-052 is designed to simultaneously target two key mediators of inflammation, thymic stromal lymphopoietin (TSLP) and the interleukin-4 receptor (IL-4R), potentially inhibiting a central proinflammatory pathway and offering enhanced efficacy over traditional monoclonal antibodies. This dual blockade could be beneficial in treating a range of atopic, immunologic, and respiratory diseases.

The upcoming randomized, blinded, placebo-controlled clinical trial will assess the safety and tolerability of single and multiple ascending doses of ATI-052, followed by a proof-of-concept portion for an undisclosed indication. Bispecific antibodies like ATI-052 are engineered with two distinct binding domains, allowing for the simultaneous engagement of two different targets, which may improve treatment outcomes for patients with immune-modulated diseases.

Aclaris Therapeutics has exclusive worldwide rights to ATI-052, with the exception of Greater China, as part of its license agreement with Biosion, Inc. Dr. Hugh Davis, President and Chief Operating Officer of Aclaris, expressed the company’s commitment to therapeutic innovation, particularly in the development of bispecific antibodies for immuno-inflammatory disorders.

The IND application process is a critical step in drug development, requiring the submission of comprehensive information about the investigational drug, including its composition, preclinical data, and proposed clinical trial protocols.

As a clinical-stage biopharmaceutical company, Aclaris Therapeutics continues to build its portfolio of novel product candidates aimed at addressing the unmet needs of patients with immuno-inflammatory diseases. This FDA clearance represents an important milestone for the company and its development plans for ATI-052.

The information in this article is based on a press release statement from Aclaris Therapeutics, Inc.

In other recent news, Aclaris Therapeutics has been the subject of notable developments that have caught the attention of investors. Scotiabank has initiated coverage on Aclaris Therapeutics, assigning a Sector Outperform rating and setting a price target of $15.00. This move comes after a significant drop in the company’s stock, which has decreased by approximately 50% from its one-year high. The bank’s analysts view this as a potential opportunity for investors, particularly with upcoming data from Chia Tai-Tianqing Pharmaceutical Holdings Co.’s asthma program expected in early 2025, which could impact Aclaris’s ATI-045. Additionally, Aclaris has announced the formation of a new Scientific Advisory Board, which includes renowned pulmonologists Marianne Mann, M.D., and Zuzana Diamant, M.D., Ph.D. The expertise of these board members is anticipated to enhance the company’s drug development efforts, particularly in immuno-inflammatory diseases. Aclaris is also highlighted for its solid financial position, with a cash runway extending into 2028, allowing it to continue operations and research without immediate financial pressure. The company’s pipeline includes additional readouts planned through 2026, offering a steady flow of potential catalysts for its stock.

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