RAPT Therapeutics (RAPT): Based on Recent FDA Feedback RAPT Therapeutics Stops Zelnecirnon Program Following Clinical Hold Due to Single SAE of Severe Liver Injury
RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today announced it is terminating its zelnecirnon (RPT193) program. Zelnecirnon was being evaluated in two randomized, placebo-controlled Phase 2 clinical trials in asthma and atopic dermatitis (AD), and both trials were placed on clinical hold by the U.S. Food and Drug Administration (FDA) in February 2024 due to a serious adverse event (SAE) of liver injury requiring transplant in one patient in the AD trial. No liver toxicity nor other treatment-related SAEs were reported in any other trial participant. The company subsequently closed both studies before completing the planned enrollment. Following feedback recently received from the FDA, the company has stopped its zelnecirnon program.
“In light of the agency’s feedback, we do not see a viable path forward for zelnecirnon, although we continue to believe that CCR4 remains an exciting target with the potential to provide a safe, oral therapeutic option across a number of inflammatory diseases,” commented Brian Wong, M.D., Ph.D., President and CEO of RAPT. “We plan to continue advancing our next generation CCR4 compounds with improved safety margins for inflammatory disease and expect to identify a new candidate in the first half of 2025. Additionally, we continue to actively pursue in-licensing opportunities for clinical-stage assets.”
About RAPT Therapeutics, Inc.
RAPT Therapeutics is a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Utilizing its proprietary discovery and development engine, the company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases.

