RAPT Therapeutics Discontinues Zelnecirnon Program Following FDA Feedback
核心洞察
RAPT Therapeutics halts the development of zelnecirnon (RPT193) after receiving feedback from the FDA regarding safety concerns.
The decision follows a clinical hold placed on Phase 2 trials for asthma (搜索) and atopic dermatitis (搜索) due to a severe liver injury in one patient.
RAPT plans to advance next-generation CCR4 (搜索) compounds with improved safety profiles and explore licensing opportunities for clinical-stage assets.
RAPT Therapeutics, Inc. (Nasdaq: RAPT) has announced the termination of its zelnecirnon (RPT193) program after recent feedback from the U.S. Food and Drug Administration (FDA). Zelnecirnon, an oral small molecule therapy, was under evaluation in Phase 2 clinical trials for asthma (搜索) and atopic dermatitis (搜索) (AD). The decision comes after the FDA placed a clinical hold on both trials in February 2024 due to a serious adverse event (SAE) involving liver injury requiring transplant in one patient participating in the atopic dermatitis trial.
The Phase 2 trials, designed as randomized, placebo-controlled studies, were halted before the planned enrollment was completed. While no other participants reported liver toxicity or treatment-related SAEs, the FDA's feedback prompted RAPT to discontinue the program.
Future Plans for RAPT Therapeutics
Brian Wong, M.D., Ph.D., President and CEO of RAPT, stated, "In light of the agency’s feedback, we do not see a viable path forward for zelnecirnon, although we continue to believe that CCR4 (搜索) remains an exciting target with the potential to provide a safe, oral therapeutic option across a number of inflammatory diseases." The company plans to focus on advancing its next-generation CCR4 compounds, engineered with improved safety margins, for treating inflammatory diseases. RAPT anticipates identifying a new candidate in the first half of 2025 and is also actively seeking in-licensing opportunities for clinical-stage assets.
RAPT Therapeutics is an immunology-based therapeutics company focused on creating oral small molecule therapies for inflammatory diseases and oncology. The company utilizes its discovery and development engine to modulate critical immune drivers underlying these diseases.