RAPT Therapeutics Discontinues Zelnecirnon Program Following FDA Safety Concerns
核心洞察
RAPT Therapeutics halts its zelnecirnon (RPT193) program after the FDA placed clinical holds on Phase 2 trials for asthma (搜索) and atopic dermatitis (搜索) due to liver injury (搜索).
The clinical hold was initiated after a patient in the atopic dermatitis (搜索) trial experienced a serious adverse event involving liver injury (搜索) requiring a transplant.
RAPT plans to advance next-generation CCR4 (搜索) compounds with improved safety profiles and expects to identify a new candidate in the first half of 2025.
RAPT Therapeutics, Inc. (Nasdaq: RAPT) has announced the termination of its zelnecirnon (RPT193) program after the U.S. Food and Drug Administration (FDA) placed clinical holds on two Phase 2 trials evaluating the drug in asthma (搜索) and atopic dermatitis (搜索). The decision follows safety concerns raised by the FDA after a serious adverse event (SAE) of liver injury (搜索) requiring a transplant occurred in one patient participating in the atopic dermatitis trial. No other instances of liver toxicity or treatment-related SAEs were reported among other trial participants. The company closed both studies before completing planned enrollment.
Safety Concerns Prompt Program Halt
The clinical holds were implemented in February 2024 after the single case of severe liver injury (搜索) was reported. This adverse event led the FDA to request additional safety data and prompted a thorough review of the zelnecirnon program. "In light of the agency’s feedback, we do not see a viable path forward for zelnecirnon," stated Brian Wong, M.D., Ph.D., President and CEO of RAPT. Despite this setback, Dr. Wong affirmed the company's belief in CCR4 (搜索) as a promising target for inflammatory diseases.
Pivot to Next-Generation CCR4 Compounds
RAPT Therapeutics is now shifting its focus to developing next-generation CCR4 (搜索) compounds with the goal of improved safety margins. The company anticipates identifying a new drug candidate in the first half of 2025. This strategic pivot aims to leverage the potential of CCR4 inhibition while mitigating the safety risks observed with zelnecirnon. The company is also actively seeking in-licensing opportunities for clinical-stage assets to expand its pipeline.
Company Statement and Future Plans
"We plan to continue advancing our next generation CCR4 (搜索) compounds with improved safety margins for inflammatory disease and expect to identify a new candidate in the first half of 2025," Dr. Wong commented. The company's focus remains on developing oral small molecule therapies for inflammatory diseases and oncology, addressing significant unmet needs in these areas. RAPT Therapeutics will continue to advance its preclinical pipeline and explore external opportunities to strengthen its portfolio.