The US FDA Places Clinical Hold on the Trials Assessing RAPT Therapeutics’ Zelnecirnon
Shots:
- The US FDA has verbally informed a clinical hold on the P-IIa and P-IIb studies investigating zelnecirnon to treat asthma and atopic dermatitis, respectively, for which the company expects a formal letter
- The clinical hold was placed because of the liver failure reported in a patient in the atopic dermatitis study due to unknown reasons but is expected to be related with zelnecirnon. Recruitment for the new trials and drug’s dosing in both the P-II studies has been stopped but does not affect the study of tivumecirnon (FLX475) in oncology
- Additionally, the preclinical studies, two P-II studies and a previous P-Ia/Ib trial investigating zelnecirnon in patients (n=~350) did not show any signs of liver toxicity
Ref: RAPT Therapeutics | Image: RAPT Therapeutics
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
