Iryna Drozd
- VTv Therapeutics (NASDAQ:VTVT) said the FDA has placed a clinical hold on its cadisegliatin clinical program, which includes the CATT1 Phase 3 study of the product for the treatment of type 1 diabetes.
- The biotech company said the hold was placed “based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion study of cadisegliatin that could not be resolved by standard mass spectroscopy.”
- VTv (VTVT) added that the FDA is requiring a single in vitro study be conducted to characterize the signal before the program can resume, according to a statement.
- The company said the hold was placed before patients had been dosed in the CATT1 study.
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