By Sabela OjeaVTv Therapeutics said the U.S. Food and Drug Administration has placed a clinical hold on the cadisegliatin clinical program, which includes the ongoing CATT1 Phase 3 trial in type 1 diabetes. Cadisegliatin is an oral, liver selective, glucokinase activator that has been well-tolerated in over 500 subjects to date with up to six months of treatment. The FDA requires a single in vitro study to characterize this signal before the cadisegliatin program can resume, the company said. "Patient safety is our top priority, and we appreciate the thoroughness of the FDA to better understand this signal. We are working diligently with the Agency to resolve the clinical hold and resume enrollment as quickly as possible," Chief Executive Paul Sekhri said.

Source: Wall Street Journal July 27, 2024 08:43 UTC