Vtv Therapeutics (VTVT) said Monday that the US Food and Drug Administration has lifted a clinical hold on its cadisegliatin clinical program, including a phase 3 trial in type 1 diabetes.
The company said it plans to resume the trial after submitting a protocol amendment to reduce its duration from 12 months to 6 months, accelerating the initiation of more extensive pivotal studies for a future marketing submission.
The primary endpoint of assessing certain hypoglycemia rates at 6 months will remain unchanged, Vtv Therapeutics said.
The biopharmaceutical company said the FDA imposed a clinical hold last July due to an unresolved chromatographic signal in a study, and that the hold was lifted after it submitted a response confirming the signal was an experimental artifact.
Shares were over 13% higher in recent premarket activity.
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