November 7, 2022 10:01am
VERVE-101 Investigational New Drug Application (IND) placed on HOLD by U.S. FDA
Verve submitted its IND application for VERVE-101 to the FDA in October and received notification of a hold from the FDA on Friday, 11/4/22. VERV expects to receive an official letter with the FDA’s questions within 30 days.
However, dosing was completed in First Dose Cohort of the heart-1 Clinical Trial of VERVE-101 in patients with HeFH; Independent Data Safety Monitoring Board Recommended Proceeding to Second Dose Level in New Zealand and U.K.
The independent Data Safety Monitoring Board (DSMB) has reviewed safety data from the first cohort and recommended dose escalation to the planned second dose level, which is expected to begin soon.
The Bottom Line: NOT a good omen for gene editing companies as the …
- FDA has placed a hold on its IND application to conduct a clinical trial evaluating VERVE-101 in patients with heterozygous familial hypercholesterolemia (HeFH), a prevalent and potentially life-threatening subtype of atherosclerotic cardiovascular disease (ASCVD), high cholesterol in the United States.
VERV has already begun human tests in New Zealand and the U.K., says it will likely receive the FDA's questions within a month.