Verve Therapeutics receives information from FDA regarding clinical hold

Verve Therapeutics disclosed that on December 2, it received a clinical hold letter from the Food and Drug Administration that outlined the information required to resolve the clinical hold, including additional preclinical data relating to: potency differences between human and non-human cells, risks of germline editing, and off-target analyses in non-hepatocyte cell types. The FDA also requested available clinical data from the ongoing heart-1 trial. In addition, the FDA has requested that Verve modify the trial protocol in the United States to incorporate additional contraceptive measures and to increase the length of the staggering interval between dosing of participants. Verve intends to submit a response "as expeditiously as possible." It added, "Verve continues to enroll patients in the heart-1 clinical trial in New Zealand and the United Kingdom and plans to report initial safety and pharmacodynamic data from the dose-escalation portion of the heart-1 trial in the second half of 2023." As previously announced, Verve was informed on November 4 by the FDA that its IND application to conduct a clinical trial in the United States evaluating VERVE-101 in patients with heterozygous familial hypercholesterolemia, a prevalent and potentially life-threatening subtype of atherosclerotic cardiovascular disease, had been placed on hold.