FDA Places Hold on Verve’s IND for Gene-Editing Candidate
The FDA has placed a hold on Verve Therapeutics’ Investigational New Drug (IND) application to conduct a clinical trial evaluating the company’s VERVE-101 gene editing treatment to inactivate a specific gene in the liver and reduce low-density lipoprotein cholesterol.
The therapy candidate is targeted to treat patients with heterozygous familial hypercholesterolemia, an inherited genetic disorder that causes hardening of the arteries.
VERVE-101 is being evaluated in a phase 1 trial in the UK and New Zealand. So far, dosing has been completed in the first cohort of the dose-escalation portion of the clinical trial.
Verve said that it did not include the data from the ongoing study in its IND application to the FDA. The company is awaiting details from the agency on what’s needed for the study to go ahead.