STAT+: FDA clears Verve to begin U.S. study of gene-editing treatment for high cholesterol
Verve Therapeutics said Monday that it had received clearance from the Food and Drug Administration to conduct a clinical trial in the U.S. of its experimental, gene-editing treatment for a common form of heart disease.
The FDA’s action removes a clinical hold on Verve’s CRISPR-based therapy, called VERVE-101, that was placed on it last November. Verve now intends to recruit participants from U.S. sites into a Phase 1 study that’s been underway since last year in New Zealand and the United Kingdom.
“We’re thrilled to get this clearance for VERVE-101,” said Verve CEO Sek Kathiresan. “Our study is called HEART-1 and our plan now is to activate U.S. sites.”
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