Verve Therapeutics (VERV) said Monday its investigational new drug application for Verve-102 has been cleared by the US Food and Drug Administration to treat heterozygous familial hypercholesterolemia and/or premature coronary artery disease.
Verve-102 is an investigational in vivo base editing medicine that inactivates the PCSK9 gene in liver to reduce blood low-density lipoprotein cholesterol designed to be effective in one course of treatment, the company added.
The regulator's decision was based on the company's interim clinical data from the dose-escalation part of the current Heart-2 phase 1b clinical study for Verve-102, Verve said, adding that it intends to report demographic and initial safety and efficacy data from the Heart-2 clinical trial in Q2.
The company expects to post final data for the dose escalation portion of the Heart-2 clinical trial in H2.
Verve's stock was up 1.1% in recent Monday premarket activity.
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