- Verve Therapeutics ( NASDAQ: VERV ) said the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) clearance its application to start a trial of its gene editing medicine VERVE-101 to treat patients with heterozygous familial hypercholesterolemia (HeFH).
- HeFH is a genetic disorder characterized by elevated levels of low-density lipoprotein (LDL) cholesterol (LDL-C), also known as bad cholesterol. Familial hypercholesterolemia increases the risk of hardening of the arteries (atherosclerosis), which can lead to heart attacks, and other vascular conditions.
- VERVE-101 is an investigational gene editing medicine designed to be a single-course treatment that permanently turns off the PCSK9 gene in the liver to reduce disease-driving LDL-C, the company said in a Sept. 21 press release.
- Clinical Trial Authorization (CTA) in the U.K., is part of a global regulatory strategy, which includes a cleared CTA in New Zealand and expected regulatory clearance of an investigational new drug application in the U.S. in H2 2022 for VERVE-101.
- Verve is currently enrolling patients in a trial called heart-1 of VERVE-101 for HeFH in New Zealand and expects to begin enrolling patients in the U.K. imminently.
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Verve gets clearance in UK to start trial of gene editing therapy for cholesterol disorder