Shares of Verve Therapeutics, Inc. (VERV) were gaining around 30 percent in the pre-market activity on the Nasdaq, after the clinical-stage company focused on genetic medicines for cardiovascular disease announced Monday positive initial data from the Heart-2 Phase 1b clinical trial of VERVE-102.
In its statement, the company noted that its Heart-2 Phase 1b clinical trial is evaluating patients with heterozygous familial hypercholesterolemia or HeFH and/or premature coronary artery disease or CAD, two populations that require deep and durable reductions of low-density lipoprotein cholesterol or LDL-C levels in the blood.
VERVE-102 is a novel, in vivo, investigational base editing medicine designed to be a single-course treatment that permanently turns off the PCSK9 gene in the liver and durably reduces disease-driving LDL-C.
In the second half of 2025, the company expects to report final Heart-2 dose escalation data, dose the first patient in a Phase 2 clinical trial for VERVE-102, and receive a decision from Eli Lilly and Co. (LLY) for the PCSK9 opt-in.
Under the PCSK9 program collaboration agreement with Verve, Eli Lilly holds the right to opt-in to share worldwide development expenses, 33% contributed by Lilly, and to jointly commercialize and share profits and expenses related to commercialization in the U.S. on a 50/50 basis.
Verve retains control of the development and commercialization of all collaboration products in the U.S., and Verve holds all product rights outside the U.S.
The Heart-2 clinical trial is an open-label Phase 1b clinical trial designed to evaluate the safety and tolerability of VERVE-102 administration in adult patients with HeFH and/or premature CAD who require additional lowering of LDL-C.
In the Heart-2 Phase 1b clinical trial, VERVE-102 was well-tolerated among 14 participants across three dose levels, with no treatment-related serious adverse events or SAEs and no clinically significant laboratory abnormalities observed.
The company further said that the Heart-2 clinical trial is expected to include four dose cohorts, each comprised of three to nine participants with HeFH and/or premature CAD.
In pre-market activity on the Nasdaq, Verve shares were trading at $4.25, up 30.4 percent.
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