VERV Stock Soars on Superior Efficacy in Phase I Cholesterol Study

Core Viewpoint - Verve Therapeutics' shares increased by 26.4% following the announcement of positive initial data from the early-stage study of VERVE-102, a candidate aimed at reducing cholesterol levels [1] Group 1: Study Details - The phase Ib Heart-2 study includes patients with heterozygous familial hypercholesterolemia and/or premature coronary artery disease, both of which require significant reductions in low-density lipoprotein cholesterol (LDL-C) levels [2] - The data readout involved 14 patients from the first three cohorts who received doses of VERVE-102 at 0.3 mg/kg, 0.45 mg/kg, or 0.6 mg/kg, with each participant having at least 28 days of follow-up as of March 13, 2025 [3] Group 2: Efficacy Results - A single infusion of VERVE-102 led to dose-dependent reductions in blood PCSK9 protein levels and LDL-C, with an average LDL-C decrease of 53% and a maximum reduction of 69% in the 0.6 mg/kg cohort [4] - In cohort 1, patients receiving 0.3 mg/kg showed a 21% reduction in LDL-C and a 46% reduction in PCSK9; those receiving 0.45 mg/kg had a 41% reduction in LDL-C and a 53% reduction in PCSK9; and in cohort 3, the reductions were 53% in LDL-C and 60% in PCSK9 [5][7] Group 3: Safety and Next Steps - VERVE-102 was well-tolerated across all doses, with no serious adverse events reported and no significant changes in liver enzymes or other clinical parameters among participants [7] - The Heart-2 study is currently enrolling participants for a fourth dose cohort of 0.7 mg/kg, with early safety findings consistent with previous cohorts; final data from the dose escalation phase is expected in the second half of 2025 [8] - A phase II clinical study for VERVE-102 is planned to begin in the second half of 2025, following FDA clearance of its investigational new drug application [9] Group 4: Collaboration and Future Plans - Verve Therapeutics has a collaboration agreement with Eli Lilly for the PCSK9 program, where Lilly can opt in to share development costs and profits; Verve retains control over development and commercialization in the U.S. [11] - The company plans to submit the opt-in package to Eli Lilly and expects a decision in the second half of 2025 [11]