Verve Therapeutics has received FDA Fast Track designation for VERVE-102, an investigational base editing medicine targeting PCSK9 for treating hyperlipidemia patients with high cardiovascular risk. VERVE-102 is designed as a single-course treatment to permanently deactivate the PCSK9 gene in the liver and reduce LDL-C levels.
The treatment is currently in Phase 1b Heart-2 clinical trial, evaluating safety and tolerability in patients with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD). The company plans to announce initial safety and efficacy data from the first three dose cohorts (0.3, 0.45, and 0.6 mg/kg) in Q2 2025.
The Fast Track status may enable more frequent FDA communications and potential Priority Review. Verve plans to report final dose escalation data, deliver the opt-in package to Eli Lilly, and begin Phase 2 trials in H2 2025.
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