Verve Therapeutics (NASDAQ:VERV) has announced a temporary halt to enrollment in its Heart-1 Phase 1b clinical trial of VERVE-101, due to transient asymptomatic laboratory abnormalities observed in a recently dosed participant.
Despite this setback, the company received clearance for clinical trial applications for its next candidate, VERVE-102, in both the U.K.and Canada, with the Heart-2 Phase 1b clinical trial expected to begin in the second quarter of the year.
The decision to pause the VERVE-101 trial comes after a participant experienced grade 3 transient increases in serum alanine aminotransferase and thrombocytopenia shortly after dosing.
Although these abnormalities resolved within a few days without further symptoms, Verve is investigating these lab abnormalities and will consult with regulatory authorities to chart a path forward for the trial.
Meanwhile, Verve's development focus shifts to VERVE-102, which incorporates a different lipid nanoparticle delivery system and has shown promise in its preclinical trials.