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Verve Therapeutics Pauses Heart-1 Trial After Serious Adverse Events; Shares Fall Pre-Bell
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Verve Therapeutics Pauses Heart-1 Trial After Serious Adverse Events; Shares Fall Pre-Bell
Apr 2, 2024 5:48 AM

08:17 AM EDT, 04/02/2024 (MT Newswires) -- Verve Therapeutics ( VERV ) said Tuesday it paused enrollment for its Heart-1 phase 1b clinical trial after one of its dosed patients experienced serious adverse events.

Shares of the company fell more than 34% in recent premarket activity on Tuesday.

The Heart-1 trial is an open-label phase 1b trial designed to evaluate the safety and tolerability of VERVE-101, which is intended for the treatment of heterozygous familial hypercholesterolemia, an inherited genetic disorder that causes dangerously high cholesterol levels, which can lead to heart disease, heart attack or stroke.

The patient of concern saw a dangerous drug-induced increase in a certain liver enzyme, as well as thrombocytopenia, an abnormal drop in blood platelets, within the first four days after dosing with VERVE-101.

"The participant did not experience any bleeding or other symptoms related to the laboratory abnormalities, and the abnormalities resolved fully within a few days," the company said, adding that it is conducting an investigation into the laboratory abnormalities related to the incident.

Verve also said it is now prioritizing the development of VERVE-102 and the launch of Heart-2 trial. It said it has received regulatory clearances for Heart-2 trial in the UK and Canada and plans to launch the trial in patients with heterozygous familial hypercholesterolemia or premature coronary artery disease in Q2.

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