Verve Therapeutics Gets Clinical Hold For VERVE-101 Lifted By FDA
23 Oktober 2023 - 1:22PM
Dow Jones News
By Chris Wack
Verve Therapeutics said Monday that the clinical hold and
clearance of its Investigational New Drug application by the U.S.
Food and Drug Administration has been lifted, allowing it to
conduct a clinical trial in the U.S. evaluating VERVE-101 for the
treatment of heterozygous familial hypercholesterolemia.
VERVE-101 is an investigational, in vivo base editing medicine
designed to be a single-course treatment that inactivates the PCSK9
gene in the liver to durably lower blood low-density lipoprotein
cholesterol.
The biotechnology company said it submitted interim clinical
data from the dose-escalation portion of the ongoing heart-1 Phase
1b clinical trial and addressed the FDA's preclinical questions in
its response to the clinical hold.
The heart-1 trial is evaluating the safety, tolerability,
pharmacokinetic and pharmacodynamic profile of VERVE-101 in
patients with HeFH, and is currently being conducted at sites in
the U.K. and New Zealand.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 23, 2023 07:07 ET (11:07 GMT)
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