Larimar Therapeutics Shares Rise 10% After FDA Clears CTI-1601 Trial
July 25 2023 - 1:06PM
Dow Jones News
By Chris Wack
Larimar Therapeutics shares were up 10% at $3.44 after the U.S.
Food and Drug Administration cleared the company's Phase 2
dose-exploration trial of CTI-1601 in patients with Friedreich's
ataxia.
The trial will now proceed to a 50-mg cohort, in which
participants will be dosed daily for the first 14 days, and then
every other day until day 28.
The biotechnology company's open label extension trial was also
cleared for initiation by the FDA. Participants in the extension
trial will receive 25 mg of CTI-1601 daily.
CTI-1601 is a novel protein replacement therapy designed to
deliver frataxin to the mitochondria of patients with FA who have
low levels of frataxin.
Data from the previous Phase 2 trial's completed the 25 mg
cohort, and indicated that CTI-1601 was generally well tolerated
and showed increases in frataxin levels from baseline.
CTI-1601 has been granted Orphan Drug, Rare Pediatric Disease,
Fast Track and PRIME designations for FA.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 25, 2023 12:51 ET (16:51 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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