Larimar Therapeutics Shares Rise 10% After FDA Clears CTI-1601 Trial

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 [e-mail]

(END) Dow Jones Newswires

July 25, 2023 12:51 ET (16:51 GMT)

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