Larimar Therapeutics: FDA Cleared New Cohort of CTI-1601 to Treat Friedreich's Ataxia
14 Septembre 2022 - 1:59PM
Dow Jones News
By Dean Seal
Larimar Therapeutics Inc. said Wednesday it has been cleared by
regulators to launch a 25-milligram cohort of a Phase 2 trial
studying its CTI-1601 treatment for Friedreich's ataxia.
The clinical-stage biopharmaceutical company said the Food and
Drug Administration cleared the cohort's initiation by lifting a
full clinical hold and imposing a partial hold.
The program was previously placed on hold by the FDA after the
company flagged three mortalities of 34 animals given CTI-1601 in a
26-week non-human primate toxicology study. All three deaths were
in the study's two highest-dose groups.
The FDA decided to allow the upcoming Phase 2 trial after
Larimar submitted a detailed analysis of its toxicology studies and
Phase 1 clinical trials.
The trial is expected to start in the fourth quarter of this
year, with top-line data expected in the second half of next
year.
Shares edged 2.2% higher to $3.22 in premarket trading.
Friedreich ataxia is a rare inherited disease that causes
progressive nervous system damage and movement problems. It usually
begins in childhood and leads to impaired muscle coordination that
worsens over time, according to the National Institutes of
Health.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
September 14, 2022 07:44 ET (11:44 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
Larimar Therapeutics (NASDAQ:LRMR)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Larimar Therapeutics (NASDAQ:LRMR)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024
