FDA Removes Partial Clinical Hold for Larimar Therapeutics’ Nomlabofusp Program in Friedreich’s Ataxia

May 21, 2024

DENVER, Colo., May 21, 2024 (247marketnews.com)- Larimar Therapeutics, Inc. (Nasdaq:LRMR) reported that the U.S. FDA removed the partial clinical hold previously placed on the company’s nomlabofusp (CTI-1601) clinical program, after a review of data from the Company’s recently completed four-week, placebo-controlled Phase 2 dose exploration study, which included data from both the 25 mg and 50 mg cohorts in patients who received daily dosing of nomlabofusp for 14 days followed by every other day dosing until day 28.

“We are very excited the FDA has removed the partial clinical hold on our nomlabofusp program following review of our Phase 2 data. Helping patients with FA is our top priority and we appreciate the attention and thorough review by the FDA of all submitted data,” commented Larimar’s President and CEO, Carole Ben-Maimon, MD. “Importantly, we are now cleared to dose escalate to the 50 mg dose in our ongoing OLE study which we plan to do following further characterization of frataxin PD at the 25 mg dose. The OLE study is evaluating the long-term safety as well as frataxin levels following daily administration of nomlabofusp and we look forward to interim data in the fourth quarter of the year.”

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