LRMR - Larimar Therapeutics' Friedreich's Ataxia Investigational Drug Differentiated From Biogen's Marketed Drug | Benzinga
On Monday, Larimar Therapeutics Inc (NASDAQ:LRMR) announced that the FDA removed the previous partial clinical hold on -nomlabofusp (CTI-1601) clinical program for Friedreich’s Ataxia (FA).
Nomlabofusp is a novel protein replacement therapy designed to address the root cause of FA by delivering frataxin to mitochondria.
The FDA removed the partial clinical hold after reviewing data from the company’s recently completed Phase 2 dose exploration study.
The review included data from 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.
In the Phase 2 dose exploration study, nomlabofusp was generally well-tolerated throughout the four-week treatment period.
Nomlabofusp had a predictable pharmacokinetic profile and ...