Larimar Therapeutics Announces FDA has Partially Lifted the Clinical Hold and Plans for a Phase 2 Dose Exploration Trial of CTI-1601 in Friedreich’s Ataxia Patients
The FDA has cleared the initiation of a 25 mg cohort of Phase 2, a four-week, placebo-controlled, dose exploration trial of CTI-1601 in Friedreich’s ataxia patients. In a written communication to Larimar, the FDA indicated it was lifting its full clinical hold on the CTI-1601 program and imposing a partial hold. The FDA will review data from the 25 mg cohort prior to escalating the dose in the second cohort. Larimar expects to begin the Phase 2 trial in Q4 2022.
Larimar’s upcoming Phase 2 trial is designed to characterize CTI-1601’s safety further, pharmacodynamic (PD), and pharmacokinetic (PK) profiles to provide information about the preferred long-term dose and dose regimen. Eligible patients will include ambulatory and non-ambulatory individuals with F A who are at least 18 years old.