Accept Cookies?
Provided by OpenGlobal E-commerce

Please wait while your page loads ...

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 25 mg cohort of a Phase 2, four-week, placebo-controlled, dose exploration trial of CTI-1601 in Friedreich’s ataxia (FA) 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 further characterize CTI-1601’s safety, 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 FA who are at least 18 years old.

Click here for the full press release which contains additional background and information on this program:

FARA is working with Larimar to host a webinar with Larimar Therapeutics for the patient community next week. We will share date and time and registration details in the next few days.
 
 


SHARE
 

Scientific News Archives

Tagged in
Scientific News

Beaker

Privacy Policy      Service Terms      Contact      Charity Navigator