The company said it received feedback from the FDA on information needed to resolve CTI-1601's current clinical hold, as well as a proposed change for a second phase. CTI-1601 is a treatment for Friedreich's ataxia.
Larimer plans to submit a complete response to CTI-1601's clinical hold in the third quarter.
Larimar is also proposing a phase two, four-week dose exploration study in Friedreich's ataxia patients. Friedreich's ataxia is a rare disease that causes progressive nervous system damage and movement problems, usually beginning during childhood.