- That The FDA has approved the initiation from Larimar Therapeutics Inc LRMR 25 mg cohort of the phase 2 study of CTI-1601 in patients with Friedreich’s ataxia.
- In a written notice to Larimar, the FDA indicated that it is releasing the full clinical lockdown on the CTI-1601 program and imposing a partial lockdown.
- The design of the upcoming Phase 2 study is identical to the design proposed by Larimarexcept for the requirement for the FDA to review data from the 25 mg cohort before escalating the dose in the second cohort.
- Larimar anticipates that the Phase 2 trial will begin in Q4 2022 with top-line data expected in H2 2023.
- The CTI-1601 program was taken to hospital after three deaths of 34 animals in a 26-week non-human primate (NHP) toxicology study designed to support prolonged dosing of patients with CTI-1601.
- All 3 of these NHPs were in the two highest dose groups in the study, and all NHPs in the two lower dose groups survived to the end of the study.
- To support the development of CTI-1601, Larimar has made an underwritten offering of 22.22 million shares at a price of $3.15 Gross proceeds of $70 million.
- Underwriters have the option to purchase up to an additional 3.33 million shares.
- Price promotion: LRMR shares are up 1.27% to $3.19 during the market session last check Wednesday.
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