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Larimar Therapeutics Reports Fourth Quarter and Full Year 2022 Operating and Financial Results
First cohort of Larimar’s Phase 2 dose exploration trial of CTI-1601 in participants with Friedreich’s ataxia (FA) is fully enrolled and proceeding as
About this update from Larimar Therapeutics, Inc.
[{"type":"text","content":"First cohort of Larimar’s Phase 2 dose exploration trial of CTI-1601 in participants with Friedreich’s ataxia (FA) is fully enrolled and proceeding as plannedLarimar expects to provide an update on the next steps of the Phase 2 trial in Q2 2023, after the FDA and independent data monitoring committee review data from the first cohort and provide feedback to the CompanyTop-line safety, pharmacokinetic, and pharmacodynamic (e.g., frataxin level) data from both of the Phase 2 trial’s planned cohorts expected in 2H 2023 Cash and investments of $118.4 million at December 31, 2022 provides projected cash runway into 2H 2024 BALA CYNWYD, Pa., March 14, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its fourth quarter and full year 2022 operating and financial results. “Our recent progress provides a strong foundation for growth as we work to develop CTI-1601 as the first FA therapy designed to potentially address frataxin deficiency, which is the underlying cause of the disease,” said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. “The first cohort of our Phase 2 trial is fully enrolled, with an update that will outline the next steps for the trial anticipated in the second quarter. We also recently strengthened our balance sheet and leadership team with a financing and the appointment of long-time Johnson & Johnson veteran Dr. Gopi Shankar as our Chief Development Officer. Looking forward, we believe these accomplishments, together with our Phase 1 proof-of-concept data, leave us well positioned to build on our positive momentum as we seek to improve the therapeutic paradigm for patients with FA, who remain in need of a therapy that may address the root cause of the disease by increasing frataxin levels.” 2022 and Subsequent Highlights Larimar recently completed enrollment in the 25 mg cohort of a Phase 2, four-week, placebo-controlled, dose exploration trial of CTI-1601 in participants with FA. The trial was cleared to begin enrollment in this first cohort in September 2022, when the U.S. Food and Drug Administration (FDA) lifted the full clinical hold previously placed on the CTI-1601 program and imposed a partial hold. The initiation of additional cohorts in the...