Business
Larimar Therapeutics Reports First Quarter 2022 Operating and Financial Results
- CTI-1601 Type C Meeting to discuss clinical hold has been granted by the U.S. Food and Drug Administration and is scheduled for early in the third quarter
About this update from Larimar Therapeutics, Inc.
[{"type":"text","content":"- CTI-1601 Type C Meeting to discuss clinical hold has been granted by the U.S. Food and Drug Administration and is scheduled for early in the third quarter of 2022 - Cash at March 31, 2022 of $62.6 million provides projected cash runway into the third quarter of 2023 BALA CYNWYD, Pa., May 12, 2022 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its first quarter 2022 operating and financial results. “The FDA recently granted our request for a Type C meeting, which is expected to provide an important framework for interactions related to both the hold and our next proposed clinical trial,” said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. “There remains an urgent need for therapies that can slow or prevent the progression of Friedreich’s ataxia, which remains the key motivating factor behind our clinical development efforts. We believe our Phase 1 data demonstrate proof-of-concept for CTI-1601 as a frataxin replacement therapy and its differentiated mechanism of action (MOA). We believe this MOA leaves CTI-1601 uniquely positioned to address the urgent need for disease modifying therapies in Friedreich’s ataxia, as it is designed to address the root cause of this devastating disease. We look forward to its continued development and our upcoming interactions with the FDA.” CTI-1601 Update In February 2022, Larimar received feedback from the U.S. Food and Drug Administration (FDA) regarding the May 2021 clinical hold placed on the CTI-1601 program. The May 2021 hold followed the Company’s notification to the agency of mortalities which occurred at the highest dose levels in a 26-week non-human primate (NHP) toxicology study that was designed to support extended dosing of patients with CTI-1601. At the time the hold was placed, Larimar had no interventional clinical trials with patients enrolled or enrolling. In the feedback provided in February 2022, the FDA stated it was maintaining the clinical hold and that additional data are needed to resolve the clinical hold. This feedback followed Larimar’s submission of a complete response to the agency. Larimar subsequently submitted a request for an FDA Type C meeting, which has been granted and has been scheduled for ea...