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Larimar Therapeutics Reports Third Quarter 2021 Operating and Financial Results
BALA CYNWYD, Pa., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on
About this update from Larimar Therapeutics, Inc.
[{"type":"text","content":"BALA CYNWYD, Pa., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its third quarter and year to date September 30, 2021 operating and financial results. “We are advancing towards 2022 with a strong balance sheet, the backing of high-quality institutional investors, and compelling Phase 1 data that demonstrate proof-of-concept for CTI-1601,” said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. “We continue to collect and analyze data from our 180-day non-human primate toxicology study so that we can continue moving towards the resolution of CTI-1601’s clinical hold and an expected return to the clinic in the first half of next year. We are working expeditiously towards this goal, as patients with Friedreich’s ataxia (FA) urgently need disease-modifying therapies. With a differentiated mechanism of action targeting the root cause of FA, we believe CTI-1601 is uniquely positioned to potentially address this need and look forward to its continued clinical development.” Third Quarter 2021 Highlights Prior to the third quarter, the United States Food and Drug Administration (FDA) placed a clinical hold on the CTI-1601 clinical program after Larimar notified the agency of mortalities that occurred at the highest dose levels of a 180-day non-human primate (NHP) toxicology study designed to support extended dosing of patients with CTI-1601. In the clinical hold letter, the FDA stated that it needs a full study report from the NHP study and that Larimar may not initiate additional clinical trials until the Company has submitted the report and received notification from the agency that additional clinical trials may commence. At the time of the notice, the Company had no interventional clinical trials with patients enrolled or enrolling.In July 2021, Larimar completed dosing in the 180-day NHP toxicology study, and it continues to collect and analyze data. While there is no way to predict the FDA’s response (which the Company anticipates will not be received prior to the first quarter of 2022) or whether they will require additional data or testing before lifting the clinical hold on CTI-1601 in full or in part, the Company expects to initiate its Jive open-label...