Business
Larimar Therapeutics Reports Fourth Quarter and Full Year 2021 Operating and Financial Results
BALA CYNWYD, Pa., March 25, 2022 (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., March 25, 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 full year 2021 operating and financial results. “The past year was highlighted by our first clinical data readouts, which demonstrated the potential of CTI-1601 to address the root cause of Friedreich’s ataxia by increasing frataxin levels in patients,” said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. “With these important proof-of-concept data in hand, we continue to work expeditiously to identify the best path forward through the resolution of CTI-1601’s clinical hold. Our commitment to furthering CTI-1601’s development remains steadfast, and the urgent unmet needs of patients with Friedreich’s ataxia continue to inspire us. We look forward to our continued progress and would like to thank all those who played a role in the advancement of our Phase 1 program over the past year including our clinical trial participants, their families, and members of the Friedreich’s Ataxia Research Alliance.” 2021 and Subsequent Highlights In May 2021, Larimar reported positive topline data from its Phase 1 Friedreich’s ataxia (FA) program. These data, which were from single- and multiple ascending dose trials in FA patients, demonstrated proof-of-concept by showing that daily subcutaneous injections of CTI-1601 for up to 13 days resulted in dose-dependent increases in frataxin levels from baseline compared to placebo in all evaluated tissues (buccal cells, skin, and platelets). Frataxin levels achieved in peripheral tissues (buccal cells) following daily 50 mg and 100 mg subcutaneous injections of CTI-1601 were similar to or exceeded frataxin levels that would be expected in phenotypically normal heterozygous carriers. The data also show that CTI-1601 was generally well tolerated at doses up to 100 mg administered daily for up to 13 days, as there were no serious adverse events (SAEs) associated with either of the Phase 1 trials.In May 2021, Larimar received a European Medicines Agency (EMA) Priority Medicines (PRIME) designation for CTI-1601 in FA. Through PRIME, the EMA offers early and proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefi...