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Larimar Therapeutics Provides Updates on CTI-1601 Clinical Program Following a Type C Meeting with the U.S. Food and Drug Administration and Reports Second Quarter 2022 Operating and Financial Results
Larimar plans to submit a complete response to CTI-1601’s clinical hold in the third quarter of 2022In conjunction with the complete response, Larimar is
About this update from Larimar Therapeutics, Inc.
[{"type":"text","content":"Larimar plans to submit a complete response to CTI-1601’s clinical hold in the third quarter of 2022In conjunction with the complete response, Larimar is proposing a Phase 2, four-week dose exploration study in Friedreich’s ataxia (FA) patients as CTI-1601’s next clinical trialCash and marketable debt securities at June 30, 2022 of $54.9 million provides projected cash runway through the third quarter of 2023 BALA CYNWYD, Pa., Aug. 11, 2022 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that it has received meeting minutes from the U.S. Food and Drug Administration (FDA) following a recent Type C Meeting with the Agency and reported its second quarter 2022 operating and financial results. The purpose of the Type C Meeting was to obtain FDA feedback on the information needed to resolve CTI-1601's current clinical hold in full or in part, as well as to discuss a proposed change in CTI-1601’s clinical development plan to introduce a Phase 2 dose exploration study to precede initiation of an open label extension study. The Company plans to submit a complete response to the CTI-1601 clinical hold in the third quarter of 2022. In conjunction with the complete response, Larimar is proposing as CTI-1601’s next clinical trial a Phase 2, four-week dose exploration study in FA patients starting at the lower dose levels tested in the Company’s Phase 1 multiple-ascending dose clinical trial. This study will provide data on extended dosing of lower doses of CTI-1601, including additional data on safety and tolerability as well as whether lower doses for longer periods of time can increase frataxin levels while maintaining acceptable exposures. Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar, commented, “We would like to thank the FDA for a productive Type C Meeting, which informed the preparation and planned submission of a complete response that we believe will enable CTI-1601’s return to the clinic. We look forward to receiving FDA feedback on the complete response and our proposed Phase 2 dose exploration study. The proposed study has been designed to provide additional information on CTI-1601’s safety profile as well as pharmacokinetic and pharmacodynamic profiles, which we ...