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Clinical Hold Halts Larimar’s Friedrich’s Ataxia Candidate And Financing

 
• By Joseph Haas

Looking to develop the first drug therapy for FA, Larimar gets US FDA hold due to deaths in non-human primate study. This alters clinical development timelines and fundraising plans for the firm.

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Larimar faces clinical hold for its Friedrich's ataxia candidate

What looked like increasing momentum for Larimar Therapeutics, Inc.’s program to develop the first drug therapy for Friedrich’s ataxia was dashed at least temporarily on 25 May, as the company announced a US Food and Drug Administration clinical hold due to deaths in a non-human primate toxicology study. The news came two weeks after the release of Phase I clinical data the company said showed proof-of-concept and days after it announced a $95m follow-on financing – which is now on hold as well.

The FDA hold on CTI-1601 – a recombinant fusion protein that delivers frataxin, a protein deficient in FA patients, to a patient’s mitochondria – prevents Larimar from initiating planned clinical trials

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