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LEXEO Announces FDA Clearance of IND Application for LX2006 for Friedreich’s Ataxia Cardiomyopathy

LEXEO Therapeutics Announces FDA Clearance of Investigational New Drug Application for LX2006, an AAV-based Gene Therapy Candidate for Friedreich’s Ataxia Cardiomyopathy

- Phase 1/2 clinical trial expected to initiate in mid-2022 -

- LX2006 is the first clinical-stage program from LEXEO’s cardiovascular pipeline and the third clinical-stage gene therapy candidate across its pipeline -

NEW YORK – February 16, 2022 (GLOBE NEWSWIRE) – LEXEO Therapeutics (LEXEO), a clinical-stage gene therapy company advancing a diverse pipeline of adeno-associated virus (AAV)-based gene therapy candidates for genetically defined cardiovascular and central nervous system diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for LX2006. LX2006 is an AAV-based gene therapy candidate designed to intravenously deliver a functional frataxin gene, for the treatment of Friedreich’s ataxia cardiomyopathy (FA cardiomyopathy). LEXEO plans to initiate this open-label, dose-escalation Phase 1/2 clinical trial of LX2006 in patients with FA cardiomyopathy in the middle of 2022.   More...

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