LEXEO Therapeutics Announces FDA Fast Track Designation Granted to LX1001 for the Treatment of APOE4 Associated Alzheimer’s Disease

LEXEO Therapeutics, a clinical-stage gene therapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LX1001, the company’s adeno-associated virus (AAV) mediated gene therapy program, for the potential treatment of apolipoprotein E4 (APOE4) associated Alzheimer’s disease. LX1001 is a CNS-administered therapy being evaluated in an ongoing Phase 1 clinical trial.

“The Fast Track designation granted by the FDA will expedite the development and review of LX1001 and we look forward to working closely with the Agency moving forward as we continue to advance this transformational gene therapy,” said R. Nolan Townsend, Chief Executive Officer of LEXEO Therapeutics. “While other treatments in development focus on the pathogenesis of Alzheimer’s disease, LX1001 is the first investigational gene therapy designed to correct the underlying genetics of the disease thereby addressing the most significant risk factor for developing Alzheimer’s disease.”

Alzheimer’s disease is the leading cause of late life mental failure in humans. APOE is the major transporter of cholesterol in the brain with prevailing evidence suggesting that it is a major genetic risk factor in the pathogenesis of the disease. Inheritance risk for APOE4 results in more frequent and earlier age of onset for developing Alzheimer’s disease while inheritance of APOE2, a protective APOE gene variant, has the reverse effect. LX1001 is an AAV mediated gene therapy being developed to deliver the protective APOE2 gene to the central nervous system.

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