Lexeo Gets FDA Fast-Track Designation for LX2006 in Friedreich's Ataxia Cardiomyopathy

By Colin Kellaher

Lexeo Therapeutics has won U.S. Food and Drug Administration fast-track designation for its LX2006 gene therapy candidate for the most common cause of death in people with a rare genetic neuromuscular disorder.

Lexeo on Tuesday said the designation covers LX2006 in the treatment of cardiomyopathy in patients with Friedreich's ataxia, an inherited disorder that causes progressive damage to the nervous system.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Lexeo, which previously won FDA rare-pediatric-disease and orphan-drug designations for LX2006 in the treatment of Friedreich's ataxia cardiomyopathy, said it is currently conducting a Phase 1/2 study to evaluate the safety, tolerability and preliminary efficacy of the gene therapy.

The New York clinical-stage genetic-medicine company said there are currently no FDA-approved treatment options for Friedreich's ataxia cardiomyopathy.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

April 16, 2024 08:04 ET (12:04 GMT)

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