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Lexeo Therapeutics Advances Accelerated Pathway for LX2006 in Friedreich Ataxia Cardiomyopathy

13 Oct 2025
Admin
News Article

Lexeo Therapeutics Advances Accelerated Pathway for LX2006 in Friedreich Ataxia Cardiomyopathy

Lexeo Therapeutics, a New York–based genetic medicine company developing treatments for cardiovascular and neurological diseases, announced major regulatory progress for its lead gene therapy candidate LX2006, alongside new interim data from ongoing phase I/II trials.

FDA Opens Door to Accelerated Approval

Following recent discussions with the U.S. FDA, Lexeo has received positive feedback supporting a potentially accelerated approval pathway for LX2006 in Friedreich ataxia (FA) cardiomyopathy.

“The data so far show meaningful improvements across both cardiac and neurological measures. We’re now pursuing a development strategy that could allow a smaller pivotal study — possibly enabling faster submission under the Accelerated Approval pathway.”

R. Nolan Townsend, CEO, Lexeo Therapeutics.

Regulatory Highlights

Pooled data strategy: FDA indicated openness to a BLA submission that combines results from ongoing phase I/II trials with data from an upcoming pivotal study.
Manufacturing upgrade: Lexeo will submit enhanced comparability and nonclinical data to align its new Sf9-baculovirus manufacturing platform with the clinical process used in early studies.
Earlier endpoint assessment: FDA agreed to evaluate LVMI (Left Ventricular Mass Index), a co-primary endpoint, earlier than 12 months, potentially reducing study duration.
Designations secured: LX2006 holds Breakthrough Therapy, RMAT, Orphan Drug, Fast Track, and Rare Pediatric Disease designations. It’s also part of the FDA’s CMC Development and Readiness Pilot (CDRP) program.

Collectively, these updates could reduce the size and length of the upcoming pivotal trial, moving Lexeo closer to its goal of a BLA submission. The pivotal study is expected to begin in the first half of 2026, pending final protocol approval.

About LX2006

LX2006 is an AAV-based gene therapy designed to treat FA cardiomyopathy, the leading cause of death in people with Friedreich ataxia, a condition affecting roughly 5,000 individuals in the U.S.

The therapy delivers a functional frataxin gene to restore mitochondrial function in heart muscle cells. It’s currently being evaluated in two trials:

SUNRISE-FA (NCT05445323): Lexeo-sponsored phase I/II study
Weill Cornell Medicine phase 1A trial (NCT05302271)

Why It Matters?

If successful, LX2006 could become the first gene therapy for FA cardiomyopathy, addressing a life-threatening aspect of a rare genetic disease with no approved treatments today.