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Lexeo Therapeutics (LXEO) investor relations material
Lexeo Therapeutics H. C. Wainwright Genetic Medicines Virtual Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Program updates and clinical progress
Completed enrollment of Phase 1/2 study for Friedreich's ataxia (FA) and moving to a registrational study next year.
Arrhythmogenic cardiomyopathy program to complete Phase 1/2 enrollment this year, with next steps planned for 2026 and beyond.
Recent clinical data in FA show significant improvements in cardiovascular and neurologic endpoints.
All six patients with abnormal LVMI in Phase 1 normalized their heart mass, with some showing up to 50% reduction.
Cardiac gene therapy field is expected to expand rapidly, with AAV vectors seen as leading technology.
Regulatory and trial design insights
Agreement with FDA on an expedited path to accelerated approval for FA, including pooling Phase 1/2 and pivotal data.
FDA open to evaluating endpoints earlier than 12 months, likely shortening pivotal study duration.
Pivotal trial for FA will enroll patients with abnormal LVMI and use mFARS as co-primary endpoints.
Study powered to detect a 10% reduction in LV mass, a clinically meaningful threshold agreed upon with FDA.
Propensity matching and identical inclusion criteria used to ensure comparability between treatment and natural history arms.
Mechanistic and durability considerations
FA cardiomyopathy linked to mitochondrial dysfunction due to frataxin deficiency, leading to increased heart mass.
Therapy aims to restore frataxin, reducing mitochondrial hyperplasia and normalizing heart structure.
Durable gene expression expected in non-dividing cardiac cells, supporting long-term benefit.
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