Lexeo receives FDA Fast Track and Orphan Drug designations for gene therapy LX2020 in PKP2-ACM

Lexeo Therapeutics, Inc.

FDA granted Fast Track and Orphan Drug designations for LX2020, an AAVrh10 gene therapy for PKP2-ACM.
No approved treatments exist for PKP2-ACM, a prevalent genetic cardiovascular disease.
LX2020 delivers a functional PKP2 gene intravenously to cardiac muscle as a one-time infusion.
Planned Phase 1/2 HEROIC-PKP2 trial: 52-week, open-label, dose-escalating, multicenter with two cohorts (2.0x10^13 and 6.0x10^13 vg/kg).
Orphan Drug offers market exclusivity and tax credits; Fast Track enables expedited FDA review.

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