NurExone Announces Clinical Trial Plans for Acute Spinal Cord Injury Therapy at Annual Meeting of American Spinal Injury Association

Core Insights - NurExone Biologic Inc. is advancing its first-in-class exosome-based therapy, ExoPTEN, for acute spinal cord injuries, with plans to initiate a Phase 1/2a clinical trial in 2026 [2][6][11] - The company will present updates on its clinical plans and preclinical study results at the upcoming American Spinal Injury Association meeting [4][8] Company Developments - Professor Nahshon Knoller, a senior clinical advisor, will discuss the 2026 SCI Trial and preclinical results at the ASIA meeting [4][5] - The 2026 SCI Trial will enroll adult patients with traumatic spinal cord injuries classified as ASIA Grade A or B, treating them within 3 to 7 days post-injury [3][6] - The trial will consist of a Phase 1 dose-escalation study for safety in up to 18 patients, followed by a Phase 2a randomized, double-blind, placebo-controlled trial measuring functional recovery in 10-15 patients [3] Product and Technology - ExoPTEN is based on mesenchymal stem cell-derived exosomes loaded with siRNA targeting PTEN, aimed at reducing cell death and promoting axonal regrowth [6][11] - The therapy has received Orphan Drug Designation from both the FDA and EMA, facilitating its clinical trial roadmap [6][11] - Preclinical studies have shown robust recovery of motor, sensory, and structural functions in rat models, confirming the therapeutic effects of ExoPTEN [7][11] Market Context - The company is positioned in the multi-billion-dollar markets for treating acute spinal cord and optic nerve injuries [11] - NurExone has established a U.S. subsidiary, Exo-Top Inc., to support its North American growth strategy [11]