NervGen Pharma (NASDAQ:NGEN), a clinical-stage biotech company dedicated to developing innovative solutions for the treatment of nervous system repair, has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), gaining alignment on the design of its Phase 3 registrational study, RESTORE.
The upcoming study will evaluate the safety and efficacy of NVG-291, a first-in-class therapeutic designed to enable nervous system repair by inhibiting protein tyrosine phosphatase sigma (PTPσ).
The RESTORE trial is designed as a randomized, double-blind, placebo-controlled Phase 3 study focusing on approximately 150 subjects with chronic tetraplegia resulting from spinal cord injury (SCI).
The trial will involve daily subcutaneous dosing for 12 weeks, followed by a four-week observational period.
To ensure robust data collection, NervGen plans to activate up to 60 clinical sites across the United States and Canada.
The primary endpoint for the study is the change from baseline in the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) Quantitative Prehension (QtP) score at Week 12.
The Phase 3 design was informed by promising results from the Phase 1b/2a CONNECT SCI trial.
In that study, patients treated with NVG-291 showed a mean improvement of +3.7 in the GRASSP QtP score at Week 12, compared to just +0.4 in the placebo group—a treatment difference of +3.3.
Furthermore, the therapy demonstrated a favorable safety profile with no treatment-related serious adverse events reported.
NervGen confirmed that the initiation of the RESTORE trial remains on track for mid-2026.
The study protocol also includes an optional 12-week open-label extension for subjects initially assigned to the placebo arm, allowing all participants the opportunity to receive the investigational drug.