NervGen Pharma aligns with FDA on RESTORE study following End-of-Phase 2 meeting

NervGen Pharma (NGEN) announced the completion of an End-of-Phase 2 meeting with the FDA and alignment on RESTORE, the company’s Phase 3 registrational study designed to evaluate NVG-291 for the treatment of chronic tetraplegia. The RESTORE registrational study remains on-track for initiation in mid-2026, with study initiation activities underway. Data from the randomized, placebo-controlled Phase 1b/2a CONNECT SCI study in chronic tetraplegia supports the RESTORE registrational study design, including endpoint selection, timing of assessments, and dosing regimen. A mean improvement of +3.7 points at Week 12 in NVG-291-treated subjects versus +0.4 points for placebo-treated subjects, exceeding the 2.0-point minimally important difference. Continued improvement in GRASSP QtP to +4.4 points for NVG-291-treated subjects versus +1.2 points for placebo-treated subjects, demonstrating a sustained treatment effect at Week 16, four weeks after treatment cessation. 75% of NVG-291-treated subjects reported being “much” or “very much” improved versus 33% of placebo-treated subjects, reinforcing the relevance of observed functional gains. Blinded qualitative interviews conducted up to 364 days post-study contextualized systemic improvements, including 67% of NVG-291-treated subjects reporting improved bladder control and 56% reporting reduced muscle spasticity. Favorable safety and tolerability across 12 weeks of daily subcutaneous dosing of NVG-291, with no treatment-related serious adverse events or treatment discontinuations. Following a successful EOP2 meeting and FDA alignment across the proposed study parameters of RESTORE, NervGen has elected to conclude enrollment in the Phase 1b/2a CONNECT SCI study in subacute tetraplegia and unblind available data. FDA alignment on the RESTORE registrational study design emphasizes clinical endpoints that capture how individuals with chronic tetraplegia function, feel, and succeed in everyday life. The company intends to apply this regulatory alignment and endpoint framework to inform a future registrational-quality study in subacute tetraplegia.