MIAMI — October 12, 2026
NervGen Inc. announced that the first participant has been dosed in RESTORE, a Phase 3 registrational clinical trial evaluating NVG-291 in adults with chronic cervical motor-incomplete spinal cord injury (SCI). The company anticipates enrolling approximately 150 participants across the United States and Canada, with enrollment completion expected in the second half of 2027 and topline results anticipated in the first half of 2028. The study is designed to evaluate whether NVG-291 can improve hand function and support greater independence and quality of life for individuals living with chronic SCI.
NVG-291 Targets a Neuroreparative Pathway
NVG-291 is an investigational, subcutaneously administered neuroreparative peptide designed to target the inhibitory CSPG-PTPσ pathway. NervGen is developing the candidate to address biological barriers that limit nervous system repair following spinal cord injury. The program builds on findings from the placebo-controlled Phase 1b/2a CONNECT SCI study, which informed the design of RESTORE, including its endpoints, treatment duration and participant-reported assessments. NVG-291 has received Fast Track designation from the U.S. FDA and Orphan Drug designation from the European Medicines Agency for SCI. The candidate remains investigational, and its potential clinical benefits require confirmation in the ongoing registrational study.
RESTORE Evaluates Hand Function and Independence
RESTORE is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of NVG-291 in adults with chronic cervical motor-incomplete SCI. Participants will be randomized in a 1:1 ratio to receive NVG-291 or placebo through once-daily subcutaneous injections for 12 weeks, followed by a four-week observation period. An optional 12-week open-label extension is planned after study completion. The primary endpoint measures improvement in hand function using GRASSP Quantitative Prehension. Secondary endpoints and blinded participant interviews will assess additional aspects of functional independence and quality of life. Eligible participants must be one to ten years post-traumatic SCI, have a motor level at C7 or higher on both sides, and have an American Spinal Injury Association Impairment Scale classification of C or D.
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NervGen Advances NVG-291 Toward Potential Registration
The first participant dosed marks a significant milestone in NervGen’s effort to advance a pharmacological approach to neurological repair. Following a successful End-of-Phase 2 meeting, the company reported alignment with the FDA on RESTORE’s registrational design. The trial is intended to build on the clinical findings from CONNECT SCI while evaluating NVG-291 in a larger, controlled study focused on meaningful functional outcomes. NervGen is also advancing its next-generation candidate, NVG-300, for neurotraumatic and neurological conditions with significant unmet medical needs. With RESTORE underway, NervGen expects to complete enrollment in the second half of 2027 and report topline data in the first half of 2028, subject to the progress of the study.
Source::NervGen, press release
