NervGen, a late-stage clinical biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, has dosed the first participant in a phase 3 registrational study evaluating NVG-291 in individuals living with chronic cervical motor-incomplete SCI. NervGen anticipates completing enrolment in the second half of 2027 and reporting topline data in the first half of 2028.
NervGen achieved alignment with the US Food and Drug Administration (FDA) on the study’s registrational design following its successful end-of-phase 2 meeting. The phase 3 study builds directly on findings from the placebo-controlled phase 1b/2a study, which informed the selection of primary and secondary endpoints, treatment duration and participant-reported measures, with a focus on evaluating functional recovery and its impact on independence and quality of life.
Restore is a multicentre, randomised, double-blind, placebo-controlled phase 3 registrational study evaluating the efficacy and safety of NVG-291 in adults living with chronic cervical motor-incomplete SCI. The study is expected to enrol approximately 150 participants across the United States and Canada.
The study’s primary endpoint assesses improvement in hand function, a leading recovery priority for individuals with cervical SCI, as measured by GRASSP Quantitative Prehension. Secondary endpoints and blinded participant interviews will provide additional insight into functional independence and quality of life.
Eligible participants are one to 10 years following a traumatic SCI, have a motor level at C7 or higher on both sides and have an American Spinal Injury Association (ASIA) impairment scale classification of C or D. Participants will be randomised 1:1 to receive NVG-291 or placebo by once-daily subcutaneous injection for 12 weeks, followed by a four-week observation period. An optional 12-week open-label extension is planned following study completion.
