NervGen Announces First Participant Dosed in RESTORE, a Phase 3 Registrational Study Evaluating NVG-291 in Chronic Spinal Cord Injury
Key Highlights
- ➤NervGen (NGEN) dosed the first participant in Phase 3 RESTORE.
- ➤RESTORE targets hand-function improvement in chronic cervical motor-incomplete spinal cord injury.
- ➤Enrollment completion anticipated in the second half of 2027.
- ➤Topline RESTORE data expected in the first half of 2028.
- ➤FDA aligned with RESTORE’s registrational design after an End-of-Phase 2 meeting.
Expert Statements
Adam Rogers, MD, Chief Executive Officer of NervGen
“Dosing the first participant in RESTORE marks a critical milestone for NervGen and a major step toward our goal of restoring function and independence for people living with spinal cord injury.”
Adam Rogers, MD, Chief Executive Officer of NervGen
“This progress reflects the expertise and unwavering dedication of our team in building on the compelling clinical results from CONNECT SCI to advance NVG-291 into a Phase 3 registrational study.”
Adam Rogers, MD, Chief Executive Officer of NervGen
“We believe NVG-291 has the potential to fundamentally change the outlook for recovery and open a new world of possibilities for people living with spinal cord injury.”
Adam Rogers, MD, Chief Executive Officer of NervGen
“Meaningful gains in function can help individuals rely less on caregivers and regain a greater sense of control and confidence in their everyday lives.”
Adam Rogers, MD, Chief Executive Officer of NervGen
“We are grateful to the participants, families and investigators for their trust and commitment.”
* RESTORE is evaluating NVG-291’s potential to improve hand function and quality of life in individuals living with chronic cervical motor-incomplete spinal cord injury * Study builds on functional improvements observed in the placebo-controlled Phase 1b/2a CONNECT SCI study, with FDA alignment on the Phase 3 registrational design * Enrollment completion anticipated in the second half of 2027; topline data expected in the first half of 2028 MIAMI, Oct. 12, 2026 (GLOBE NEWSWIRE) -- NervGen (NASDAQ: NGEN), a late-stage clinical biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today announced that the first participant has been dosed in RESTORE, a Phase 3 registrational study evaluating NVG-291 in individuals living with chronic cervical motor-incomplete SCI. NervGen anticipates completing enrollment in the second half of 2027 and reporting topline data in the first half of 2028.
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