NervGen Announces First Participant Dosed in RESTORE, a Phase 3 Registrational Study Evaluating NVG-291 in Chronic Spinal Cord Injury
FDA alignment on the registrational design follows the earlier placebo-controlled CONNECT SCI study.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
NervGen (NGEN) has dosed the first participant in RESTORE, its Phase 3 registrational study of NVG-291 for chronic spinal cord injury. The study evaluates potential improvements in hand function and quality of life in people with chronic cervical motor-incomplete spinal cord injury, involving the neck region with some motor function preserved.
NervGen anticipates enrollment completion in the second half of 2027 and topline data in the first half of 2028. The company achieved FDA alignment on RESTORE’s registrational design following its End-of-Phase 2 meeting. RESTORE builds on functional improvements observed in the placebo-controlled Phase 1b/2a CONNECT SCI study. Those findings informed primary and secondary endpoint selection, treatment duration and participant-reported measures, with a focus on functional recovery and its impact on independence and quality of life.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointFirst participant dosed advances NVG-291 into the Phase 3 RESTORE registrational study.
- Moderate pointFDA alignment achieved on RESTORE’s registrational design following the End-of-Phase 2 meeting.
- Minor pointFunctional improvements observed in placebo-controlled Phase 1b/2a CONNECT SCI informed RESTORE’s design.
- Minor point. Forward-looking: it has not happened yet and may not happen.Enrollment completion anticipated in the second half of 2027; topline data expected in the first half of 2028.
Negative
- None.
Key Figures
- Participant dosed
- 1 participant
- First participant dosed in RESTORE
- Enrollment completion
- Second half of 2027
- Anticipated for RESTORE
- Topline data
- First half of 2028
- Expected from RESTORE
Previous Clinical trial Reports
-
FDA alignment established RESTORE's Phase 3 design and incorporated findings from CONNECT SCI.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 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.
“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,” said 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. 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. Meaningful gains in function can help individuals rely less on caregivers and regain a greater sense of control and confidence in their everyday lives. We are grateful to the participants, families and investigators for their trust and commitment.”
NervGen achieved alignment with the U.S. Food and Drug Administration (FDA) on RESTORE’s registrational design following its successful End-of-Phase 2 meeting. The Phase 3 RESTORE study builds directly on findings from the placebo-controlled Phase 1b/2a CONNECT SCI 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.
About the Phase 3 RESTORE Study
RESTORE is a multicenter, randomized, 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 enroll 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 ten 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 randomized 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. For additional information, including eligibility criteria and study locations, visit ClinicalTrials.gov (identifier: NCT07799532).
About NervGen
NervGen (NASDAQ: NGEN) is a late-stage clinical biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions. The Company’s mission is to transform the lives of individuals living with SCI by enabling the nervous system to repair itself. NervGen’s lead therapeutic candidate, NVG-291, is a subcutaneously administered neuroreparative peptide designed to target the inhibitory CSPG-PTPσ pathway. NVG-291 is the first pharmacologic candidate to improve function, independence, and quality of life in chronic SCI, as observed in the Phase 1b/2a CONNECT SCI study. NVG-291 has received Fast Track designation from the FDA and Orphan Drug designation from the European Medicines Agency for the treatment of SCI. Through NVG-291 and its next-generation candidate, NVG-300, NervGen is pursuing a pharmacologic approach to transform the treatment paradigm for neurotraumatic and neurologic conditions with significant unmet medical need. For more information, visit www.nervgen.com and follow NervGen on X and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This news release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable securities laws (collectively, “forward-looking statements”). Statements regarding the Company’s current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, and other future events or developments constitute forward-looking statements. The words “may”, “will”, “would”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “likely” or “potential”, or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the design, conduct and anticipated timelines of the RESTORE study; the development and potential therapeutic benefits of the Company’s product candidates; and other factors described in the “Risk Factors” section of the Company’s most recently filed Annual Information Form and Annual Report on Form 40-F, its management’s discussion and analysis for the year ended December 31, 2025, and subsequent filings with Canadian securities regulators and the U.S. Securities and Exchange Commission. These documents are available under the Company’s profile on SEDAR+ at www.sedarplus.ca and on the SEC’s website at www.sec.gov. Readers should not place undue reliance on forward-looking statements made in this news release. Unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement.
Contacts
On365 Partners, Investor Relations
ir@nervgen.com
203.293.8091
David Schull or Ignacio Guerrero-Ros, Ph.D., Media
David.Schull@russopartnersllc.com
Ignacio.Guerrero-Ros@russopartnersllc.com
858.717.2310
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is NervGen’s Phase 3 RESTORE study evaluating?
RESTORE evaluates NVG-291’s potential to improve hand function and quality of life in people with chronic cervical motor-incomplete spinal cord injury. The first participant has been dosed in the registrational study.
When does NervGen expect RESTORE enrollment completion and topline results?
NervGen anticipates completing enrollment in the second half of 2027 and reporting topline data in the first half of 2028.