EL7.AI
StocksMedium•12 November 2026•
4 min read

NervGen Begins Phase III Trial of NVG-291 After First Dose in Spinal Cord Injury Study

Key Facts

1RESTORE is targeting about 150 participants in the United States and Canada.
2GRASSP QtP improvement at Week 12 was about 3.7 points with NVG-291 versus 0.4 points with placebo, and did not reach statistical significance in the initial reading.
3NervGen expects to complete enrollment in the second half of 2027 and announce topline results in the first half of 2028.
4In CONNECT SCI follow-up, 75% of NVG-291 recipients versus 33% of the placebo group reported substantial or very substantial overall improvement.

NervGen said on October 12, 2026, that the first participant had been dosed in RESTORE, a pivotal Phase III study of NVG-291 in patients with chronic, motor-incomplete cervical spinal cord injuries. The start of dosing moves the program into advanced clinical testing, while an announcement that the U.S. Food and Drug Administration granted the drug breakthrough therapy designation on November 12, 2026, could not be verified. The company had said the study would test the drug’s effect on hand function, the primary endpoint agreed with the agency. The trial follows earlier results from CONNECT SCI, which did not establish statistical significance on the quantitative prehension measure at Week 12. RESTORE therefore remains the current focus for evaluating NVG-291’s efficacy and safety in this patient group.

RESTORE plans to enroll about 150 participants in the United States and Canada, according to NervGen’s announcement of the study’s launch. The trial is designed as randomized, double-blind and placebo-controlled, enabling a comparison of treatment outcomes between participants receiving NVG-291 and the control group. Participants receive daily subcutaneous injections for 12 weeks, followed by a four-week observation period. The primary outcome measures change in hand function using the GRASSP Quantitative Prehension measure. Secondary measures include independence and quality of life, according to the study design announced by the company.

NervGen set Week 12 for measuring the primary endpoint after an end-of-Phase II meeting with the FDA on April 7, 2026. The company said it reached agreement at that meeting on RESTORE’s criteria, including measuring the change from baseline in GRASSP Quantitative Prehension at Week 12. This means the new study focuses on testing hand function using a prespecified measure rather than relying solely on a general assessment of symptoms. The company links this measure to a design that also includes indicators of independence and quality of life. The program’s results are expected to be judged on the outcomes of this pivotal trial, according to the plan announced by the company.

Earlier CONNECT SCI data provide a numerical comparison for this measure: the actual change from baseline at Week 12 was about 3.7 points in the NVG-291 group versus 0.4 points in the placebo group. NervGen said, however, that the improvement trend in this initial reading did not reach statistical significance. The results thus showed a numerical difference between the groups without establishing a statistically significant advantage on the quantitative prehension measure in that analysis. This distinction matters when assessing claims of functional improvement, since the specified measure and the statistical result are separate elements. RESTORE will test the same measure as its primary endpoint, according to its announced design.

In expanded follow-up data from CONNECT SCI published in November 2025, 75% of participants who received NVG-291, or 6 of 8, said their overall symptoms had improved substantially or very substantially. The corresponding share in the placebo group was 33%, or 3 of 9 participants, according to NervGen. These percentages were based on interviews conducted after the study and differ from the quantitative GRASSP QtP measure, which did not reach statistical significance in the initial Week 12 reading. The figures represent two different types of outcomes: participants’ overall assessment of improvement and the recorded change on a hand-function measure. This follow-up provides additional context for the program, while the Phase III trial remains the next test under the design announced by the company.

The FDA says breakthrough therapy designation is intended to expedite the development and review of drugs for serious conditions when preliminary clinical evidence suggests they may produce substantial improvement over available therapies on a clinically significant endpoint. The designation does not, by itself, mean a drug has received marketing approval. The reported event in the November 12 announcement could not be verified through a reliable public source in the available information, and neither the granting of the designation nor the basis for the decision could be verified. The company announced in October 2023 that NVG-291 had received Fast Track designation for spinal cord injury, an earlier regulatory designation separate from breakthrough therapy. Clinical evaluation of the drug is now continuing through RESTORE, which has already begun dosing.

NervGen said in its study launch announcement that it expects to complete enrollment in the second half of 2027, with topline results in the first half of 2028. These are the timelines the company announced on October 12, 2026, while completion of recruitment and the initial readout remain steps that follow the start of dosing. RESTORE will combine hand-function measures with indicators of independence and quality of life in its published design. Results will be based on a comparison with placebo in a randomized, double-blind study. Until then, earlier CONNECT SCI data remain clinical context for the program, while RESTORE is the ongoing pivotal study of NVG-291.