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NervGen Doses First Patient in Phase 3 RESTORE Spinal Cord Injury Trial

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NGEN$1.73 −1.14%

NervGen Pharma Corp. (NGEN) has dosed the first subject in its pivotal Phase 3 RESTORE clinical study. The trial is evaluating the company's investigational drug, NVG-291, in individuals with chronic cervical motor-incomplete spinal cord injury.

The registrational study marks a key late-stage milestone, progressing the treatment program beyond earlier Phase 1b and Phase 2a research. The study aims to recruit approximately 150 participants across clinical sites in the United States and Canada, measuring hand function as its primary end point. NVG-291 has also received Fast Track status from the U.S. Food and Drug Administration, which can help facilitate a more streamlined review path if results are successful.

Management expects patient enrollment for the RESTORE trial to finish in the second half of 2027, with preliminary topline results anticipated in the first half of 2028. Shares of NervGen Pharma Corp. traded at $1.73, down 1.14% for the day.

Key points

  • NervGen Pharma dosed the initial patient in its Phase 3 RESTORE trial testing NVG-291 for chronic cervical motor-incomplete spinal cord injury.
  • The registrational study plans to enroll about 150 participants across clinical sites in the United States and Canada.
  • Hand function serves as the primary clinical endpoint evaluated in the study.
  • The treatment carries FDA Fast Track designation to support expedited developmental interactions and review.
  • Participant enrollment is scheduled to complete in late 2027, with initial topline data expected in early 2028.

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Questions and answers

What is the main goal of NervGen's Phase 3 RESTORE trial?

The Phase 3 RESTORE trial is evaluating NVG-291 in approximately 150 participants with chronic cervical motor-incomplete spinal cord injury, focusing on hand function as the primary clinical endpoint.

When will NervGen report topline data from the Phase 3 study?

NervGen expects to finish trial enrollment in the second half of 2027 and report preliminary topline results in the first half of 2028.

Does NVG-291 have any regulatory designations from the FDA?

Yes, NVG-291 has received Fast Track designation from the U.S. Food and Drug Administration, which may help expedite the regulatory process and review if trial results are positive.