NervGen will meet with the FDA early next year to align on a regulatory path forward for NVG-291 in chronic spinal cord injury.
NervGen’s investigational peptide therapeutic NVG-291 significantly improved functional performance and quality of life in patients with chronic spinal cord injury, positioning the drug for late-stage development.
The Canadian company will meet with the FDA early next year for end-of-Phase II deliberations and to align on NVG-291’s path forward, the biotech announced in a news release on Monday.
“Based on the clinical results observed in the CONNECT SCI Study, NVG-291 represents the first therapy demonstrating the ability to enable the nervous system to repair itself,” CEO Adam Rogers told BioSpace in an email on Monday.
At the 16-week follow-up in the Phase II CONNECT SCI study, patients treated with NVG-291 saw a 2.6-fold greater mean improvement in the Graded Redefined Assessment of Strength, Sensibility and Prehension inventory, a tool used to measure patients’ clinical impairment and function. The peptide also improved hand function and quality of life.
In exit interviews, 75% of treated patients said they experienced “much” or “very much” improved overall symptoms of their spinal cord injury (SCI), as compared with 33% among placebo counterparts. Additionally, 67% of participants in the NVG-291 arm noted better bladder control, while 56% encountered lower muscle spasticity.
“I can now take care of myself,” one patient said during the interview, according to NervGen, which paraphrased the answers for brevity. The patient was referring to the ability to “brush my hair, brush my teeth, cut my own food,” adding that, “I’ve even started working on art projects”—tasks that were “impossible” before NVG-291 treatment.
Following the end of the Phase II meeting, NervGen plans to initiate a pivotal Phase III study in chronic SCI, with enrollment expected to begin mid-2026, Rogers said.
NervGen in September concluded a Type C meeting with the FDA, during which the regulator confirmed that there are “multiple regulatory pathways” available for NVG-291. The biotech will meet with the FDA again early next year to “further align” with the regulator on a registration path for the drug.
“Based on the traditional regulatory pathway, our current guidance is to report topline Phase III data in the first half of 2028, followed by a regulatory submission soon thereafter,” Rogers added.
Designed to be delivered via a subcutaneous injection, NVG-291 is a therapeutic peptide that works by promoting the formation of new neural connections, the growth of neurons and their remyelination, as well as fostering a non-inflammatory environment in the brain. Through this mechanism of action, NVG-291 repairs the nervous system, leading to functional improvements, NervGen claims.
The drug was granted the FDA’s fast track designation in October 2023.
Editor’s Note (Nov 24): This story has been updated to include quotes from NervGen CEO Adam Rogers.
