NervGen's NVG-291 Shows Promise in Phase II Spinal Cord Injury Study

NervGen Pharma Corp. has announced positive results from its Phase II CONNECT SCI study, evaluating the investigational peptide therapeutic NVG-291 in patients with chronic spinal cord injury (SCI). The drug demonstrated significant improvements in functional performance and quality of life, positioning it for potential late-stage development.

Impressive Clinical Outcomes

The 16-week follow-up data revealed that patients treated with NVG-291 experienced a 2.6-fold greater mean improvement in the Graded Redefined Assessment of Strength, Sensibility and Prehension inventory compared to placebo. This assessment tool is crucial for measuring clinical impairment and function in SCI patients.

Additionally, NVG-291 showed notable enhancements in hand function and overall quality of life. Exit interviews provided compelling evidence of the drug's impact:

• 75% of treated patients reported "much" or "very much" improved overall symptoms of their SCI, compared to 33% in the placebo group.
• 67% of participants in the NVG-291 arm noted better bladder control.
• 56% of treated patients experienced lower muscle spasticity.

One patient's testimony highlighted the transformative effects of the treatment, stating, "I can now take care of myself," referring to newfound abilities such as personal grooming and engaging in art projects—tasks that were "impossible" before NVG-291 treatment.

Regulatory Pathway and Mechanism of Action

NervGen is making strides in advancing NVG-291 through the regulatory process. The company recently concluded a Type C meeting with the FDA, during which the regulator confirmed multiple potential regulatory pathways for the drug. A follow-up meeting is scheduled for early next year to further align on the registration path for NVG-291.

The peptide's mechanism of action is multifaceted, designed to repair the nervous system by:

• Promoting the formation of new neural connections
• Stimulating neuronal growth and remyelination
• Fostering a non-inflammatory environment in the brain

This comprehensive approach to nervous system repair is believed to be the key driver behind the observed functional improvements in patients.

NVG-291, administered via subcutaneous injection, received Fast Track designation from the FDA in October 2023, potentially expediting its development and review process.

As the pharmaceutical industry continues to seek breakthrough treatments for challenging neurological conditions, NervGen's progress with NVG-291 represents a significant step forward in addressing the unmet needs of chronic spinal cord injury patients.