NervGen’s Peptide reserved for the FDA’s regulatory final

Announcement

NervGen’s robust investigational peptide therapeutic, NVG-291, has successfully enhanced the quality of life and improved functional performance in a patient group having chronic spinal cord injury. The drug for the same has been scheduled for late-stage development. NervGen confirmed that it will reserve a slot with the FDA early next year to discuss a regulatory path ahead for NVG-291 in chronic spinal cord injury and for the end-of-Phase 2 deliberations.

The CEO, Adam Rogers, said, “Observing the clinical results at the time of the CONNECT SCI Study, the NVG-291 showcased its first therapy, elaborating the potential to allow the nervous system to repair itself without any dependency.”

NervGen’s studies timeline

In the 16^th week follow-up of the Phase 2 CONNECT SCI study, patients receiving the treatment with NVG-291 experienced a 2.6-fold increase in the level of improvement and effectiveness in the graded, redefined examination of sensibility, prehension, and strength inventory. This refers to the tools used to calculate a patient group’s clinical function and impairment. The peptide also showed its potential value by improving the quality of life and hand function.

While in conversation the 75% of treated patients said that they felt a much better improvement overall in the symptoms of their spinal cord injury (SCI). In comparison, it was better than that of 33% among placebo counterparts. Apart from these patients, 67% of participants in the NVG-291 round experienced excellent bladder control, and 56% faced lower muscle spasticity.

One of the patients gave a positive response to the NVG-291 treatment, claiming that he could now take care of himself by doing his daily chores and routine all by himself, like brushing teeth, doing his hair and also eating food on his own. The patient felt happy to get on the art projects, a task that was nearly impossible before NVG-291 treatment.

With the end of the Phase 2 meeting, the company is planning to start the pivotal Phase 3 study in chronic SCI, expecting the enrolment to start in mid-2026. In September, the NervGen terminated the Type C meeting with the FDA at a time when the regulatory agency stated that there a various regulatory pathways open for NVG-291.

Considering this, the NervGen will be scheduling the meeting with the FDA regulatory to open the registration path track for the drug and continue serving the excellent drug at the commercial stage.