A Vancouver biotech that is in early clinical trials with a drug candidate that may repair damaged nerves in spinal cord injuries has received Food and Drug Administration (FDA) Fast Track designation.
The designation expedites the review of new drugs for treating serious or life-threatening diseases.
NervGen Pharma Corp. (TSX-V:NGEN, OTCQX:NGENF) recently began Phase 1b/2a of its drug candidate, NVG-291. The company says testing in rodents has been found to promote nervous system repair and “functional recovery” in spinal cord injury, peripheral nerve injury, multiple sclerosis and stroke.
“The FDA’s decision to grant Fast Track designation for NVG-291 underscores the significance and severity of the unmet medical need that exists for individuals living with spinal cord injury and their caregivers,” NervGen CEO Mike Kelly said in a news release.
“We believe that NVG-291 has the potential to be the first approved treatment indicated to enable neurological/functional recovery following spinal cord injury, and we look forward to working closely with the FDA in the clinical development process with the goal of obtaining approval to market NVG-291 as soon as possible.”
Last year, NervGen raised $21 million in a private placement, and last month the company announced the first candidate had been dosed in Phase 1b/2a of clinical trials.
Last week, the company announced that John Ruffolo, founder and managing partner of the Canadian venture capital firm Maverix Private Equity, and founder of OMERS Ventures, had been appointed to NervGen’s board of directors.
Ruffolo has a personal interest in the treatment of spinal cord injuries, as he was left paralyzed from the waist down in after being struck, while cycling, by a truck in Toronto in 2020, according to CBC.
“I have been closely following NervGen and its very important drug, NVG-291, for some time and am excited that it is now being administered to individuals with spinal cord injury in this important clinical trial,” Ruffolo said in a NervGen news release.
“As someone who experiences daily the life-altering impact of a spinal cord injury, it is thrilling to finally see NVG-291 in the clinic with the potential to demonstrate nervous system repair. I look forward to doing my part to drive NervGen forward and to help realize the potential of this important technology.”
(This story has been updated to correct incorrect spellings.)