Most spinal cord injuries happen in an instant, but the impact—including loss of muscle control, pain, breathing difficulties and depression—can last a lifetime. And no approved treatments can regenerate nerves after the injury or improve on lifelong consequences.
That could change. In a recent clinical trial, a drug known as NVG-291, which was developed at Case Western Reserve University School of Medicine, has helped people who suffered a spinal cord injury improve hand function, bladder control and other functions. The drug works by circumventing biological processes that prevent injured nerves from re-growing after trauma to the central nervous system. Study participants reported, for example, being better able to get dressed in the morning, hold eating utensils, and use a computer mouse and keyboard.
“These are important and impactful real-world improvements,” said Adam Rogers, MD, CEO of NervGen Pharma, a Vancouver-based biotech company that licensed the NVG-291 technology from CWRU in 2018 and began clinical trials three years later.
NVG-291 was developed in the lab of renowned neuroscientist and professor Jerry Silver, PhD (GRS ’74, anatomy), who died in January 2025. Silver spent his career studying why neurons in the central nervous system do not regenerate after injury, then used that understanding to point the way to therapeutics, said Brad Lang, PhD (GRS ’15, neurosciences).
For Lang, who built on Silver’s longtime work and led the discovery of NVG-291 as a doctoral student in Silver’s lab, the news from NervGen was gratifying. “Seeing a discovery reach patients is the dream of every scientist,” said Lang, now CEO of Auni Therapeutics, a biotech startup he launched in August.
Spinal cord nerves carry electrical impulses from the brain to the body and back again. When those nerves are injured, the electrical signals traveling along them are interrupted, resulting in loss of sensation and muscle control. Investigating why the injured nerves don’t heal naturally, Silver had previously discovered that the scar that forms after a spinal cord injury contains molecules called chondroitin sulfate proteoglycans (CSPGs) that inhibit nerve re-growth. NVG-291 allows injured nerves to slip past the CSPGs so that they can re-grow and reconnect.
In November, NervGen reported results from an expanded Chicago-based clinical trial, which involved 20 paralyzed participants who had experienced cervical spinal cord injury one to 10 years earlier. They had volunteered to receive daily injections of either NVG-291 or a placebo and also do daily exercises for 12 weeks. Researchers found that subjects who received NVG-291 had improved hand function, fewer uncontrollable muscle contractions and better bladder control than those who received the placebo. Interviews conducted during the year following the study confirmed continued and wide-ranging upper and lower body improvements as well as gains in many daily activities.
Conditions such as Alzheimer’s, multiple sclerosis and ALS were once considered irreversible. CWRU researchers and their partners are challenging that notion through groundbreaking work.
The next clinical trial, which will involve more participants at up to 60 sites in the United States and Canada, is expected to begin before fall.
“This company is built on the back of Jerry Silver's pioneering work in neurotrauma and neurodegenerative diseases,” Rogers said. “His legacy is intertwined with this company.”
