NervGen Pharma, a clinical-stage biotech aimed at solutions treating nervous system damage—has forged a partnership with Northwestern University’s Shirley Ryan AbilityLab, with the goal of launching the company’s first trial with its lead compound, NVG-291. The single-site clinical trial (anticipated to kick off in the second half of 2022) is set to be a placebo-controlled trial that assesses the safety of NVG-291 in treating acute or subacute (i.e. less than three months post-injury) and chronic (more than a year after injury) patients.
According to NervGen, NVG-291 is built on the work of Jerry Silver, a researcher at Case Western Reserve University, around the discovery of a class of molecules (chondroitin sulfate proteoglycans, or CSPGs) that are upregulated in response to nervous system damage and that inhibit repair. The team designed NVG-291 to by this inhibition by CSPGs, which reportedly bolsters the human body’s natural repair mechanisms (such as plasticity, regeneration, and remyelination.
Monica Perez, scientific chair of the Arms + Hands Lab at Shirley Ryan AbilityLab, said her team has been following Silver’s work in the area for a while.
“One of the important aspects of this single-center, placebo-controlled trial is the use of advanced electrophysiology to assess transmission in cortical and subcortical neuronal pathways as well as behavioral outcomes,” Perez noted. “The ability of NVG-291 to demonstrate meaningful recovery in motor function, sensory function, and bladder control in animal models is exceptional. If these results translate to patients, NVG-291 could redefine the treatment of spinal cord injury.”
James Guest, professor of neurological surgery at the University of Miami and member of NervGen’s Spinal Cord Injury Clinical Advisory Board, said the partnership around NCG-291 centers around “a very unique and intriguing trial design.
“The rationale to include acute and chronic patients in a study underscores the broad potential of the mechanism of NVG-291 in SCI,” Guest noted. “Using Shirley Ryan AbilityLab in a single-center study that implements advanced electrophysiological techniques to monitor connectivity across the site of injury will allow reproducible testing to explore NVG-291’s effects on motor recovery, possibly shaping the impact of subsequent studies.”
Paul Brennan, NervGen’s president and CEO, said the preclinical results around NVG-291 offer spinal-cord injury patients “a real reason for hope.”
“With these patients in mind, NervGen’s team has worked diligently since its inception to advance this technology into the clinic with the goal of bringing NVG-291 to patients as quickly as possible,” Brennan commented. “Our recent interim data from the single ascending dose (SAD) portion of our Phase I clinical study was very encouraging and we’re looking forward to completing this study in the first half of 2022.”
Brennan added that NervGen also plans to harness the mechanism of action shown in NVG-291 to pursue studies examining its viability in treating Alzheimer’s disease and multiple sclerosis.
NervGen currently is conducting a Phase I trial in healthy volunteers. Following completion of ongoing toxicology studies ordered by the US Food and Drug Administration and providing available data to the agency, NervGen plans to seek removal of the partial study hold to evaluate safety and pharmacokinetics.