NervGen Pharma, a clinical-stage biotechnology aimed at treatment solutions for nervous system damage, has partnered with Shirley Ryan AbilityLab of Northwestern University, to launch the company’s first trial with its lead compound, NVG -291. The single-site clinical trial (scheduled to start in the second half of 2022) is expected to be a placebo-controlled trial that evaluates the safety of NVG-291 in the treatment of acute or subacute (i.e. less three months after injury) and chronic patients (more than one year after injury).
According to NervGen, NVG-291 builds 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 regulated at the rise in response to nervous system damage and inhibit repair. The team designed NVG-291 for this inhibition by CSPGs, which are believed to enhance 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 have been following Silver’s work in the field for some time.
“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 neural pathways as well as behavioral outcomes,“noted Perez.”The ability of NVG-291 to demonstrate significant recovery of 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 a member of the NervGen Spinal Cord Injury Clinical Advisory Committee, said the partnership around NCG-291 centers on “a very unique trial design. and intriguing.
“Rationale for including both acute and chronic patients in a study highlights the large potential of the NVG-291 mechanism in SCI», Noted the guest. “The use of Shirley Ryan’s AbilityLab in a single-center study that implements advanced electrophysiological techniques to monitor connectivity at the injury site will allow for reproducible testing to explore the effects of NVG-291 on motor recovery, possibly shaping the impact of subsequent studies. “
Paul Brennan, President and CEO of NervGen, said the preclinical results around NVG-291 provide patients with spinal cord injury “a real reason to hope. “
“With these patients in mind, the NervGen team has worked diligently since its inception to advance this technology in 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 look forward to completing this study in the first half of 2022.. “
Brennan added that NervGen also plans to exploit the mechanism of action shown in NVG-291 to continue studies examining its viability in the treatment of Alzheimer’s disease and multiple sclerosis.
NervGen is currently conducting a Phase I trial in healthy volunteers. Following the completion of ongoing toxicology studies commissioned by the U.S. Food and Drug Administration and the provision of available data to the agency, NervGen plans to seek the removal of the partial study suspension to assess safety and pharmacokinetics.