ANCOUVER, British Columbia–NervGen Pharma Corp., (TSX-V: NGEN) (OTCQX: NGENF), a clinical stage biotech company dedicated to creating innovative treatments for nervous system damage, is pleased to announce it has entered into a Memorandum of Understanding with Shirley Ryan AbilityLab with the intention of performing NervGen’s first clinical trial with the Company’s proprietary NVG-291 in spinal cord injury (SCI) patients. The single site clinical trial, which is expected to start in the second half of 2022, will be a placebo-controlled trial, assessing the safety and efficacy of NVG-291 in treating acute/subacute (<3 months post-injury) and chronic (≥1 year post-injury) patients. In two independent animal studies published in Nature and Experimental Neurology, NVG-291 treatment resulted in significant recovery in mobility and/or bladder function, despite experiencing a debilitating spinal cord injury.
NVG-291 is based on the groundbreaking discovery by Dr. Jerry Silver at Case Western Reserve University of a class of molecules (chondroitin sulfate proteoglycans, or CSPGs) that are upregulated in response to nervous system damage and that inhibit repair. NVG-291 was designed to bypass this inhibition by CSPGs, thereby enhancing the body’s natural repair mechanisms, including plasticity, regeneration and remyelination.
“We have been following Dr. Silver’s work for years and are very excited to be the first center working with NervGen on this important spinal cord injury study,” stated Monica A. Perez, PT, PhD, Scientific Chair of the Arms + Hands Lab at Shirley Ryan AbilityLab; Professor of Physical Medicine & Rehabilitation at Northwestern University; and Research Scientist at the Edward Hines Jr. VA Hospital. “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. 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.”
“NervGen and Shirley Ryan AbilityLab are planning a very unique and intriguing trial design, into which I have been fortunate to provide input,” stated James Guest, MD, PhD, FACS, Professor of Neurological Surgery at the University of Miami and member of NervGen’s Spinal Cord Injury Clinical Advisory Board. “The rationale to include acute and chronic patients in a study underscores the broad potential of the mechanism of NVG-291 in SCI. 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. Partnering with Shirley Ryan AbilityLab, a leading institution in spinal cord injury research and management of patients with spinal cord injury, is an exceptional opportunity for NervGen.”
“NervGen is excited to be working towards executing this important clinical trial for spinal cord injury patients,” stated Paul Brennan, NervGen’s President & CEO. “The unprecedented preclinical results utilizing NVG-291 that were published by Dr. Silver and others gave the spinal cord injury community 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. Our recent interim data from the single ascending dose (SAD) portion of our Phase 1 clinical study was very encouraging and we’re looking forward to completing this study in the first half of 2022. In addition to initiating this important clinical trial in spinal cord injury, the Company plans to leverage the same powerful mechanism of action demonstrated by NVG-291 to conduct studies by the end of 2022 for the treatment of both Alzheimer’s disease and multiple sclerosis patients.”
NervGen is currently conducting a Phase 1 clinical trial in healthy volunteers and recently reported on the results of the SAD portion of the study. The Company has received safety review committee and ethics committee approval to proceed to the multiple ascending dose (MAD) portion of the study where subjects will be dosed in a blinded fashion with NVG-291 or placebo once a day for 14 consecutive days. Following completion of ongoing toxicology studies requested by the United States Food and Drug Administration (FDA), and provision of available data from the ongoing Phase 1 study to the FDA, NervGen will seek removal of the partial clinical trial hold initiated by the FDA and evaluate the safety and pharmacokinetics of NVG-291 in cohorts of healthy males and healthy premenopausal females, separate from the SCI study announced in this press release. Following completion of the Phase 1 study in healthy males and the premonopausal females, NervGen intends to proceed to the planned Phase 1b/2 safety and efficacy studies in spinal cord injury, multiple sclerosis, and Alzheimer’s disease patients.
