VANCOUVER, British Columbia--(BUSINESS WIRE)--NervGen Pharma Corp., (TSX-V: NGEN) (OTCQX: NGENF) (“NervGen” or the “Company”), 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.
About NervGen
NervGen is restoring life’s potential by creating innovative treatments of nervous system damage due to injury or disease. The Company is initially developing treatments for multiple sclerosis, spinal cord injury and Alzheimer’s disease. For more information, go to www.nervgen.com.
About Shirley Ryan AbilityLab
Shirley Ryan AbilityLab, formerly the Rehabilitation Institute of Chicago, is a global leader in physical medicine and rehabilitation for adults and children with the most severe, complex conditions ranging from traumatic brain and spinal cord injury to stroke, amputation, and cancer-related impairment. The organization expands and accelerates leadership in the field that began at the Rehabilitation Institute of Chicago in 1953. The quality of its care and research has led to the designation of the “No. 1 Rehabilitation Hospital in America” by U.S. News & World Report every year since 1991. Upon opening in March 2017, the $550 million, 1.2 million square foot Shirley Ryan AbilityLab became the first-ever translational research hospital in which clinicians, scientists, innovators, and technologists work together in the same space, surrounding patients, discovering new approaches and applying (or “translating”) research in real time. This unique model enables patients to have 24/7 access to the brightest minds, the latest research, and the best opportunity for recovery. For more information, go to www.sralab.org.
About NVG-291
NervGen holds the exclusive worldwide rights to NVG-291 and is developing a unique new class of drugs around the technology. NVG-291 is a therapeutic peptide which is a mimetic of the intracellular domain of protein tyrosine phosphatase (PTPσ), a cell surface receptor known to interact with chondroitin sulfate proteoglycans (CSPGs) and to be involved in the regulation of neuroplasticity and central nervous system repair. In preclinical studies, NVG-291 has demonstrated the potential to promote repair mechanisms in the nervous system, including axonal regeneration, remyelination, and enhanced plasticity. The demonstration of repair via these mechanisms in animal models of nervous system injury has been accompanied by recovery of multiple neurological functions, including motor, sensory, autonomic and cognitive functions. NVG-291 has shown efficacy in a range of animal models, including models of nervous system trauma (e.g. spinal cord injury, peripheral nerve injury) and disease (multiple sclerosis, stroke).
About Spinal Cord Injury
Spinal cord injury is a devastating condition in which axons and neurons in the spinal cord are injured or transected. As a result, the messages to and from the brain cannot get through the injury to enable movement, perception of sensation, or control of the autonomic nervous system (for example, bladder control). Symptoms will depend on injury location and severity and may include paralysis, breathing difficulty, loss of sensation, bowel, bladder, and sexual function. Currently, in the US there are no approved pharmaceutical treatments for spinal cord injury, either to contain the injury, or in the long term to help the patient recover from injury.
The most recent estimate of the annual incidence of spinal cord injury is approximately 54 cases per one million people in the US, which equals approximately 17,900 new spinal cord injury cases each year. The estimated number of people with spinal cord injury living in the US is approximately 296,000 persons, with a range from 252,000 to 373,000 persons.
In the US, average yearly expenses in the first year following injury range from over $1 million for the most severely injured patients to $380,000 for less severe injuries. Lifetime costs for a 25-year-old range from approximately $1.7 million to over $5 million.
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Cautionary Note Regarding Forward-Looking Statements
This news release may contain “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian and United States securities legislation. Such forward-looking statements and information herein include, but are not limited to, the Company’s current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words “may”, “will”, “would”, “should”, “could”, “expect”, “plan”, “intend”, “trend”, “indication”, “anticipate”, “believe”, “estimate”, “predict”, “likely” or “potential”, or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the timing, objectives and study design of the clinical development of NVG-291, including the planned single site Phase 1b/2a clinical trial in SCI exclusively with Shirley Ryan AbilityLab and the ongoing Phase 1 study in healthy volunteers; our belief that NVG-291 could redefine the treatment of SCI if preclinical results translate to patients; the potential for the planned Phase 1b/2a study in SCI to shape the impact of subsequent studies; our goal of bringing NVG-291 to patients as quickly as possible; the favorable tolerability and pharmacokinetic profile of NVG-291; the Phase 1 results reported to date; our confidence that the efficacy achieved in multiple preclinical disease and injury models will translate into positive results in our upcoming clinical trials with patients; the timing and requirements to remove the partial clinical hold initiated by the FDA; the clinical development of NVG-291 for Alzheimer’s disease, multiple sclerosis and spinal cord injury; the belief that inhibiting the activity of PTPσ is a promising target for reducing the clinical effects of nervous system damage through multiple mechanisms; the estimates of the incidence and prevalence of SCI in the US and the annual and lifetime costs of care for SCI patients; and the creation of innovative treatments of nervous system damage due to injury or disease.
Forward-looking statements are based on estimates and assumptions made by the Company in light of management’s experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable in the circumstances. In making forward-looking statements, the Company has relied on various assumptions, including, but not limited to: the Company’s ability to manage the effects of the COVID-19 pandemic; the accuracy of the Company’s financial projections; the Company obtaining positive results in its clinical and other trials; the Company obtaining necessary regulatory approvals; and general business, market and economic conditions.
Many factors could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, a lack of revenue, insufficient funding, the impact of the COVID-19 pandemic, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the “Risk Factors” section of the Company’s Annual Information Form, Prospectus Supplement, financial statements and Management Discussion and Analysis which can be found on SEDAR.com. All clinical development plans are subject to additional funding.
Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and we have no intention and undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement.
