- The dose of NVG-291 in the first cohort is already above the highest corresponding dose that resulted in dramatic functional improvements in animal models
- Approval moves NervGen one step closer to Phase 1b/2 efficacy studies in Alzheimer’s disease, multiple sclerosis and spinal cord injury patients later in 2022
- NervGen’s proprietary NVG-291, has been demonstrated in preclinical studies to promote repair mechanisms in the nervous system, including axonal regeneration, remyelination and plasticity
Vancouver, Canada. March 15, 2022 – NervGen Pharma Corp. (TSX-V: NGEN; OTCQX: NGENF) (“NervGen” or the “Company”), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, has received approval from the Safety Review Committee to advance to the second cohort in the multiple ascending dose (MAD) portion of its Phase 1 clinical trial of the Company’s proprietary lead compound, NVG-291. In preclinical studies, NVG-291 has been demonstrated to promote repair mechanisms in the nervous system, including axonal regeneration, remyelination and enhanced plasticity.
Paul Brennan, NervGen’s President & CEO, stated, “Advancing to the second cohort in the MAD portion of our Phase 1 clinical trial is a significant milestone for the Company. The dose of NVG-291 administered in the first cohort is already above the highest corresponding dose found to be efficacious in animal models and is substantially higher than the lower effective doses where dramatic functional improvements were observed. While we will proceed to evaluate higher doses in the remaining MAD cohorts of the Phase 1 study, the blinded safety data observed so far are encouraging and highlight that we are a step closer to initiating the Phase 1b/2 efficacy studies in Alzheimer’s disease, multiple sclerosis and spinal cord injury patients later in 2022.”
Dr. Daniel Mikol, NervGen’s Chief Medical Officer, noted, “We are extremely pleased with the progress of the Phase 1 study. In the first MAD cohort, subjects completed 14 days of blinded treatment with NVG-291 or placebo, administered by daily subcutaneous injection. Subjects were evaluated throughout the treatment phase and one week after the final dose of study drug. Based on a thorough safety evaluation, including a blinded review of adverse events, vital signs and laboratory data, the Safety Review Committee determined it was appropriate to advance to the next MAD cohort. Moreover, it is very encouraging that the day 1 and day 14 pharmacokinetic characteristics for NVG-291 at the tested dose level were very similar to those observed at the same dose level in the single ascending dose portion of the Phase 1 study. A reproducible pharmacokinetic profile is a highly desirable property for any drug being developed for human use.”
Following completion of the MAD portion of the study and ongoing toxicology studies requested by the United States Food and Drug Administration (FDA), NervGen will seek removal of the partial clinical trial hold initiated by the FDA and evaluate bridging cohorts of healthy males and in healthy premenopausal females.
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 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 such as spinal cord injury and peripheral nerve injury, and diseases such as multiple sclerosis and stroke.
NervGen is restoring life’s potential by creating innovative treatments for nervous system damage due to injury or disease. The Company is initially developing treatments for Alzheimer’s disease, multiple sclerosis and spinal cord injury. For more information, go to www.nervgen.com.
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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 of the clinical development of NVG-291; the objectives, timing and study design of the Phase 1 study in healthy volunteers; our confidence that we can translate the unprecedented outcomes in animal studies to humans in our upcoming clinical trials; the timing and requirements to proceed to higher dose cohorts in the MAD portion of the Phase 1 clinical trial and to remove the partial clinical hold initiated by the FDA; our belief that the blinded safety data observed so far are encouraging and highlight that we are a step closer to initiating the Phase 1b/2 efficacy studies; our belief that the similarities in the pharmacokinetic characteristics for NVG-291 in the MAD and single ascending dose portions of Phase 1 is indicative of a highly desirable property for any drug being developed for human use; our clinical trial designs and timing to evaluate the therapeutic potential of NVG-291 in patients in Phase 1b/2 clinical trials in Alzheimer’s disease, multiple sclerosis and spinal cord injury upon successful completion of the Phase 1 trial and bridging studies; the belief that modulating the activity of PTPσ is a promising target for reducing the clinical effects of nervous system damage through multiple mechanisms; and the creation of innovative treatments of nervous system damage due to trauma 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.
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