- Human subjects now being enrolled in the second cohort of multiple ascending dose portion of the study
- NVG-291 dose 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
Vancouver, Canada. March 31, 2022 – NervGen Pharma Corp. (TSX-V: NGEN; OTCQX: NGENF) (“NervGen” or the “Company”), a clinical stage biotech company dedicated to developing a first-in-class neuroreparative drug to treat nervous system damage, will provide an update on its Phase 1 program with NVG-291 in healthy volunteers at the 2022 American Academy of Neurology Annual Meeting. NervGen’s Chief Medical Officer, Dr. Daniel Mikol, will present unblinded data from the single ascending dose (SAD) cohort of the study, and interim blinded data from the multiple ascending dose (MAD) portion of the study.
Dr. Mikol stated, “The Phase 1 study is progressing very well, and we are encouraged by the data we are seeing so far. 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. Following a thorough safety evaluation, including a blinded review of adverse events, vital signs and laboratory data, the Safety Review Committee approved advancing to the second 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 each other and to those for the same dose level in the SAD portion of the Phase 1 study. A reproducible pharmacokinetic profile is a highly desirable property for any drug being developed for human use.”
Paul Brennan, NervGen’s President & CEO, stated, “The results we are seeing in our Phase 1 study continue to be very promising. 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. We have now proceeded to evaluate a higher dose level in the second MAD cohort and 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 patients later in 2022.”
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.
For further information, please contact:
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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: our plans to present blinded and unblinded data from our Phase 1 clinical trial at the 2022 American Academy of Neurology Annual Meeting; the timing of the clinical development of NVG-291; the objectives, timing and study design of the Phase 1 study in healthy volunteers; the timing and requirements 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 SAD 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.
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