NervGen Pharma Corporation (QX) News - NGENF

Is this stunning "evidence" that NervGen has the goods?
https://stockhouse.com/opinion/contributors/2024/02/01/is-this-stunning-evidence-that-nervgen-has-goods

This could be the signal that tiny NervGen Pharma Corp. (TSX-V: NGEN; OTCQX: NGENF) is destined to be one of the top performing biotech startup stocks this year.

It came in a seemingly innocuous podcast interview about the company’s ongoing Phase 1b/2a “proof of concept” human trials. In online investment chat groups, they’re saying that the podcast offered up a bombshell revelation – that extraordinary therapeutic improvements are apparently being achieved by paralyzed trial volunteers.

Simply stated, at least a couple of trial participants may apparently be regaining the use of their limbs – albeit incrementally.

This sneak peek inside this randomized double-blind, placebo-controlled trial has major implications.

Something quite remarkable appears to be happening at Chicago’s Shirley Ryan AbilityLab – a global leader in physical rehabilitation for patients with severe nerve damage. This is where at least one of the initial trial patients – mindful that there are only a handful of trial volunteers in total so far – is apparently regaining some function of his extremities, even though he suffers from chronic spinal paralysis.

This stunning revelation was shared by a globally-renowned podcaster called Louise Phipps Senft, who runs a non-profit advocacy/support organization for spinal cord injury victims called Blink of An Eye, which is based in Baltimore. She said in a December 20th podcast(minutes 42.10-42.41) that one of NervGen’s trial volunteers — who enrolled with the support of her organization – began to experience noticeable improvements after only a few once-a-day injections.

This volunteer has been administered NervGen’s experimental peptide called NVG-291 as part of a 12-week trial program that officially got underway late last year. It’s the first of its kind for humans. And that’s why the trial is being so closely watched by the medical community and investors alike.

Any suggestion that trial volunteers are getting remarkable results within weeks, rather than months, would not come a surprise to NervGen’s scientists. In the past, they have successfully used NVG-291 in numerous preclinical trials to achieve substantial and unprecedented recovery of functionality of laboratory rodents that had sustained severe spinal cord damage.

They also proved that NVG-291 is not toxic to these animals, even in high doses. This is one of the official reasons why this drug candidate has recently been fast-tracked by the FDA in human trials. Unofficially, it might be because FDA medical scientists have become aware that NVG-291 appears to be working already. Either way, this fast-tracking by the regulators represents another key signal to investors that the company’s share price may be getting primed for a sustained rally in 2024.

“Proof of Concept” Trial: Where there is smoke, is there fire?
Admittedly, it’s a big leap to hope for comparable results in humans to laboratory animals. But this seems to be what’s happening already with at least one of the trial’s first patients. This is mindful of the fact that he doesn’t know whether he’s being injected with the trial drug candidate or a placebo.

Importantly, these volunteers have a “chronic” injury that is between one and 5 years old. Apparently, there are no records of humans having significant recovery beyond 12-18 months post-injury. It would be almost miraculous if a patient getting the placebo experienced any noticeable improvement.

However, if a patient becomes able to move his digits during the trial, this represents a huge breakthrough for NervGen.

Consider the fact that the trial’s researchers set out with far more modest aspirations, which was to use electrical stimuli to detect subtle improvements in muscle functionality and limb mobility. Even the tiniest of improvements in that regard would be considered something of a success. But if patients can exhibit observable movement in response to the treatment, that’s by far a best-case scenario – one that appears to be playing out.

For anyone interested in the technical explanation of how trial results are measured, here it is: The primary endpoint is to show improvement of the body’s “electrophysiology”, or natural electrical impulses, according to NervGen’s trial scientists.

Functional improvements are secondary (even more desirable) endpoints. So if a volunteer is experiencing improved functionality, this means that the primary endpoint of increased electrical impulses has been successfully achieved, pointing to a successful trial.

Of course, no official comment can be expected from NervGen or from Shirley Ryan AbilityLab until much later this year after all the trial data readouts have been fully assessed. So the countdown has started to a pending trial outcome announcement that will surely have a major impact on NervGen’s share price. As of now, NervGen may then be just a few months away from a serious stock re-rating.

Here’s Why NVG-291 has “Blockbuster” Drug Potential
In terms of the Big Picture, NervGen believes that NVG-291 has the potential to be a revolutionary “blockbuster” treatment for all kinds of nerve and neuron damage, not just spinal cord injuries. This is mindful of the fact that no drugs have ever before been approved anywhere in the world for nerve regeneration and for improving plasticity in damaged nerves.

NervGen is also hoping to treat other conditions like MS and stroke, thanks to an extraordinarily strong collection of animal data. This means that NVG-291 might also be able to treat conditions as devastating to society as Alzheimer’s disease — an affliction involving 6 million Americans, which costs the US $350 billion a year to manage.

NervGen should complete the Phase 1b/2a trial later this year, which includes a post-trial evaluation. The trial will involve 20 people, who each receive a once-a-day injection for 12 weeks. Half receive the drug candidate and the other half receive a placebo.

It’s statistically significant that more than just the one trial volunteer is making what is being referred to as exciting progress by Meghan Morrow, who is the project manager for NervGen’s trial.

This was Morrow’s assessment when she was being interviewed last December on Louise Phipps Senft’s podcast about NervGen. And even though Morrow is professionally obliged to keep her cards close to her chest about the trial’s progress, she did offer the following tantalizing insight as to its possible outcome.

“It is a double-blind trial. So no one knows anything, except the pharmacist…But I will say that obviously there is speculation when we see individuals making gains. And then we get really excited…”

Key Investment Takeaways
A few savvy investors were quick to digest the implications of this podcast’s revelations, and the share price shot up accordingly on heavy volume soon after it aired. But now the stock is settling down again on normal volume, forming a new, higher price base ahead of its next anticipated up-leg. Whether that happens before or after the announcement of Phase 1b/2a trial results remains to be seen.

For now, NervGen continues to remain under the radar for most investors due to the company’s low-key public profile. The stock is accordingly still undervalued considering how far NervGen has come in validating the efficacy of NVG-291. And the prospect of continued success in human trials would surely send the company’s share price surging to new multiples.

It’s also worth remembering that the US federal government is encouraging NervGen’s progress too with its recent awarding of a Fast Track designation for trials. But this may not be such a surprise development to NVG-291’s co-inventor, Dr. Jerry Silver. He was quoted on a different podcast in late November, 2023 as saying that he expects human trial volunteers to respond as quickly to treatment as the animals did, which produced remarkable results within just a few weeks.

Click to enlarge
Dr. Jerry Silver, co-inventor of NVG-291. Image credit: NervGen
“Now when we give the peptide or the enzyme, those connections that are smothered wake up very rapidly. Do you remember when you asked me how long it would take for people to get better? And I said it would happen very quickly within weeks. That’s what we’ve seen,” Dr. Silver said.

The following few months promise to be last chance for investors to see NervGen remain undervalued and largely overlooked by most risk-tolerant investors. But if paralyzed trial volunteers keep improving, the announcement of such stunning results later this year would surely thrust NervGen in the investment limelight – setting the stage for a remarkable performance.

Disclosure:
The author of this article or members of his household or family, do not own shares in NervGen at this time. However, he may from time to time buy or sell shares in companies that are profiled in his various investment articles. Additionally, he is not compensated by the company directly or indirectly. His commentary is therefore based solely on his personal research and understanding of the life sciences sector. It is not intended as investment advice.

The material provided in this article is for information only and should not be treated as investment advice. For full disclaimer information, please click here.

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https://nervgen.com/nervgen-pharma-announces-first-subject-dosed-in-landmark-phase-1b-2a-clinical-trial-for-nvg-291-in-spinal-cord-injury/

Chronic spinal cord injury cohort results expected in mid-2024
Subacute spinal cord injury cohort results expected in late 2024/early 2025

Vancouver, Canada, September 25, 2023 – NervGen Pharma Corp. (TSX-V: NGEN; OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced the first subject has been dosed in the Company’s landmark Phase 1b/2a proof-of-concept placebo-controlled clinical trial for its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI).

“This is a significant milestone for NervGen and also an exciting day for individuals with spinal cord injury as we progress this first-in-kind product candidate into clinical studies,” said Mike Kelly, NervGen’s President & CEO. “This unique trial design will allow us to evaluate NVG-291’s efficacy independently for each cohort of subjects – subacute and chronic. We believe the results of this research study will be a key enabling step that may bring us closer to the first approved therapy for spinal cord injury, and we look forward to the prospect of delivering positive results next summer.”

Given there are approximately 300,000 people with SCI living in the United States alone, the limited number of clinical trials in this area and the tremendous anticipation for this trial within the SCI community, recruitment for the chronic cohort (1-10 years post injury) is anticipated to happen relatively quickly with results expected by mid-2024. Results from the subacute cohort (10-49 days post-injury) are expected in late 2024/early 2025. The trial is being conducted at Shirley Ryan AbilityLab in Chicago, a global leader in physical medicine and rehabilitation for adults and children with the most severe and complex conditions.

“Our team at Shirley Ryan AbilityLab is excited to have begun investigational treatment in this important clinical research trial in individuals with spinal cord injury,” 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; Research Scientist at the Edward Hines Jr. VA Hospital; and the principal investigator of this trial. “We look forward to fully recruiting this study and executing upon this innovative trial, which has the potential to change how we design and implement SCI clinical studies in the future.”

About the NVG-291 Phase 1b/2a Trial

The placebo-controlled proof-of-concept trial (NCT05965700) will evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (10-49 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. Specifically, the primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential amplitudes. Secondary objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function, upper extremity dexterity and grasping and mobility, as well as changes in additional electrophysiological measurements. Each cohort will be evaluated independently as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is to be provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial.

About Shirley Ryan AbilityLab

Shirley Ryan AbilityLab, formerly the Rehabilitation Institute of Chicago (RIC), is the global leader in physical medicine and rehabilitation for adults and children with the most severe, complex conditions – 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 RIC in 1953. The quality of its care has led to the designation of “No. 1 Rehabilitation Hospital in America” by U.S. News & World Report every year since 1991. Upon opening in 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 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. Shirley Ryan AbilityLab is a 501 (c)(3) non-profit organization. For more information, go to www.sralab.org.

About Wings for Life Accelerated Translational Program

Even with very promising discoveries, the translation from scientific discovery to applied therapeutics is a long and difficult road due to regulatory burdens, complexities of clinical trial design, patient recruitment and retention barriers, and the high cost of cutting-edge research. The Wings for Life Accelerated Translational Program (ATP) has been specifically designed to be able to accommodate obstacles to efficient clinical translation.

The ATP strives to assist applicants to find the best way forward in clinical translation of high caliber, promising therapies. The ATP is supported by a network of clinicians, scientists, and other professionals with expertise in all aspects of clinical trials. Select members of the ATP Support Network will be called upon, as required, to assist in ensuring that treatments with auspicious potential are translated in the most scientifically rigorous and efficient way possible.

About NVG-291

NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting mechanisms that interfere with nervous system repair. NVG-291 is derived from the intracellular wedge domain of the receptor type protein tyrosine phosphatase sigma (PTPs). NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of spinal cord injury (acute and chronic intervention), peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination.

About NervGen

NervGen (TSX-V: NGEN, OTCQX: NGENF) is a clinical stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. NervGen’s lead drug candidate, NVG-291, is being evaluated in a Phase 1b/2a clinical trial. The Company’s initial target indication is spinal cord injury. For more information, go to www.nervgen.com and follow NervGen on Twitter, LinkedIn, and Facebook for the latest news on the Company.

Contacts

Huitt Tracey, Corporate Communications
htracey@nervgen.com
604.537.2094

Nancy Thompson, Vorticom Public Relations
nancyt@vorticom.com
212.532.2208

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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 objectives, timing, rate of subject recruitment and study design of the clinical development of NVG-291 including the planned single site Phase 1b/2a clinical trial in SCI with Shirley Ryan AbilityLab; our belief that the results of the Phase 1b/2a clinical trial will enable us to evaluate NVG-291’s efficacy independently for each cohort of subjects and advance our clinical pathway to approval; the innovative aspect of the trial having the potential to change the design of SCI clinical trials in the future; the receipt of the milestone-based grant payments and the potential assistance from ATP; the belief that targeting mechanisms that interfere with nervous system repair 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, Short Form Base Shelf Prospectus, financial statements and Management Discussion and Analysis which can be found on SEDARplus.ca. 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.

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