It has the potential to be one of the most disruptive pharmaceutical drug therapies of the modern era, especially for treating Alzheimer’s disease. And that gives it considerable “blockbuster drug” potential – a tantalising opportunity that is only now just becoming apparent.
A Canadian-headquartered biotech start-up,
NervGen Pharma Corp. (TSX-V: NGEN, OTCQX: NGENF, Forum) has just entered into a key research agreement with Sylics Contract Research to study its NVG-291 drug in Alzheimer’s disease models in animals as it prepares for its planned 2022 Phase 1b clinical trial in Alzheimer’s patients. Headquartered in the Netherlands, Sylics specializes in testing novel therapies in the field of neurosciences.
This development comes on the heels of pharmaceutical heavyweight Biogen being granted FDA approval earlier this month to commercialize aducanumab -- a drug that removes amyloid-beta plaques from the brain as a means of slowing the onset of Alzheimer's disease in patients.
Biogen’s share price surged as much as 50% higher on the news to a high of US$427 a share as aducanumab is expected to cost up to US$56,000 per year per patient and there are no label limitations so everyone affected can request it. This approval is in spite of the fact that aducanumab’s effectiveness has been questioned by many Alzheimer’s experts.
The sceptics include Dr. George Perry, the editor-in-chief of the
Journal of Alzheimer's Disease. He is the University Chair in Neurobiology at the University of Texas, San Antonio and is one of the most published and cited researchers in the Alzheimer’s field.
He believes that NervGen’s potential for NVG-291 is what he refers to as a far more “exciting” and potentially effective treatment for Alzheimer’s than Biogen’s controversial new drug.
“I strongly believe that the pharmaceutical industry needs new and novel approaches that can harness more powerful mechanisms of action to create a greater likelihood of achieving convincing cognitive stability or improvements,” he says.
“NervGen's drug candidate leverages a unique and powerful multimodal mechanism of action that has been shown in preclinical studies to increase both autophagy and plasticity while also reducing microglia inflammatory expression, representing an exciting new approach to Alzheimer's disease.”
This is due to the fact that NVG-291 is designed to heal nerve damage by unleashing the body’s natural ability to repair itself. Besides treating Alzheimer’s disease, this new therapy has also shown considerable promise in preclinical studies in the treatment of multiple sclerosis and spinal cord injury.
According to Paul Brennan, NervGen’s CEO, “NVG-291 has the potential to redefine how nervous system damage is treated across multiple indications, whether caused by trauma or chronic disease. This is an important first step to bringing this therapy to patients, and we look forward to completing our ongoing Phase 1 study and moving quickly to treating Alzheimer’s patients.”
“The lack of clinically effective therapeutic treatments for Alzheimer's disease patients, which hasn’t changed despite the FDA approval of aducanumab, remains a significant unmet need and a source of frustration for the millions of patients, despite the approval of Biogen’s aducanumab.”
Brennan further adds, “The medical and economic toll of the disease on patients and their caregivers is devastating. The study with Sylics along with the other preclinical studies that we are conducting and our planned Phase 1b study in Alzheimer's disease are important development milestones for our Alzheimer's program, which, if successful, will provide a meaningful benefit to patients and significant market potential for NervGen."
It is well worth noting that more than 6 million people in the US live with Alzheimer’s, and that number continues to increase each year. In 2021, Alzheimer’s and other dementias will cost the nation $355 billion. The Alzheimer’s Association predicts those costs will rise to $1.1 trillion by 2050.
A Breakthrough Therapy: How NVG-291 Works
Any time there is damage to the nervous system – whether that is via trauma or a neurodegenerative disease such as Alzheimer’s, MS or ALS – scar tissue is formed. The body releases chemicals called CSPGs (chondroitin sulfate proteoglycans) within the scar in order to reduce the damage.
They are initially helpful and play a protective role, but there is also a downside to these CSPGs as over time, they actually go from helping to obstructing the body’s ability to repair itself.
NervGen’s drug candidate, NVG-291, releases this molecular inhibition, resulting in the initiation of multiple repair mechanisms including neuron regeneration and “remyelination”, which involves reversing cellular damage in the scar tissue that envelopes and traps damaged neurons, allowing them to subsequently repair themselves.
Not only does it regenerate damaged neurons, but it also creates entirely new connections, which is known as plasticity.
The co-inventor of NVG-291 is Dr. Jerry Silver, a consultant to NervGen. A renowned spinal cord injury researcher, he has partnered with NervGen and is the first regenerative medicine expert to delve deep into the role of CSPGs. He discovered a neural receptor called PTPσ, which is the primary receptor that recognises CSPGs and is responsible for stopping the nervous system from repairing itself.
Dr. Silver, who serves as Professor of Neurosciences at Case Western Reserve University in Cleveland, Ohio, found an elegant way to curtail the activity of PTPσ, thus promoting the regeneration of damaged nerves.
The compound used to inhibit PTPσ is NVG-291 – NervGen’s novel drug candidate. Multiple studies with animal models show that NVG-291 can improve motor function, sensory function and cognition – essentially the ability to walk, grasp objects, detect heat and recall memories.
Dr. Silver is the recipient of the Ameritec Prize for significant accomplishments toward a cure for paralysis, as well as the Christopher Reeve-Joan Irvine Research Medal (The Reeve-Irvine Medal) for his research into spinal cord injuries.
While Dr. Silver’s decades of work and breakthrough research on CSPGs and PTPσ inhibition was initially focused on spinal cord injury, recent published research and preclinical data on neurodegenerative diseases is just now being recognized by the field for its powerful and broad therapeutic potential.
Investment Summary
NVG-291 shows considerable promise in unlocking a damaged nervous system's natural ability to repair itself representing an especially compelling differentiator for NervGen.
The company therefore believes that NVG-291 has the potential to be a revolutionary treatment for nerve and neuron damage. Whether these conditions are caused by trauma or disease, NVG-291 offers the promise to become a breakthrough therapy with blockbuster drug potential.
As a revolutionary treatment for Alzheimer’s disease, alone, NVG-291, offers the potential to make NervGen a future star of the biotech sector. For instance, just consider the fact that Wall Street analysts are now estimating peak annual sales for Biogen’s new drug will range from $10 billion to $50 billion.
These lofty numbers are supported by the fact that the number of Americans living with Alzheimer's is expected to rise to around 13 million by 2050, according to the Alzheimer’s Association. This is more than double the current number of Alzheimer’s patients in the US.
A key takeaway here is that no drugs have ever before been approved anywhere in the world for nerve regeneration and remyelination, as well as improved plasticity in damaged nerves. This opens up the opportunity for NVG-291 to become a powerful panacea of sorts for a diversity of society’s hardest-to-treat diseases.
Besides Alzheimer’s disease, they also include MS, spinal injury, brain injury, and many more central nervous system diseases lacking effective treatments. Keep in mind the fact that existing treatments for these diseases are often only able to target the symptoms, not the underlying disease progression, itself.
Indeed, the fact that NervGen is addressing a significant unmet medical need for the treatment of nervous system damage due to trauma and diseases means that a very lucrative multi-billion-dollar marketplace beckons.
Yet, with a market capitalization of only about CDN $50 million, NervGen has yet to get on the radar of the mainstream investment community. Sooner or later, this is expected to change as the company edges into the scientific and clinical spotlight in the coming months.
With the benefit of a tight share structure (only 39 million shares outstanding), NervGen is poised for a breakout year in 2021 and a transformative year in 2022. This is based on the assumption of a continuation of good news flow, along with industry and investor recognition, as the company sets out to deliver on its first major developmental milestones.
ABOUT THE AUTHOR: Marc Davis has a deep background in the capital markets spanning 30 years, having mostly worked as an analyst and stock market commentator. He is also a longstanding financial journalist. Over the years, his articles have appeared in dozens of digital publications worldwide. They include USA Today, CBS Money Watch, The Times (UK), Investors’ Business Daily, the Financial Post, Reuters, National Post, Google News, Barron’s, China Daily, Huffington Post, AOL, City A.M. (London), Bloomberg, WallStreetOnline.de (Germany) and the Independent (UK). He has also appeared in business interviews on the BBC, CBC and SKY TV. An enthusiastic shareholder of NervGen, his opinions are therefore biased and should not be relied upon for making investment decisions. Business writer Martin Green also contributed to this article.
FULL DISCLOSURE: NervGen Pharma Corp. is a client of Stockhouse Publishing.