Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) announced the launch of a new clinical research program that will evaluate the use of the drug Ifenprodil (NP-120) in treating pancreatic cancer. The announcement followed the positive results of a study that demonstrated Ifenprodil's significant anti-tumor effect in an animal model of pancreatic cancer. It is one of several projects Algernon is pursuing related to Ifenprodil, an NMDA (N-methyl-D-aspartate) receptor antagonist, that is used in Japan to treat vertigo.
Rather than developing drugs from scratch, Algernon Pharmaceuticals is a clinical stage drug development company that "repurposes" existing drugs for new therapeutic uses. Repurposing is a more rigorous effort than off-label prescribing. "An off-label use is the decision of an individual physician, with limited safeguards in place," said CEO Christopher Moreau. "Repurposing involves an entity, like Algernon, investing its time, effort and resources to find and study the mechanism of action of existing drugs and to seek formal regulatory approval for new possible uses."
This business model takes already approved and proven safe drugs, including naturally occurring compounds, and screens them in globally accepted animal models to treat different diseases. When the results warrant, the company then files new intellectual property rights and moves the drugs into clinical trials. The potential benefits of repurposing compared to traditional drug development include reduced investment and risk, shorter research periods and a longer active patent life.
Algernon focuses on drugs that have not previously been approved in the U.S. or the E.U. The company prefers drugs approved in places like Japan and Russia because, Moreau said, "that insulates us from facing any off-label prescription writing issues and provides us a stronger period of exclusivity."
He went on to say that the firm's repurposing strategy can save up to "five years and many millions in R&D costs. Repurposing costs approximately one-tenth the cost of developing a new drug, and you also have to remember that 90% of new drugs fail before they ever get to human testing."
Furthermore, repurposed compounds have a much lower risk of failing in human trials due to safety issues. "The drugs we are developing have proven safety records, reducing safety risk," Moreau said. "We are able to conduct multiple Phase 2 clinical trials with multiple drugs for multiple indications at the same time, increasing our capital efficiency and accelerating time to market."
Right now, Algernon's Ifenprodil pipeline involves research into its use in treating:
- Idiopathic pulmonary fibrosis (IPF): This lung disease scars the lungs irreversibly, reducing the ability to breathe. Its cause is unknown, yet it affects up to 132,00 people in the U.S., with 50,000 new cases diagnosed annually, according to the American Lung Association. Algernon has Phase 2 human studies underway on the efficacy of Ifenprodil to treat IPF in Australia and New Zealand. The IPF market is expected to rise from $900 million (2015) to $3.2 billion by 2025.
- Chronic cough: An intermittent cough is annoying; a cough that lasts longer than eight weeks can contribute to insomnia, nausea, even rib fractures, according to the Mayo Clinic. Algernon is exploring Ifenprodil's ability to calm the inflammation associated with this condition. Whether as a standalone condition or a symptom of IPF or other lung disease, chronic cough represents a global market of $1.40 billion.
- Pancreatic cancer: Although not as widespread as other cancers, pancreatic cancer is more deadly, killing approximately 40,000 people in the U.S. alone each year. And it kills quickly: The five-year survival rate hovers around 7%. Algernon is preparing to request a pre-investigational new drug application (pre-IND) meeting with the FDA. The firm also plans to file for an orphan disease designation and seek both Fast Track status and designation as a Breakthrough Therapy. These steps all would accelerate the pace toward beginning human clinical trials. Grand View Research estimates the global pancreatic cancer treatment market will reach $4.2 billion by 2025, driven in part by the burgeoning population aged 65 to 75 that is most at risk for the disease.
Algernon also has ongoing research into the use of the psychedelic DMT to treat stroke, and expects to begin its Phase 1 human study the end of this year. "The company's decision to investigate DMT for stroke is based on multiple independent, positive preclinical studies demonstrating that DMT helps promote neurogenesis as well as structural and functional neural plasticity. These are key factors involved in the brain's ability to form and reorganize synaptic connections, which are needed for healing following a brain injury," Moreau explained.
The firm's competitors in the area of drug repurposing include Rediscover Life Sciences, Paradigm, Chord Therapeutics and Exvastat. Companies active in the psychedelic space are PsyBio Therapeutics, MindMed and PharmaTher.
Fans of science fiction may appreciate the company's nod to the Hugo award-winning short story, and later novel Flowers for Algernon, in its choice of name. Made into the movie Charly, the plot hinges on a surgical technique that appears to increase intelligence and its effect on both a human subject, Charlie, and the mouse of the title.
Algernon is covered by Andrť Uddin of Research Capital Corp., which has rated it Speculative Buy and assigned a target price of CA$0.25. The stock is currently trading at around CA$0.13.
Algernon's market cap is approximately CA$22.5 million, with 170 million shares outstanding.
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Disclosures from Mackie Research Capital Corp., Algernon Pharmaceuticals Inc., Update, May 10, 2021
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