Before COVID-19 very few people across the globe knew what re-purposing a drug meant. Hydroxychloroquine, and chloroquine, originally developed as drugs for malaria, were the first widely talked about “older drugs” that were being investigated to treat the world’s worst pandemic in over 100 years. Despite their initial promise, a recent study showed they were unable to prevent a COVID infection and ultimately the U.S. FDA revoked its emergency use authorization for the drugs for the treatment of Covid-19.
Drug re-purposing, finding a new use for off patent drugs, has many obvious benefits, including being able to move a drug quickly into new human trials because the toxicity profile and safety history are already known. But above all, it needs to be proven that the drug can treat a different disease than what it was originally intended for, first in animal studies, and then in humans. It is also a very capital efficient approach to drug discovery.
Next up was Remdesivir, Gilead’s (NASDAQ: GILD) previously developed wide spectrum anti-viral drug, originally developed for hepatitis C, then Ebola, showing in a major study that it reduced confirmed COVID patients’ days in the hospital by 30%. However, it did little to reduce the viral load in the blood and did not reduce mortality with any statistical significance. While the U.S. FDA moved to approve it quickly as a treatment, clinicians are hoping for better solutions as research continues.
Now its Ifenprodil’s turn on the world stage. Initially developed by Sanofi for intermittent claudication (a condition where your leg muscles don’t get enough blood during exercise), this NMDA receptor antagonist is set to test against a pathogen that has shut the world’s economy down, infecting more than 20M and killing over 736K people world wide. A recent independent study at UT Dallas identified Ifenprodil as a possible treatment for COVID and a lead researcher of the study commented that a drug with Ifenprodil’s mechanism of action could possibly reverse the pathology of the disease.
Ifenprodil’s chance at a new life is being advanced by a relatively unknown, small publically traded Canadian biotech company called Algernon Pharmaceuticals. (CSE: AGN; OTC: AGNPF) Named after the 1959 Hugo award winning science fiction novel, the Company is betting that this quiet and unassuming safe generic drug may soon become a global blockbuster. The Company is claiming it has filed new patents globally for Ifenprodil for the treatment of respiratory diseases. Algernon has advised that they are following the same re-purposed drug business model as Biogen with their re-purposed drug Tecfidera and Celgene’s Thalidomide, both billion dollar blockbuster drugs in their own right.
Ifenprodil’s COVID potential is based on robust animal data from a study of the world’s most lethal avian respiratory flu virus which shares a similar pathology to COVID. In an independent mouse study of H5N1, (it has a 60% mortality rate in humans) Ifenprodil reduced mortality by 40% and reduced acute lung injury and inflammation.
In a separate animal lung study of idiopathic pulmonary fibrosis, Ifenprodil also outperformed both Roche’s and Boehringer Ingelheim’s leading drugs, Pirfenidone and Nintedanib respectively, reducing fibrosis (scarring) by 56%. It is notable that both treatments reportedly reached a cost of US $90K per year each. Ifenprodil also showed its ability as an anti-tussive outperforming Merck’s Phase 3 anti-cough drug Gefapixant in a separate animal study by 110%.
The Company recently announced the first patient has been enrolled in its multinational human Phase 2b/3 COVID trial for Ifenprodil. The Phase 2b part of the study will see 150 hospitalized confirmed COVID patients enrolled with 50 remaining untreated, 50 receiving a lose dose of Ifenprodil and 50 receiving a high dose of Ifenprodil. If the key endpoints are achieved, the study will move seamlessly into a phase 3 trial with the potential of moving on to market approval. Phase 2b data is expected before the end of 2020.
Can Ifenprodil reduce the severity and duration of a COVID-19 infection? Will it reduce mortality like it did in the worlds’ most lethal flu? Will it reduce acute lung injury an inflammation that can cause the cytokine storm associated with the most serious of COVID cases?
Time will tell…
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