In July, CNBC’s Meg Tirrelle broke the news on Twitter that Pfizer would be spending up to $1B on a new oral Covid treatment pill. The catch is that Pfizer threw its weight into this treatment without knowing whether or not it would be actually effective. The gamble paid off: Pfizer recently released convincing data showing the pill’s efficacy.
Last Friday, Pfizer said its drug cut by 89% the chance of hospitalization or death for adults at risk of severe disease. That percentage clocks in considerably better than the 50% Merck’s oral antiviral Molnupiravir was able to register on its own. Large pharmaceutical companies made bet that early oral therapeutics were the future of Covid treatment and it’s paying off: not only are the treatment results good, but Pfizer and Merck are being generously bestowed lucrative government contracts while also reaping stock market rewards. Both the market capitalizations of Merck & Co. and Pfizer rose over US $20 billion on the days both companies released their positive Covid endpoint data.
As happened with the Covid vaccine, it’s easy to expect that so-called “Big Pharma” will continue to be the vanguard of such treatments. But smaller pharmaceutical companies, some that focus on more experimental or so-called alternative treatments, have their own plans to capitalize on COVID’s multi-billion dollar annualized sales potential. Revive Therapeutics, a Toronto-based psychedelics, cannabinoid and infectious disease-focused biotech firm, is one of those smaller firms. Revive is currently in a late FDA Phase 3 trial for its oral treatment targeting mild-to-moderate Covid infection, the company announced in October. The trial began in autumn 2020.
Revive is best known for its pursuit psilocybin and cannabinoid-based treatments. In 2020, the company acquired Psilocin Pharma Corp., the work of which is focused on psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases, specifically, and the company was granted FDA orphan drug status designation for the use of CBD to treat liver disease, as well as ischemia and reperfusion injury from organ transplantation.
Specifically, Revive’s would-be Covid treatment hinges on Bucillamine, which has been approved for use in South Korea and Japan for rheumatoid arthritis for the past 30 years. Bucillamine displays strong evidence in vitro of preventing SARS-COV-2 virus docking onto the ACE2 receptors, which is the primary gateway of the SARS-COV-2 virus into human cells. Recent research published on July 1, 2021 confirms thiol-based mucolytics, which similar to Bucillamine, also displayed potent inhibition of SARS-CoV-2-ACE2 binding via disulfide reduction.
So, unlike the antiviral drugs being developed by the larger pharmaceutical companies that seek to address viral replication itself, Bucillamine may address that while also preventing the SARS-COV-2 virus from entering host cells.
Revive has recently decided to incorporate viral load testing for a minimum of 300 patients that will be enrolled in the current Phase 3 study. The viral load will allow Revive to quantify the speed at which Bucillamine can reduce viral infection of patients throughout the course of treatment, thus allowing to understand the most optimal time to introduce Bucillamine in the treatment course and provide confidence in the potential utility and effectiveness of Bucillamine in COVID-19.
Should the company’s gambit of reducing viral load testing prove to be effective, Bucillamine should be in a favorable position to receive emergency use authorization (EUA) with regulations. It would be compelling proof that Bucillamine can indeed arrest viral load directly, not just ameliorate the symptoms of COVID. Ideally, regulators would like to see proof of both mechanisms of action at work to inspire a heightened baseline of efficacy.
Currently, tests are being conducted at The University of California, San Francisco campus to determine how Bucillamine stacks up in this regard. Led by Dr. John Fahy, who is a pulmonologist with a special interest in treating patients with asthma who also serves as director of UCSF’s severe asthma clinic, the research receives funding from credible institutions, like the National Institutes of Health. Covid’s ability to interfere with bronchial airways and oxygen absorption is a major cause of death among patients who succumb to the disease, which is what led Fahy to the study of this treatment, specifically.
Michael Frank, CEO Revive, said, “As we move forward in our Phase 3 study in COVID-19 with the aim to seek EUA approval from the FDA for Bucillamine in the treatment of mild to moderate COVID-19, we are also cognizant of the rapidly changing landscape of COVID-19 specifically with the Delta variant becoming widespread. The incorporation of adding viral load testing to patients in the study, along with our support in the research of the potential utility of thiol-based drugs, like Bucillamine, in the Delta variant of COVID-19, shows our confidence in Bucillamine’s potential as a safe and effective oral treatment for mild to moderate COVID-19.”
“We recognize the market opportunity for Bucillamine and we are in discussions with our manufacturing partners to ensure that billions of Bucillamine tablets can be made available in 2022 to support our future commercialization partners and the millions of people globally,” Frank added.