Revive Therapeutics, a Toronto-based psychedelics and cannabinoid-focused biotech firm, is among a growing number of pharmaceutical and biotech companies racing to provide new and effective COVID-19 treatments.
Known for specialty life-science studies around psychedelics, including the acquisition of Pharmather’s psilocybin pipeline, Revive also develops pharmaceuticals for uncommon diseases, including treatments for rare disorders such as ischemia–reperfusion injury, or IRI, for which it filed an application with the FDA for Orphan Drug Designation for bucillamine to prevent IRI during liver transplantation.
There are presently no medicines approved for IRI. Liver ischemia-reperfusion injury, which occurs when the liver is deprived of oxygen during a transplant, is one of the most common causes of post-transplantation hepatic impairment, resulting in an increased risk of post-operative complications and mortality.
Although many therapeutic approaches have shown promise in experimental settings, most have failed to show effectiveness in real-world applications or in humans. The need is pressing, with 8,906 liver transplants in 2020, according to the United Network for Organ Sharing, and 11,664 people on the waiting list for a liver transplant.
Revive is investigating the use of bucillamine during liver transplantation as a safe way to prevent IRI.
Michael Frank, CEO of Revive said, “We are continuing to advance novel uses of bucillamine not only as a treatment for infectious diseases, but also for rare conditions that have no treatment options such as IRI. The FDA orphan drug application for bucillamine as a potential solution in preventing IRI during liver transplantation and subsequently to other organ transplants complements our overall strategy of developing bucillamine as a strong platform for other conditions.”
The Orphan Drug Act makes it possible for a sponsor to apply for orphan designation in order to use a drug or biological product to treat a rare disease or condition. This status is known as orphan designation, or orphan status. The FDA provides incentives to sponsors who create medicines designed to treat uncommon diseases by giving them ODD status.
Bucillamine is the same treatment Revive is currently invested in as an oral COVID therapeutic.
Larger drug developers have already invested billions on pipelines for oral COVID treatment pills. Pfizer’s medicine reduced by 89 percent the chance of hospitalization or death in adults at risk of severe illness from COVID-19, nearly double the percentage of Merck’s oral antiviral Molnupiravir.
Using bucillamine, Revive announced that it is now in a late FDA Phase 3 study for its oral cure for moderate to severe COVID infections. Unlike the larger pharmaceutical companies’ drugs that seek to slow viral replication itself, bucillamine could also prevent the SARS-COV-2 virus from entering host cells.
Pending positive results in reducing viral load testing, bucillamine could be primed for FDA emergency use authorization, or EUA. If it were to be approved, it would indicate that bucillamine can in fact reduce viral load directly rather than only treating COVID symptoms.
Currently, testing taking place at the University of California, San Francisco campus is being led by Dr. John Fahy, a pulmonologist and director of UCSF’s severe asthma clinic.
Frank continued by saying, “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 millions of people globally,” added Frank.
ODD status could include seven years of marketing exclusivity, tax credits for some clinical drug testing costs, eligibility for grants, and the waiving of the FDA New Drug Application filing fee, which is estimated at USD $2,400,000.