Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS), a company that focuses on repurposing drugs for infectious diseases and rare disorders, is preparing to submit to the U.S. Food and Drug Administration (FDA) an Investigational New Drug (IND) application for a Phase 3 confirmatory trial to evaluate Bucillamine in patients with mild to moderate Covid-19.
The drug has a long history, having been used in Japan and South Korea for over 30 years for rheumatoid arthritis. Revive has a clinical history with the drug, repurposing it to conduct a Phase 2 trial in the United States in 2015 for acute gout flares and cystinuria, a form of kidney stones. While it never went to market, Revive possesses substantial data on its safety and efficacy.
"Bucillamine as an agent has a lot of strength in terms of anti-inflammatory advantages," Michael Frank, chairman and CEO of Revive Therapeutics, told Streetwise Reports. "From its long use in Japan and South Korea, it has a lot of good history, and good safety and efficacy background. Additionally, from our Phase 2 study for gout, we had a lot of data to support its safety as well as its inflammation treatment properties."
Earlier this year, with the advent of the Covid-19 pandemic, Revive looked at Bucillamine again. "There's a lot of data to support that Bucillamine is much more powerful as an anti-inflammatory. It can help restore glutathione, which is an amino acid in the body that can help reduce inflammation. Bucillamine has a strong indication of possibly treating symptoms like lung inflammation caused by infectious diseases from specific strains of influenza, H1N1 and coronavirus, namely Covid-19," Frank explained.
Revive in April filed a pre-investigational new drug meeting request with the FDA for Bucillamine for the treatment of Covid-19 to proceed to a Phase 2 clinical study. The FDA recommended that the company submit its IND for a Phase 3 confirmatory trial.
The basis of the clinical study will analyze if "Bucillamine has the potential, via restoration of glutathione activity and other anti-inflammatory activity, to lessen the negative consequences of SARS-CoV2 infection in the lungs and to help treat Covid-19 manifestation," Frank stated.
"The FDA agreed that Revive could rely on its data included in its previous IND with Bucillamine for gout to support the Covid-19 Phase 3 trial and, therefore, the company did not have to perform any Phase 1 or Phase 2 clinical studies," the company reported.
"Because of our history with Bucillamine, and that Bucillamine has been around 30 years and it's been effective in South Korea and Japan treating rheumatoid arthritis, and because of the data, we were asked to provide an IND to go directly to a Phase 3 trial—a much bigger trial," Frank said.
"FDA's support in advising Revive to move directly into a Phase 3 confirmatory trial provides an acknowledgment for the potential of Bucillamine in the treatment of Covid-19,' noted Frank. "Entering into a Phase 3 study is a major milestone for the company, and we are excited to unlock the full potential of Bucillamine not only for this virus but also for other infectious diseases that we will investigate in the future."
Revive has also stated that it intends to conduct a clinical study of Bucillamine in Covid-19 patients in Canada and today announced that it has submitted a Pre-Clinical Trial Application (Pre-CTA) to Health Canada and will have its Pre-CTA meeting with Health Canada this week.
"Unlike many micro caps in Canada and in the United States, getting to Phase 3 trial is a substantial plateau, and that's what sets us apart," Frank added.
Revive is also actively investigating psilocybin-based therapeutics. The firm, which acquired Psilocin Pharma Corp., is investigating "novel oral dosage forms of psilocybin, such as oral dissolvable thin films or tablets, based on the company's wholly owned patent-pending psilocybin formulations and its exclusive licensed drug delivery technology from the Wisconsin Alumni Research Foundation."
"We are expanding our psilocybin-based pharmaceutical portfolio with unique oral dosage and drug delivery forms that will target and have the potential to treat diseases and disorders currently not investigated with psychedelic compounds," Frank said. "We are combining our robust intellectual property portfolio in both psychedelic formulations and our drug delivery technology which is unique within the industry, and leveraging our research partnership with the University of Wisconsin-Madison to establish a specialty portfolio of psilocybin-based pharmaceuticals that we can advance to clinical trials and partnerships with other life sciences companies."
The company is targeting rare diseases, mental health and addiction with the psilocybin formulations.
Revive has approximately 189 million shares outstanding, 267 million fully diluted.
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