Revive Therapeutics returns with repurposed gout drug to fight COVID-19 and push into psychedelic medicine

Specialty life sciences company focused on developing drugs for rare disorders and infectious diseases Advancing clinical development of gout drug Bucillamine for infectious diseases, including COVID-19 Developing novel psilocybin and cannabidiol therapeutics for central nervous system and inflammatory disorders What Revive Therapeutics does:  Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) is a life sciences company focused on the research and development of drugs for infectious diseases as well as central nervous system and inflammatory disorders. Its cannabinoid pharmaceutical portfolio focuses on rare inflammatory areas such as liver disease. The company has been granted orphan drug status designation by the US Food and Drug Administration (FDA) for the use of CBD to treat auto-immune hepatitis and FDA orphan drug status designation for the use of CBD to treat ischemia and reperfusion injury from organ transplantations. The Ontario-based company is also advancing the development of psychedelic medicine with psilocybin-based therapeutics to fight addictions and depression.   Revive just recently joined the fight against the coronavirus (COVID-19) disease, which is caused by the SARS-CoV-2 virus, by repurposing its long-established, US government-approved rheumatoid arthritis treatment Bucillamine as a possible treatment for infected patients suffering from inflammation in their lungs.  How it is doing: In late June, Revive submitted its Investigational New Drug (IND) application package for the FDA to launch a Phase 3 confirmatory clinical trial to evaluate Bucillamine in the treatment of patients with mild-to-moderate COVID-19. The FDA has asked Revive to submit the IND based on its Phase 2 study of Bucillamine as an anti-inflammatory treatment for gout. If approved, the study is slated to begin in the third quarter of 2020 and will focus on treating the destructive effects of lung inflammation. It will be a multicenter, randomized, double-blind, placebo-controlled trial, with a primary objective to compare the frequency of hospitalization and mortality.  A minimum of 210 symptomatic patients will initially be randomized 1:1:1 to receive Bucillamine 300 milligrams/day, Bucillamine 600 mg/day, or a placebo. Patients will then be randomized 2:1 to receive the selected Bucillamine dose and placebo. Interim analyses will occur every 100 subjects up to the maximum sample size of 800 people. An independent data safety monitoring board will actively monitor interim data for the safety of the patients.  At the same time, Revive is working with Health Canada to design a parallel clinical study of Bucillamine to treat coronavirus patients. The company in June held discussions with agency officials about the information Revive must submit in its Clinical Trial Application (CTA) package. Much of the CTA info will be based on the US trial. Along with COVID, the company is advancing the development of its oral dosage forms of psilocybin -- the chemical found in so-called magic mushrooms, which may be used to treat a variety of diseases and disorders. Revive says psilocybin has the potential to be as popular as cannabis in the biopharma space. Revive recently acquired Psilocin Pharma in an all-paper deal worth $2.75 million. Psilocin has developed its own production processes and a number of psilocybin-based formulations to be targeted for clinical research for the treatment of depression, anxiety, bi-polar disorder, bulimia, and others. The company also recently struck a research partnership with the University of Wisconsin-Madison and a collaboration deal with Phytochemical Solutions LLC, which is a spin-off company of the university. These partnerships will focus on delivery systems that can provide precise dosing of psilocybin and controlled release via pens and gumdrops, capsules, sublingual spray, gel gaps, and dissolvable thin film strips on the tongue. Revive also plans to finalize a sponsorship program around a Phase 1 clinical study examining psilocybin for the treatment of an undisclosed addiction-use disorder. The clinical study will be conducted at the university, which holds a US Drug Enforcement Administration license to perform clinical research with psilocybin. Inflection points: Initiate Phase 3 study of Bucillamine in 3Q to treat COVID-19 Hold a pre-IND meeting with the FDA for psilocybin in 3Q Submit IND for Phase 2 clinical study of CBD to treat autoimmune hepatitis in 4Q What the analyst says: Proactive Research analyst Ed Stacey, in an initiation note on June 30, said that Revive's three therapeutics under development -- Bucillamine, psilocybin and CBD -- represent a potential market opportunity worth hundreds of millions of dollars. "During the next 12-18 months Revive will approach significant milestones for several aspects of its research and development programmes, including the Phase 3 trial for BUC (Bucillamine), and applications for Orphan Drug status for its psilocybin-based therapies," he wrote.  "We believe that these events could represent significant upside catalysts for the share price." What the boss says:  “As part of our psychedelic-based pharmaceutical strategy, we are focused on balancing research and development of novel psilocybin-based formulations and clinical research of psilocybin to create a robust product pipeline backed by intellectual property and clinical data with the aim to pursue the FDA regulatory pathway for commercialization," said Revive CEO Michael Frank. "Revive plans to expand its clinical development pipeline with psilocybin for various addiction and dependence disorders.”