Revive Therapeutics has repurposed gout drug to fight coronavirus and is pushing 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 has also 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: Revive Therapeutics has been making progress on both fronts in 2021. In late March, the company told investors it was on track to meet its planned goal of enrolling up to 1,000 patients in its Phase 3 clinical trial for Bucillamine in coronavirus (COVID-19) in the second quarter of the year. Revive noted that it was currently partnered with 14 clinical sites in six US states, including California, Florida, Illinois, Nevada, North Carolina and Texas, and was expanding that to up to 50 clinical sites to include coronavirus (COVID-19) 'hot spot' states such as Massachusetts, Michigan, New Jersey, New York, Pennsylvania, and South Carolina. This Phase 3 confirmatory clinical trial will study Bucillamine in patients with mild to moderate COVID-19 and will enroll up to 1,000 patients who will be randomized to Bucillamine or a placebo for up to 14 days, the company said, with the main aim is to compare the frequency of hospitalization or death for those receiving Bucillamine therapy with those receiving placebo. Revive noted then that, so far, there had been no serious adverse events or safety concerns that required the Independent to be notified or take action. It also noted that it had recently approached the Food and Drug Administration (FDA) on a potential filing of an Emergency Use Authorization (EUA) application, while the trial is ongoing, so as to receive this approval before the study is completed. Away from coronavirus, Revive said in February that it had signed an asset purchase agreement with Newscope Capital Corporation to acquire the full rights to PharmaTher Inc.’s intellectual property relating to psilocybin for an aggregate consideration of up to C$10 million.  Then in March, Revive announced positive results of a pre-clinical study evaluating the efficacy of psilocybin in the treatment of mild traumatic brain injury (TBI) in a rodent model. The company said the study was conducted at the National Health Research Institutes (NHRI), which was part of the psilocybin program acquired from PharmaTher Inc, a subsidiary of Newscope Capital Corporation. The study characterized the potential neuroreparative effect of psilocybin compared to being treated with a vehicle (saline) using a TBI mouse model. Revive noted that researchers found that psilocybin, given after injury, improved cognitive function in TBI mice. Also, there were no adverse effects observed with psilocybin. Following the acquisition of the provisional patent application from PharmaTher (Psilocybin in the Treatment of Neurological Brain Injury), and rthe positive research results with psilocybin in the TBI model, Revive said it had filed an international Patent Cooperation Treaty application allowing it to seek protection of this invention in 153 countries, including the US, Europe, Canada, Japan, and China. In January, Revive announced that it had entered into a sponsored research and an exclusive option-to-license agreement with North Carolina State University to develop a novel biosynthetic version of psilocybin. It is based on a natural biosynthesis enzymatic platform developed by NC State professor and researcher Dr Gavin Williams and provides a potentially simple and efficient method for rapidly producing natural products -- such as psilocybin -- using an engineered enzymatic pathway in E. coli.  Revive said it is seeking to develop and commercialize its own pharmaceutical-grade psilocybin with this biosynthesis technology at scale to support the company’s current psilocybin-based product pipeline that includes an oral thin film product currently being developed in collaboration with the University of Wisconsin-Madison and the intellectual property and research with psilocybin being developed by PharmaTher.  On the financing front, in February, Revive closed a previously announced bought deal prospectus offering of 46,000,000 units at a price of $0.50 per unit for aggregate gross proceeds of $23 million, which included the exercise in full of the 15% over-allotment option. The company said it intended to use the net proceeds for Phase 3 ‎clinical costs for Bucillamine for coronavirus (COVID-19), Phase 1 clinical ‎costs for Psilocybin for methamphetamine use disorder ‎study, and other Psychedelic formulation development work ‎as well as working capital and general corporate purposes.  On the personnel front, at the end of December 2020, Revive announced the appointment of Dr John Fahy as a Scientific and Clinical advisor to the company. It said he will assist in the expansion and analysis of the clinical data on the ongoing US Food & Drug Administration (FDA) Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19.  Dr Fahy is a Professor of Medicine in the Division of Pulmonary and Critical Care Medicine and the Department of Medicine at the University of California San Francisco and is a director of UCSF’s severe asthma clinic. And in January, Revive shares got a boost from the news that it was one of the 17 companies in the US and Canada that were included in the first psychedelics exchange-traded fund (ETF) managed by Horizons ETF Management. The Horizons Psychedelic Stock Index ETF index started trading on January 26, under the ticker PSYK on the NEO exchange.        Inflection points: More news on Phase 3 clinical trial for Bucillamine in coronavirus Phase 1 clinical ‎costs for Psilocybin for methamphetamine use disorder ‎study Other Psychedelic formulation development work What the boss says:  In a February 2021 statement regarding the clinical trial for Bucillamine in coronavirus, Revive CEO Michael Frank said: “With our funding completed, we are adding more clinical sites to meet our enrollment goals and be in a position to meet with the FDA to determine the best path forward for EUA approval." “We are committed to achieving our mission in making Bucillamine the first orally administered drug to obtain FDA approval and EUA to treat mild to moderate COVID-19,” he added. Contact the author at jon.hopkins@proactiveinvestors.com