Revive Therapeutics advancing repurposed gout drug to fight coronavirus and 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. Its Phase 3 clinical trial for Bucillamine in coronavirus (COVID-19) currently has 40 sites in 14 US states and is on track to meet its planned patient enrollment goal (1,000 patients) in the third quarter this year. Revive aims to file an Emergency Use Authorization (EUA) with the regulator FDA and the company expects to generate 28-day efficacy data from the study in the next quarter or two. Patients are randomized and given Bucillamine or a placebo for up to 14 days, while the main aim is to compare the frequency of hospitalization or death for those receiving Bucillamine therapy with those receiving placebo. Significantly, in June this year, the company announced a memorandum of understanding (MoU) with India-based specialty pharma Supriya Lifescience Ltd for the manufacturing, clinical registration and commercialization of the drug through Emergency Use Authorization (EUA) in India, a country hit hard by the virus. And in May, it said it had entered into a sponsored research agreement with the University of California, San Francisco (UCSF), to explore using the drug Bucillamine as a treatment. Revive said the agreement would support research in the laboratory of Dr. John Fahy to test the efficacy of Bucillamine in pre-clinical models of COVID-19 and to design protocols that test the utility of the drug in human trials. Away from coronavirus, Revive said, in May this year, that it had entered a feasibility agreement with LTS Lohmann Therapie-Systeme AG to develop and manufacture a proprietary oral psilocybin thin film strip. The oral psilocybin strip fits into the company’s clinical and commercial initiatives to evaluate the psychedelic drug as a treatment for mental illness, as well as neurological and substance abuse disorders. And in February, 2021 revealed 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. A month later, 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 the 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. On the financing front, earlier this year, Revive closed a bought deal prospectus offering of 46 million units at $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. What the broker says:  In a note in July, 2021, investment firm Leede Jones Gable said that the scientific rationale behind the company's rheumatoid arthritis drug Bucillamine being a potential treatment for coronavirus (COVID-19) was based on "solid pharmacologic" data. Leede Jones Gable placed no rating on the Revive stock or a target price but said it was featuring the "small molecule drug developer" as an 'Idea of Interest' within its broader healthcare coverage. Its analysts drew particularly on published research from the University of California San Francisco (UCSF), specifically by lead researcher JH Fahy who has since joined Revive’s scientific/clinical advisory boards. Notably, Bucillamine is a Thiol-based small-molecule drug, which have a long and positive clinical history, highlighted the analysts. "Analogous thiol-containing drugs are approved for other indications, including another cysteine derivative called Nacetylcysteine (NAC) which itself has been suggested to have potential in mitigating COVID-19 symptoms...," they added. "Specific biochemical data from the UCSF study certainly documents how bucillamine could work as a COVID-19 therapy and we therefore believe that investing in Phase III activities is medically justified and we look forward to final data in coming quarters," said analysts. Inflection points: Data from 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:  "We are pleased with the status of 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 patients," said CEO Michael Frank in the company's most recent update. "We have made tremendous progress over the last few months by engaging over 40 clinical sites and completing patient enrollment to meet its completed and future DSMB interim analysis timepoints which will allow for the Study to continue and to have potential to seek EUA approval from the FDA. "We are continuing to add to our clinical site roster in the U.S. and patient enrollment that would expedite the completion of the Phase 3 study. Also, we are in discussions with international pharmaceutical companies seeking to obtain commercialization rights in various countries around the world." Contact the author at giles@proactiveinvestors.com