Revive Therapeutics (CSE: RVV) (OTC: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced that is has received approval from the independent Institutional Review Board (“IRB”) for one of its programs. The program is Revive’s expanded access protocol (“EAP”) for compassionate use of Bucillamine in the treatment of COVID-19. The EAP comprises a multi-center, open-label study of Bucillamine in hospitalized patients suffering from severe COVID-19. The study calls for patients to receive Bucillamine 200 mg orally, three times a day for up to 14 days. Patients will be monitored to evaluate the safety and efficacy of Bucillamine at that dosage. Follow-up safety assessments will also be performed. “With the IRB approval of the expanded access protocol by Advarra, a premier IRB services company in North America, hospitalized patients with severe COVID-19 may access Bucillamine under the FDA compassionate use program under medical supervision by their physician,” Revive CEO Michael Frank stated in the press release. “The EAP serves as an option for patients that are not eligible for inclusion criteria in our Phase 3 clinical study in COVID-19, and the resulting data from the EAP will be valuable in supporting our clinical development of Bucillamine.”
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About Revive Therapeutics Ltd.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug-development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, Revive is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases, and the company was granted FDA orphan drug status designation for the use of cannabidiol (“CBD”) to treat autoimmune hepatitis (liver disease) and reperfusion injury from organ transplantation. For more information about the company, visit www.ReviveThera.com.
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