Revive Therapeutics Announces U.S. FDA Recommendation to Proceed Directly Into A Phase 3 Confirmatory Clinical Trial

TORONTO, April 23, 2020 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today that it has received positive feedback from the U.S. Food and Drug Administration (“FDA”) in response to the Company’s Pre-Investigational New Drug (“pre-IND”) meeting that was announced on April 3, 2020. The FDA recommended that the Company proceed directly into a Phase 3 confirmatory clinical trial (“Phase 3 study”) to evaluate Bucillamine for the treatment of patients with mild-moderate COVID-19 due to the SARS-CoV-2 infection in order to ensure expeditious evaluation of the safety and efficacy of Bucillamine.

“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,” said Michael Frank, Chief Executive Officer of Revive. "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.”

In addition to its recommendation, the FDA provided valuable guidance on study design and outcome measures for the Phase 3 study.  Importantly, 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 study and, therefore, the Company did not have to perform any Phase 1 or Phase 2 clinical studies.  The Company, along with its Contract Research Organization, Pharm-Olam, LLC, and its clinical development team led by Dr. Kelly McKee, Jr., MD, MPH, Chief Scientific Officer consultant and Dr. Onesmo Mpanju, PhD, Regulatory Affairs consultant, are actively incorporating the pre-IND meeting guidance and preparing the package for submission to the FDA.  The Company expects to file the final IND within the next 60 days and will plan to initiate the Phase 3 study thereafter.

Scientific Rationale of Bucillamine

Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.¹ N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to restore antioxidant and to reduce the activity of cellular glutathione ^2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC ⁶. The drug is non-toxic with high cellular permeability. 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 manifestations.