Mr. Michael Frank reports
REVIVE THERAPEUTICS ENGAGES NOVOTECH AS ASIA-PACIFIC CRO FOR BUCILLAMINE IN THE TREATMENT OF INFECTIOUS DISEASES
Revive Therapeutics Ltd. has retained Novotech to serve as the company's clinical research organization (CRO) to pursue future human clinical studies for bucillamine in the treatment of infectious diseases, including COVID-19 in Asia-Pacific countries.
"We are pleased to have Novotech as part of our team to support us in our global clinical strategy for bucillamine in infectious diseases, which includes COVID-19, and they will work in parallel and complement our initiatives in the U.S., specifically with our recently announced FDA pre-IND meeting request for bucillamine," said Michael Frank, Revive's chief executive officer. "We have assembled an exemplary team of scientific, clinical and regulatory experts with Dr. David Boulware, MD, as our scientific advisor, Dr. Kelly McKee Jr., MD, MPH, as chief scientific officer consultant, Dr. Onesmo Mpanju, PhD, as FDA regulatory affairs consultant, and now with Novotech as our APAC CRO. Novotech will assist our team in exploring the potential for a phase 2 clinical study for bucillamine in the treatment of infectious diseases in the APAC region."
Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells. N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily by donation of thiols to restore antioxidant and to reduce the activity of cellular glutathione. 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. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if bucillamine has the potential, by restoration of glutathione activity and other anti-inflammatory activity, to lessen the negative consequences of influenza and COVID-19 infection in the lungs, and to help treat these conditions.
Revive is actively pursuing a product and clinical development plan intending to unlock the full potential of bucillamine for infectious diseases. The company will continue to announce its initiatives as they unfold.
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 Food and Drug Administration such as orphan drug, fast track, breakthrough therapy and rare pediatric disease designations.
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