공시 • Sep 18
Revive Therapeutics Ltd. Announces Strategic Focus on Bucillamine for Infectious Diseases and Medical Countermeasures
Revive Therapeutics Ltd. announced its strategic focus on dedicated its resources to advancing the clinical development of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties. The Company has decided not to pursue the development of the Long COVID diagnostic product. Any additional antioxidant effects on seizure activity and survival will also be assessed. The results from this research partnership, if promising, will determine further studies to facilitate FDA and Health Canada approvals for the use of Bucillamine in nerve agents or organophosphate pesticide poisoning. Also, the Company may explore the potential of Bucillamine for traumatic brain injury caused by concussive or exploration forces. The research study is progressing and is expected to be now completed in October 2024. The results from the DRDC research study, if promising, may determine further studies for the potential use of Bucillamine in various viral infections, including monkeypox ("Mpox"). In 2023, the World Health Organization released a Mpox fact sheet suggesting that severe cases of Mpox result in a number of conditions, including inflammation of the brain, heart, rectum, genital organs and urinary passages. A study in 2022 made the link between the administration of antioxidants and the improvement of virus-induced effects or to reduce viral replication yield. The suggestion that strong antioxidants such as N-acetyl-L-cysteine ("NAC"), butylated hydroxyanisole or Terameprocol could have an effect on Mpox viral infection in humans to ease severe symptoms. NAC has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant 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. Long COVID The CDC estimates that 7.5% of U.S. adults have long COVID symptoms. David Cutler, PhD, a professor of economics at Harvard University, estimates in a recent research disclosure that the total economic cost of long COVID could be as much as $3.7 trillion. Currently, the Company is exploring the use of Bucillamine as a potential treatment for long COVID by leveraging the published research and data from its previous Phase 3 clinical trial. Per the results of the Type C meeting written responses received by the Company from the U.S. Food & Drug Administration ("FDA") for the evaluation of a proposed clinical study of Bucillamine as a potentially treatment for Long COVID, the FDA has recommended that the evaluation of Bucillamine for Long COVID be submitted as a new Investigational New Drug ("IND") application and may cross-reference applicable sections from the Company's current IND, that evaluated the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19 in the Phase 3 clinical trial. In addition, the FDA provided valuable feedback on the appropriate design, study population, and safety and efficacy measures for assessing a therapeutic benefit in patients with Long COVID. The Company is finalizing the proposed Phase 2 study protocol for submission to the FDA. It expects to submit it by the end of 2024. The proposed Phase 2 clinical study is expected to be approved by the FDA in first quarter-2025. As a background, on July 6, 2023, the Company announced the results of its Study evaluating the safety and efficacy of Buc Drillamine in patients with mild tomoderate COVID-19. Under the Study's primary endpoint, the proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through Day 28 following randomization, there were no deaths and four hospitalizations, of which three were from time of first dose through day 28 following randomization, there was no deaths and four hospitalizations, of which three were from the placebo arm and one from the Bucillamine low dose group (300mg/day). No hospitalizations occurred in the Bucillamine large dose group (600mg/day). The Company evaluated certain Study endpoints, including the COVID-19 clinical symptoms data (i.e. cough, fever, heart rate, and oxygen saturation). Based on preliminary analyses, the data demonstrated that for patients with oxygen saturation <96% at baseline, Bucillamine had a 29.1% improvement over placebo in time to normal oxygen saturation (SpO2). Additional analyses of the Study data may suggest Bucillamine’s potential for long COVID.