Revive Therapeutics Ltd. is sharpening its R&D focus on Bucillamine, an oral thiol-based drug, for both infectious diseases and as a medical countermeasure against nerve agent exposure. The company is leveraging Bucillamine's anti-inflammatory and antiviral properties, along with its established safety profile from over 30 years of use in Japan and South Korea for rheumatoid arthritis.
Medical Countermeasures Program
Revive is initially targeting nerve agent exposure within its medical countermeasures program. Nerve agents, including sarin, soman, tabun, and VX, pose a significant threat due to their high toxicity and presence in military stockpiles. Exposure can lead to severe symptoms, including chest tightness, salivation, seizures, and potentially death.
In collaboration with Defence R&D Canada – Suffield Research Centre (DRDC), Revive is assessing Bucillamine's potential to mitigate nerve agent-induced brain injury. DRDC's research indicates that antioxidant compounds like N-Acetyl-L-Cysteine (NAC) may limit seizure activity and improve the efficacy of GABA-mediating drugs like diazepam. Bucillamine, being a more potent antioxidant than NAC, could offer enhanced efficacy against seizures while reducing the risk of anticoagulant and bleeding events associated with NAC.
The research project aims to investigate pharmacological approaches for neuroprotection of GABA(A) receptors, crucial for the effectiveness of current anticonvulsant therapies. Bucillamine and NAC will be compared for their effects on GABA(A) receptor endocytosis and diazepam's effectiveness in terminating seizures. The study is expected to be completed in February 2025, with promising results potentially leading to further studies for FDA and Health Canada approvals for Bucillamine's use in nerve agent or organophosphate pesticide poisoning.
Infectious Diseases Program
Revive is also pursuing Bucillamine as a potential treatment for Long COVID. The CDC estimates that 7.5% of U.S. adults experience Long COVID symptoms, with some economists estimating the total economic cost could reach $3.7 trillion.
Data from a previous Phase 3 trial evaluating Bucillamine in mild to moderate COVID-19 patients showed that in patients with oxygen saturation <96% at baseline, Bucillamine had a 29.1% improvement over placebo in time to normal oxygen saturation (SpO2). Further analysis of this data may support Bucillamine's potential in treating Long COVID.
Based on feedback from the FDA, Revive is preparing to submit a new Investigational New Drug (IND) application for a Phase 2 study evaluating Bucillamine in Long COVID patients. The FDA has provided guidance on study design, patient population, and safety and efficacy measures. The company anticipates submitting the Phase 2 study protocol by the end of Q1 2025, with potential FDA approval in Q2 2025.
