Revive Therapeutics offers update on research, clinical, regulatory initiatives

Revive Therapeutics announced a corporate update on the research, clinical and regulatory initiatives with Bucillamine and its long COVID diagnostic product. The Company is advancing the research and development of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for long COVID and medical countermeasures, such as nerve agent exposure. Chemical Warfare – Nerve Agent Exposure: Currently, in partnership with Defence R&D Canada – Suffield Research Centre, an agency of the Canadian Department of National Defence, the Company is evaluating Bucillamine as a potential treatment for nerve agent exposure. DRDC is investigating pharmacological compounds that can mitigate nerve agent induced brain injury. Recent studies have shown that antioxidant compounds such as n-acetylcysteine could be beneficial in limiting seizure activity and improving the anticonvulsant efficacy of GABA-mediating drugs such as diazepam. Bucillamine is a significantly more effective antioxidant than NAC and has the potential to provide increased efficacy against seizure activity while limiting the anticoagulant and bleeding event liability observed with NAC. The overall objective of the research project is to investigate pharmacological means for neuroprotection of GABA receptors, which are required for the effectiveness of currently fielded anticonvulsant therapies. Bucillamine and NAC will be evaluated to determine the effect on GABA receptor endocytosis and the effect on diazepam effectiveness in terminating seizures. 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 explosive forces. The research project is expected to be completed by June 2024. Long COVID: Currently, the Company is exploring the use of Bucillamine as a potential treatment for long COVID. The Company is advancing the clinical development of Bucillamine by leveraging the published research and data from its previous Phase 3 clinical trial in preparing a regulatory and clinical package that includes a proposed Phase 2 clinical study for long COVID to present to the FDA and international health regulatory authorities. The Phase 2 study protocol has been completed, and the Company is preparing its submission to the FDA. It expects to submit it by the end of March 2024. The proposed Phase 2 clinical study is expected to be approved by the FDA in Q2-2024. In addition, Revive may evaluate the potential of its proposed long COVID diagnostic product as a companion to Bucillamine. Long COVID Diagnostic Product: The Company, under its wholly-owned subsidiary Revive Diagnostics Inc., is advancing the product development of a potential blood biomarker diagnostic that characterizes long COVID. The discovery of the biomarkers identified by a research team at Lawson, led by Dr. Douglas Fraser, was recently published in the journal, Molecular Medicine. The Company entered into a license agreement with Lawson Health Research Institute for the worldwide exclusive rights to the intellectual property of novel blood biomarkers that characterize long COVID. The intellectual property includes PCT/CA2023/050145 entitled “Blood Biomarkers in Long-COVID19”; PCT/CA2023/051292 entitled “Biomarkers in Long-COVID19”; and US Provisional Patent Application No. 63/433,425 entitled “Diagnosis and Treatment of Long-COVID”. Revive and Lawson continues to work together in completing the product development and investigational plans of a qELISA laboratory test kit and a point-of-care device for rapid testing of long COVID for FDA review, feedback and acceptability. The Company expects to submit a pre-investigational device exemption meeting package with the FDA in April 2024 and have its meeting with the FDA in early Q3-2024.