08:01 AM EDT, 03/12/2024 (MT Newswires) -- Revive Therapeutics Ltd. ( RVVTF ) , a specialty life sciences company focused on the R&D of therapeutics for medical needs and rare disorders, on Tuesday provided a corporate update on the research, clinical and regulatory initiatives with Bucillamine and its long COVID diagnostic product.
Bucillamine
Currently, in partnership with Defence R&D Canada - Suffield Research Centre (DRDC), 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 (NAC) could be beneficial in limiting seizure activity and improving the anticonvulsant efficacy of GABA-mediating drugs such as diazepam.
The results from this research partnership will determine further studies to facilitate FDA and Health Canada approvals for the use of Bucillamine in nerve agents or organophosphate pesticide poisoning. The company may also 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.
Long COVID
Revive is exploring the use of Bucillamine as a potential treatment for long COVID. Revive is 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 Revive is preparing its submission to the FDA by the end of March. 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's 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 Health Research, 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. Revive and Lawson are working to complete 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 and have its meeting with the FDA in early Q3-2024.