TORONTO, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for infectious diseases and medical countermeasures, announced today an update on its research and development focus on Bucillamine.
Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, 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 N-Acetyl-L-Cysteine (“NAC”).1
The Company will be focusing on the following programs with Bucillamine:
Medical Countermeasures
Revive is targeting nerve agent exposure as its initial indication for its medical countermeasures program. Nerve agents are chemicals that affect the nervous system. Nerve agents are highly toxic regardless of the route of exposure. The main chemical nerve agents that are man-made and manufactured for use in chemical warfare are sarin, soman, tabun and VX. These nerve agents are known to be present in military stockpiles. Exposure to nerve agents can occur due to chemical warfare or accidental release from a military storage facility. Exposure to nerve agents can cause tightness of the chest, excessive salivation, abdominal cramps, diarrhea, blurred vision, tremors, and death.
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 NAC 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(A) receptors, which are required for the effectiveness of currently fielded anticonvulsant therapies. Bucillamine and NAC will be evaluated to determine the effect on GABA(A) 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, and for concussion.
The research study is progressing and is expected to be now completed in February 2025.
Infectious Diseases
Revive is targeting Long COVID as its initial indication for its infectious disease program. The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms.2 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.3
As a background, on July 6, 2023, the Company announced the results of its Study evaluating the safety and efficacy of oral Bucillamine in patients with mild to moderate 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 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.
A study titled “Thiol-based drugs decrease binding of SARS-CoV-2 spike protein to its receptor and inhibit SARS-CoV-2 cell entry” showed that thiol-based drugs, like Bucillamine, decrease the binding of SARS-CoV-2 spike protein to its receptor, decrease the entry efficiency of SARS-CoV-2 spike pseudotyped virus, and inhibit SARS-CoV-2 live virus infection. These findings uncovered a vulnerability of SARS-CoV-2 to thiol-based drugs and provided a rationale to test thiol-based drugs such as Bucillamine as novel treatments for COVID-19.
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 potential 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 continues to finalize the proposed Phase 2 study protocol for submission to the FDA. It expects to submit it by the end of Q1-2025. The proposed Phase 2 clinical study is expected to be approved by the FDA in Q2-2025.
The Company would like to make it clear that it is not making any express or implied claims that its product (Bucillamine) has the ability to treat, eliminate or cure long COVID, and/or other infectious diseases and medical countermeasures indications at this time.
The Company also announces that in connection with an award issued by the ICC International Court of Arbitration on May 28, 2024, Revive has agreed to a consent judgement in the Ontario Superior Court with one of its service providers. The consent judgment recognizes the award in the amount of Euro $301,806.5, USD$160,800,00, and pre-judgment interest costs. In connection with the consent judgment, Revive’s service provider will take no steps to enforce the consent judgment until May 22, 2025. Revive is planning to settle the arbitration award.
About Revive Therapeutics Ltd.
Revive Therapeutics is a life sciences company focused on the research and development of therapeutics for infectious diseases and medical countermeasures. Revive prioritizes its drug development efforts to take advantage of several regulatory incentives awarded by the FDA, such as Emergency Use Authorization, Orphan Drug, Fast Track, and Breakthrough Therapy designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of nerve agent exposure and long COVID. Revive is also advancing the development of Psilocybin-based therapeutics through various programs. For more information, visit www.ReviveThera.com.
Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “may”, “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company's management's discussion and analysis for the three months ended September 30, 2024 ("MD&A"), dated November 29, 2024, which is available on the Company's profile at www.sedarplus.ca.
“The Economic Cost of Long COVID: An Update,” David M. Cutler, Harvard University, July 22, 2022, https://scholar.harvard.edu/files/cutler/files/long_covid_update_7-22.pdf
