Biotech
Thursday, March 28th, 2024 2:20 am EDT
Key Points
- Revive Therapeutics Ltd. has submitted a Type C meeting request package to the U.S. Food & Drug Administration (FDA) for the evaluation of a proposed clinical study of Bucillamine as a potential treatment for long-term COVID.
- The Company is exploring the use of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, for the treatment of long COVID, aiming to leverage previous Phase 3 clinical trial data and research findings.
- Preliminary data from a previous study evaluating Bucillamine in patients with mild to moderate COVID-19 suggests its potential for long COVID treatment. Additionally, research indicates thiol-based drugs like Bucillamine may inhibit SARS-CoV-2 cell entry, providing a rationale for testing them as COVID-19 treatments.
TORONTO, March 27, 2024 (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 medical needs and rare disorders, announced today that it has submitted a Type C meeting request package to the U.S. Food & Drug Administration (“FDA”) for the evaluation of a proposed clinical study of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for long-term COVID. Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.
The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms1. 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 trillion2.
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 (the “Study”) and is finalizing the regulatory and clinical package that includes a proposed clinical study for long COVID to present to the FDA.
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.
About Revive Therapeutics Ltd.
Revive Therapeutics is a life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders. 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.
For more information, please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: 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.
