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Revive submits meeting request to U.S. FDA

2024-03-27 13:25 ET - News Release

Mr. Michael Frank reports


Revive Therapeutics Ltd. has submitted a Type C meeting request package to the United States Food and 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 per cent of U.S. adults have long COVID symptoms. 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.

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 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 end point 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 (300 milligrams per day). No hospitalizations occurred in the bucillamine large dose group (600 milligrams per day). The company evaluated certain study end points, including the COVID-19 clinical symptoms data (cough, fever, heart rate and oxygen saturation). Based on preliminary analyses, the data demonstrated that for patients with oxygen saturation less than 96 per cent at baseline, bucillamine had a 29.1-per-cent 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.

We seek Safe Harbor.

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