Mr. Michael Frank reports

REVIVE THERAPEUTICS EXPLORES THE USE OF BUCILLAMINE FOR LONG COVID

Revive Therapeutics Ltd. aims to advance the clinical development of bucillamine as a potential treatment for long COVID by leveraging the published research and existing data from its previous phase 3 clinical trial, and is preparing a clinical package that includes a proposed phase 2/3 clinical protocol for long COVID to present to the FDA (Food and Drug Administration) and international health regulatory bodies. Bucillamine is an oral thiol-based drug with anti-inflammatory and anti-viral properties.

The CDC (Centers for Disease Control and Prevention) estimates that 7.5 per cent of United States 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.

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 end point, 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 (mg)/day). No hospitalizations occurred in the bucillamine large-dose group (600 mg/day). The company also evaluated certain study end points, including the COVID-19 clinical symptoms data (that is, 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).

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 a novel treatment for COVID-19.

About Revive Therapeutics Ltd.

Revive Therapeutics is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing 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 public health medical emergencies and rare inflammatory disorders. Revive is also advancing the development of psilocybin-based therapeutics through various programs.

We seek Safe Harbor.