Revive Therapeutics Updates on FDA Type C Meeting for Bucillamine Long COVID Study

Revive Therapeutics Ltd., a life sciences company specializing in the development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders, announced an update regarding its proposed clinical study for Bucillamine as a potential treatment for Long COVID. The announcement comes after receiving written responses from the U.S. Food & Drug Administration (FDA) on the planned study.

The FDA has recommended that the evaluation of Bucillamine for Long COVID be submitted as a new Investigational New Drug (IND) application. This new IND can reference sections from Revive’s existing IND, which evaluated the safety and efficacy of Bucillamine in a Phase 3 clinical trial for patients with mild to moderate COVID-19. Additionally, the FDA provided essential feedback on the appropriate design, study population, and safety and efficacy measures for the proposed study.

Michael Frank, CEO of Revive, expressed satisfaction with the FDA's feedback, stating that it provides a clear pathway for the clinical development of Bucillamine as a potential treatment for Long COVID. Frank added that the company plans to finalize the clinical study protocol and submit a new IND to obtain FDA approval for proceeding with the clinical trial.

Long COVID affects a significant portion of the population, with the CDC estimating that 7.5% of U.S. adults experience its symptoms. David Cutler, a professor of economics at Harvard University, estimated the total economic cost of Long COVID to be as high as $3.7 trillion.

Revive is currently advancing the clinical development of Bucillamine by leveraging data from its previous Phase 3 clinical trial. The company aims to complete the regulatory and clinical package for the proposed study, incorporating the FDA’s recommendations from the Type C meeting.

On July 6, 2023, Revive announced the results of their Phase 3 clinical trial that evaluated the safety and efficacy of oral Bucillamine in patients with mild to moderate COVID-19. The primary endpoint of the trial was to measure the proportion of patients experiencing hospitalization or death within 28 days following randomization. The results were promising; no deaths occurred, and of the four hospitalizations, three were from the placebo group and one from the low-dose Bucillamine group (300mg/day). Notably, no hospitalizations were reported in the high-dose Bucillamine group (600mg/day).

Additional analyses of the trial data indicated Bucillamine’s potential benefits. For instance, in patients with an initial oxygen saturation below 96%, Bucillamine showed a 29.1% improvement over placebo in time to restore normal oxygen levels. These findings suggest that Bucillamine may be effective in treating Long COVID.

A related study, “Thiol-based drugs decrease binding of SARS-CoV-2 spike protein to its receptor and inhibit SARS-CoV-2 cell entry,” demonstrated that thiol-based drugs, including Bucillamine, reduced the binding efficiency of the SARS-CoV-2 spike protein to its receptor and inhibited the virus's entry into cells. These results highlight the potential for thiol-based drugs as treatments for COVID-19.

Revive Therapeutics Ltd. is dedicated to developing innovative therapeutics and diagnostics for various medical conditions. The company focuses on leveraging regulatory incentives from the FDA, such as Emergency Use Authorization, Orphan Drug, Fast Track, and Breakthrough Therapy designations. Besides exploring Bucillamine’s potential for treating Long COVID, Revive is also working on developing Psilocybin-based therapeutics through various programs.