Revive Therapeutics Moves Forward with Bucillamine for Potential Long COVID Treatment

Introduction to Revive Therapeutics’ Latest Advancements

Revive Therapeutics Ltd., a specialty life sciences company, has recently provided an update about the clinical study of Bucillamine, which they are researching as a potential treatment for Long COVID. Previously used in a Phase 3 clinical trial for mild to moderate COVID-19, Bucillamine has shown potential due to its anti-inflammatory and antiviral properties.

FDA Guidelines and Recommendations

The U.S. Food & Drug Administration (FDA) has advised Revive Therapeutics to submit a new Investigational New Drug (IND) application for Bucillamine's evaluation in Long COVID, referencing relevant data from the initial IND used for treating mild to moderate COVID-19. The FDA has also provided important feedback on study design, patient population, and safety and efficacy measures to assess therapeutic benefits in Long COVID patients.

Details of the Proposed Study

Revive plans to use the insights from the FDA to finalize their clinical study protocol and submit the new IND application. The previous Phase 3 trial for COVID-19 showed promising results, particularly in normalizing oxygen saturation levels in patients.

Another study has shown that thiol-based drugs, like Bucillamine, effectively reduce SARS-CoV-2 spike protein binding, virus entry, and live virus infection. This supports the rationale for testing Bucillamine in treating COVID-19 and potentially Long COVID.

Economic and Medical Impact of Long COVID

Long COVID has substantial social and economic impacts. The CDC approximates that 7.5% of U.S. adults experience Long COVID symptoms. Harvard economist David Cutler estimates that the economic burden of Long COVID in the United States could be as high as $3.7 trillion.

Revive’s Broader Mission

Revive Therapeutics focuses on developing treatments for infectious diseases, rare disorders, and medical countermeasures. They employ various strategies to speed up their drug development through FDA regulatory incentives.

Current Progress and Next Steps

The company is currently advancing the development of Bucillamine based on the results from their previous studies and regulatory meetings. Their goal is to compile a comprehensive regulatory and clinical package, incorporating the FDA’s recommendations from the Type C meeting.

On July 6, 2023, they announced the outcome of their Phase 3 clinical trial for Bucillamine in treating mild to moderate COVID-19. No deaths were reported, and hospitalizations were minimal, especially in patients using higher doses of Bucillamine.

Scientific Foundations for Bucillamine

Evidence suggests that thiol-based drugs, including Bucillamine, can block the binding of the SARS-CoV-2 spike protein to its receptor, reducing virus entry and infection rates. Such characteristics make Bucillamine a compelling candidate for further research.

About Revive Therapeutics

Revive Therapeutics Ltd. is a company focused on creating solutions for infectious diseases, medical emergencies, and rare disorders. They are also exploring Bucillamine for nerve agent exposure and Long COVID, as well as advancing Psilocybin-based therapeutics.

Conclusion

Revive Therapeutics is committed to finalizing the necessary clinical studies and receiving FDA approval to further research Bucillamine's potential in treating Long COVID. The company continues to leverage regulatory incentives to expedite their drug development processes.