Biotech
Wednesday, June 12th, 2024 2:27 pm EDT
Key Points
- FDA Feedback on Bucillamine for Long COVID: The FDA has provided recommendations for evaluating Bucillamine as a potential treatment for Long COVID, suggesting a new Investigational New Drug (IND) application and offering guidance on study design, population, and safety measures.
- Positive Phase 3 Trial Results for Bucillamine: Previous Phase 3 trial results showed Bucillamine’s safety and efficacy in patients with mild to moderate COVID-19, with no hospitalizations in the high-dose group and improved oxygen saturation in certain patients.
- Economic Impact and Development Plans: With significant economic costs associated with Long COVID, Revive Therapeutics is advancing the clinical development of Bucillamine, incorporating FDA recommendations, and aims to finalize and submit the new IND to proceed with clinical trials.
TORONTO, June 12, 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 and diagnostics for infectious diseases, medical countermeasures, and rare disorders, announced today an update on the Type C meeting written responses received by the Company from 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 COVID (the “Study”).
The FDA has recommended that the evaluation of Bucillamine for Long COVID be submitted as a new Investigational New Drug (“IND”) application and may cross-reference applicable sections from the Company’s current IND that evaluated the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19 in a Phase 3 clinical trial. In addition, the FDA provided valuable feedback on the appropriate design, study population, and safety and efficacy measures for assessing a therapeutic benefit in patients with Long COVID.
“We are pleased with the FDA’s recommendations for our proposed clinical study, which provides a pathway for the clinical development of Bucillamine as a potential treatment for Long COVID,” said Michael Frank, CEO of Revive. “We aim to finalize the clinical study protocol and submit a new IND, which will cross reference our current IND to obtain FDA approval to proceed with the clinical trial for Long COVID.”
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 and aims to complete the regulatory and clinical package that includes a proposed clinical study for Long COVID, incorporating the recommendations from the FDA from the Type C meeting.
On July 6, 2023, the Company announced the results of its Phase 3 clinical trial evaluating the safety and efficacy of oral Bucillamine in patients with mild to moderate COVID-19. Under the Phase 3 clinical trial 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 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 Phase 3 clinical trial data analyses 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.comNeither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release
