Revive Therapeutics commits to 10 sites for Phase 3 coronavirus trial of bucillamine
Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) announced Monday that it has committed to 10 clinical sites in the US for its Phase 3 trial of bucillamine in mild-to-moderate cases of the coronavirus and expects more than 200 patients to complete the study by the end of the year.
The study is testing two dosage levels of bucillamine, and an interim analysis of the initial patients will determine the better performing bucillamine dose arm for the remainder of the trial and future complementary studies of more severe cases.
"We are one of a few life sciences companies evaluating an investigational drug in a Phase 3 clinical trial for COVID-19 and with the rising prevalence of cases throughout the US, we are confident that our targets will be achieved to support the potential FDA approval and commercialization of bucillamine for the treatment of the virus," CEO Michael Frank said in a statement.
The trial, titled, "A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19", will enroll as many as 1,000 patients that will be randomized 1:1:1 to receive bucillamine 100 mg three times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days.
The company also pointed to the recent publication of research in the October 2020 issue of Clinical Immunology highlighting the potential of N-acetyl-cysteine (NAC) in the treatment of COVID-19. NAC has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione. Revive said the research serves as further validation for bucillamine as a potential COVID-19 treatment.
Bucillamine, with its well-established safety record in more than 30 years of use in the treatment of rheumatoid arthritis, has been shown to be 16 times more potent as a thiol donor in vivo than NAC. Bucillamine also has the potential to lessen the destructive consequences of more advanced SARS-CoV-2 infections, the company said.
The company added that it is not making any express or implied claims that its product has the ability to eliminate or cure the coronavirus at this time.