In a news release, Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS) provided an update on its U.S. Food & Drug Administration (FDA) approved Phase 3 clinical study of Bucillamine in patients with mild-moderate COVID-19. The company indicated that it plans to conduct the trial at 10 locations across five U.S. states.
The firm projects that more than 200 patients will finish the trial by the end of December of this year. The company stated that the results obtained will be complied and reviewed in the interim analysis that will be instrumental in selecting the best performing Bucillamine dose arm for the remainder of the trial as well as for future expanded studies in much more severe COVID-19 cases.
The company's CEO Michael Frank commented, "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 U.S., 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."
The firm noted that a recent publication indicated that N-acetyl-cysteine (NAC) demonstrated some potential in COVID-19 treatment. The company stated that Bucillamine has a well-established 30-year safety record in use in rheumatoid arthritis treatment and has been has been shown to be 16 times more potent as a thiol donor in vivo than NAC.
The company stated it plans to enroll up to 1,000 patients in total in its Phase 3 multi-center double-blind clinical trial of Bucillamine in patients with mild to moderate COVID-19. Patients in the study will be randomized to receive either 100 mg or 200 mg of Bucillamine or placebo three times per day for 14 days. The firm advised that the study's primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy versus those receiving a placebo.
The company advised that an independent data and safety monitoring board (DSMB) will perform an interim analysis after 210 patients have been treated and followed up for 28 days after randomization. After that period, the dosage level which demonstrated the best results will be chosen and randomized at a 2:1 ratio versus placebo. The DSMB will closely monitor the data and will perform additional interim analyses after 400, 600, and 800 patients complete their respective 28-day treatments. The firm mentioned that it now projects that the first round of over 200 patients will complete the study prior to the end of December 2020.
Revive Therapeutics stated that it is not making claims of any kind that its product has the ability to cure or eliminate COVID-19 (SARS-2 Coronavirus) at this time.
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