In a news release, Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS) announced that "following the U.S. Food and Drug Administration (FDA) approval to proceed with its Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19, the company has submitted its clinical trial protocol for independent Institutional Review Board (IRB) approval."
The firm indicated also that it is currently exploring the FDA Expanded Access Program, more commonly known as the Compassionate Use Program, that can serve to provide access to Revive Therapeutics' investigational drug Bucillamine for individuals who meet the protocol requirements of the COVID-19 study. The company stated that it expects to have patients enrolled in September 2020.
The company's CEO Michael Frank stated, "We are continuing to make strong progress in our Phase 3 clinical trial in COVID-19 and with the submission of the Phase 3 study protocol to Advarra, a premier IRB services company in North America, for review and approval, it will enable us to select key clinical sites in the U.S. and proceed with site initiation visits to allow for the selected U.S. clinical locations to enroll patients...We are also exploring the Compassionate Use Program as an alternate option for U.S. licensed physicians to request Bucillamine for their patients who have been diagnosed with COVID-19."
Revive stated that the FDA's expanded access programs offer patients the opportunity to be treated with an investigational drug for a serious condition or disease when there are no existing alternative therapies. This often occurs when patient enrollment in clinical studies is not feasible, but the potential benefit to patients outweighs the potential risk of treatment.
The company reported that it plans to enroll up to 1,000 patients in its Phase 3 randomized, multi-center confirmatory clinical study of Bucillamine in Patients with Mild-Moderate COVID-19. Patients in the trial will be randomized to receive either 100 mg or 200 mg of Bucillamine or placebo three times daily for 14 days. The firm advised that the study's primary goal 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 indicated 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 time, the dosage level demonstrating the best results will be selected and randomized at a ratio of 2:1 versus placebo. The DSMB will closely follow the data and will perform additional interim analyses after 400, 600 and 800 patients have reached the same post-treatment time frame.
The firm pointed out that Bucillamine has a well-known safety profile and has been prescribed for treating rheumatoid arthritis in Japan and South Korea for more than 30 years.
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