The life sciences company announced the news Friday, calling the FDA approval a “tremendous milestone” for the company.
Bucillamine could have the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive effects of COVID-19 infection in the lungs.
READ: Revive Therapeutics submits IND application to the FDA for potential coronavirus treatment Bucillamine
Revive submitted its investigational new drug application (IND) to the FDA for Bucillamine at the end of June.
“The FDA approval of the Phase 3 study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19 is a tremendous milestone for Revive and I am very proud of the dedication of our team and partners to bring forward a potential new treatment option for patients with a confirmed diagnosis of COVID-19 globally,” said Michael Frank, Revive’s CEO in a statement.
“We thank the FDA for recognizing the importance of this Phase 3 study and we are now focused on executing on our plans for initiating the clinical trial in an expeditious manner.”
The primary objective of Phase 3 is to compare frequency of hospitalization and mortality in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo.
Phase 3 will enroll up to 1,000 patients that will be randomized 1:1:1 to receive either 100 mg or 200 mg of Bucillamine three times a day or a placebo for up to 14 days.
An interim analysis will be performed by an Independent Data and Safety Monitoring Board (DSMB) after 210 patients have been treated and followed up for a total of 28 days after randomization, after which researchers will select the better performing Bucillamine dose. Patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint.
The DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports, according to Revive.
The firm cautioned shareholders that it is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 at this time.
The study is currently slated to begin in the third quarter of 2020.
Shares of Revive were up 32% in Canada at C$0.31 at the midday point on Friday.
--Updates with study details and share price--
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