Revive Therapeutics gets FDA approval to start Phase 3 of possible COVID-19 treatment Bucillamine
Revive Therapeutics Ltd (CSE:RVV) received US Food and Drug Administration approval to kick off its Phase 3 trial of its lead drug Bucillamine to treat patients with coronavirus (COVID-19).
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.
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.
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Story by ProactiveInvestors
Source: https://www.proactiveinvestors.com/companies/news/925605/revive-therapeutics-gets-fda-approval-to-start-phase-3-of-possible-covid-19-treatment-bucillamine-925605.html
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