Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) has submitted its Investigational New Drug (IND) application to the US Food and Drug Administration for its Phase 3 study of potential coronavirus treatment Bucillamine, it said Tuesday.
The Toronto-based company believes Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive effects of COVID-19 infection in the lungs.
Once approval is received, Toronto-based Revive will begin a randomized, double-blind and placebo-controlled study of Bucillamine on patients with mild to moderate COVID-19 symptoms. The study is currently slated to begin in the third quarter of 2020.
READ: Revive Therapeutics holds pre-CTA meeting with Health Canada for Bucillamine to treat COVID-19 patients
“We are very pleased in achieving this major milestone of filing our IND for a Phase 3 confirmatory study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19, which was based on the recommendation from the US FDA from our pre-IND meeting earlier this year,” Michael Frank, Revive’s CEO said in a statement.
Bucillamine has a strong clinical history as a treatment for rheumatoid arthritis. Since Revive conducted a Phase 2 trial for gout in the past, it has strong supporting documentation for the FDA for a potential Phase 3 study.
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.
The Phase 3 study will be a multicenter, randomized, double-blind, placebo-controlled study of Bucillamine, or placebo in patients with mild-to-moderate COVID-19. Symptomatic patients will initially be randomized 1:1:1 to receive Bucillamine 300 mg/day, Bucillamine 600 mg/day, or a placebo.
“We are preparing plans for initiating the Phase 3 study upon the IND becoming active by the US FDA and we look forward to advancing Bucillamine as a potential new treatment option for patients with a confirmed diagnosis of COVID-19 globally.”
Revive recently held a Pre-Clinical Trial Application meeting with Health Canada to evaluate the potential of a clinical study of Bucillamine in Canada.
Shares of Revive jumped 13.7% higher to close at C$0.29 in Canada and 11.8% over the counter at US$0.21.
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