Revive Therapeutics Ltd broadens Phase 3 coronavirus trial of Bucillamine to Asia-Pacific and Canada

Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) is growing its Phase 3 trial of Bucillamine in patients with mild-to-moderate COVID-19 after receiving approval from the US Food and Drug Administration, the company announced on Wednesday.

The company plans to expand the trial in Asia-Pacific Countries (APAC) and Canada, on top of its operations in the US. The plan is to enroll as many as 1,000 patients that will be randomized 1:1:1 to receive 100 milligrams (mg) of Bucillamine, 200 mg or a placebo three times a day for up to 14 days, in order to evaluate the safety and efficacy of the drug.

The primary endpoint is the rate of hospitalization and death, the company said.

READ: Revive Therapeutics inks memorandum with Atwill Medical to support its coronavirus clinical trial of Bucillamine

“With the approval from the FDA to conduct the Phase 3 clinical trial in COVID-19 and our progress that we have made to date, we are now establishing plans to complement and support our initiatives in the US to include clinical sites in APAC and Canada,” CEO Michael Frank said in a statement.

Revive said it expects to open the trial for enrollment and dosing in September. The company and its partners are evaluating possible clinical sites and investigators in the US, APAC and Canada to complement sites in California, Florida, Arizona, and Texas.   .

An interim analysis will be conducted after 210 patients have been treated and followed up for a total of four weeks after the randomization. 

The company stressed it is not making any express or implied claims that its product has the ability to eliminate or cure the coronavirus at this time.

Contact Andrew Kessel at [email protected]

Follow him on Twitter @andrew_kessel

Story by ProactiveInvestors