Revive Therapeutics Ltd (CNSX:RVV) (OTCMKTS:RVVTF) said Wednesday that it has filed its clinical trial application (pre-CTA) with Health Canada to open discussions on using its long-established rheumatoid arthritis treatment Bucillamine to treat coronavirus (COVID-19) patients.
The Toronto-based specialty life sciences company said it will have its Pre-CTA meeting with Health Canada this week. Revive said a complete briefing package detailing Bucillamine’s chemistry, manufacturing, non-clinical and clinical safety information, and clinical trial design accompanied the meeting request.
“The company expects to initiate a clinical study as soon as possible following receipt of regulatory clearance from Health Canada,” the company said in a statement.
Investors responded well, sending Revive Therapeutics stock up 8.5% in Canada and 11.7% to $0.24 in the OTC Markets.
Additionally, Revive Therapeutics is finalizing its Investigational New Drug (IND) package for the US Food and Drug Administration for the proposed Phase 3 confirmatory clinical trial to evaluate Bucillamine in the treatment of patients with mild-to-moderate COVID-19 due to the SARS-CoV-2 infection.
Revive said it will file the IND later this month and expects “final approval to proceed to the Phase 3 study shortly thereafter.”
“We are very pleased with the progress that has been made with our clinical strategy for Bucillamine in the potential treatment of COVID-19, specifically with our focus on a Phase 3 confirmatory study to be conducted in the US and our expansion into Canada,” Revive Therapeutics CEO Michael Frank said in a statement.
Phase 3 study design
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.
The company said symptomatic patients will initially be randomized 1:1:1 to receive Bucillamine 300 mg/day, Bucillamine 600 mg/day, or a placebo.
“The Phase 3 study will enroll a minimum of 210 patients, then a single Bucillamine dose is selected and a go/no-go decision is made,” said the company.
Patients will then be randomized 2:1 to receive the selected Bucillamine dose and placebo. Interim analyses will occur every 100 subjects up to the maximum sample size of 800 people. An independent data safety monitoring board will actively monitor interim data for the safety of the patients.
Revive said the primary objective of the Phase 3 study is to “compare the frequency of hospitalization and mortality” in patients with mild-to-moderate COVID-19 receiving Bucillamine therapy with those receiving a placebo.
“The primary endpoint is a 3-level ordinal scale of a patient’s worst outcome between randomization and day 28,” noted the company. The outcome is linked to death, being alive and hospitalized, and being alive and not hospitalized any longer.
The study’s secondary objectives will evaluate the safety of Bucillamine therapy administered at a low 300 mg a day dosage, and high 600 mg a dose for up to 14 days.
Interestingly, Revive Therapeutics originally re-purposed its long-established rheumatoid arthritis treatment Bucillamine as a drug for gout and did a FDA phase 2 study in the US. Now it is planning to submit it as a possible treatment for people suffering from lung inflammation from contracting COVID-19.
Revive is a life sciences company focused on research and development of drugs for infectious diseases and rare disorders. With its recent acquisition of Psilocin Pharma, Revive is also advancing the development of psilocybin-based therapeutics.
Contact the author Uttara Choudhury at email@example.com
Follow her on Twitter: @UttaraProactive