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Revive Therapeutics has submitted a clinical trial application to Health Canada to conduct a Phase III clinical trial of Bucillamine to treat patients with mild to moderate Covid-19.
The company expects to have a meeting with Health Canada this week, with plans to discuss Bucillamine chemistry, manufacturing non-clinical and clinical safety and clinical trial design.
Revive also expects guidance from the regulatory authority on potentially adding an exploratory arm in the proposed trial for a subset of the pediatric population.
If Health Canada approves the application, the company plans to begin the trial as soon as possible.
Meanwhile, Revive is also finalising its investigational new drug (IND) application with the US Food and Drug Administration (FDA) for the proposed Phase III trial of Bucillamine in patients with mild to moderate Covid-19.
The company intends to submit the IND later this month.
Revive Therapeutics CEO Michael Frank said: “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 III confirmatory study to be conducted in the US and our expansion into Canada.”
The adaptive, multi-centre, randomised, double-blind, placebo-controlled Phase III trial will compare the drug to placebo in a minimum of 210 participants.
The primary objective of the trial is frequency of hospitalisation and mortality while secondary objectives include safety, disease course, time to clinical improvement, and impact on supplemental oxygen needs.
Furthermore, the trial will monitor an exploratory objective of the effects on viral clearance from nasal swabs in Covid-19 patients.