Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1) announced Tuesday that it has received positive feedback from Health Canada on its application for a clinical trial on ARDS-003 for coronavirus (COVID-19) patients.
In a statement, the Ottawa-based company said that Health Canada had acknowledged that the preclinical safety data are “robust and sufficient” to file a clinical trial application designed to treat hospitalized COVID-19 patients, who are at risk of developing ARDS, or acute respiratory distress syndrome.
Derived from cannabinoids, ARDS-003 is designed to prevent and treat the severe inflammatory response that could be life-threatening to coronavirus patients.
READ: Tetra Bio-Pharma initiates additional studies on lead drug candidate ARDS-003
Tetra Bio-Pharma told shareholders that its trial will be the first worldwide drug to involve the use of an injectable sterile synthetic cannabinoid in patients with COVID-19. The company is hoping to demonstrate the effectiveness of ARDS-003 in preventing acute respiratory distress in COVID patients.
The study is a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ascending doses of ARDS-003 in hospitalized COVID-19 patients with pneumonia and at risk of developing acute respiratory distress syndrome.
Tetra Bio-Pharma is now approved to file a clinical trial application in patients with COVID-19. The regulators also agreed on the proposed study design, target population, and primary and secondary objectives and endpoints, according to Tetra.
'Last missing step'
"Health Canada acknowledges the excellence of our preclinical data package,” Tetra CEO Guy Chamberland said in a statement Tuesday.
“Getting the green light from the authorities to administer this trial in patients was the last missing step for Tetra to initiate ARDS-003 clinical development in COVID-19 patients.”
The preliminary approval of the study protocol and prior review of the preclinical safety data will allow the company to quickly move through the Health Canada clinical trial application revision process, Chamberland told investors.
“This is extremely positive feedback for Tetra and its shareholders,” the CEO added. “Not only are we able to advance to COVID-19 patients, but we can leverage the approved preclinical safety data to investigate other indications with ARDS-003, such as sepsis.”
Tetra Bio-Pharma is a biopharmaceutical pioneer in immunomodulator drug discovery and development with a Food and Drug Administration (FDA) and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.
Contact Angela at angela@proactiveinvestors.com
Follow her on Twitter @AHarmantas