TBPMF - Health Canada gives green light to Tetra Bio's ARDS-003 trial in COVID-19

Tetra Bio-Pharma (TBPMF) announces that Health Canada supports the filing of a Clinical Trial Application ((CTA)) for assessing their novel drug candidate, ARDS-003, in patients with COVID-19. Tetra's trial will be the first worldwide drug which involves the use of an injectable sterile synthetic cannabinoid in patients infected by COVID-19. The proposed study will 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. Health Canada acknowledged that Tetra's extensive nonclinical data meet the authority's requirements for a New Molecular Entity and granted the Company the approval for filing a CTA.The authorities also agreed on the proposed study design, target population, and primary and secondary objectives and endpoints of the study in severe COVID-19 patients. The investigational drug is designed to dampen the cytokine release syndrome and will be administered in combination with

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Health Canada gives green light to Tetra Bio's ARDS-003 trial in COVID-19