- The FDA has favorably reviewed the preclinical data package and clinical development plan of Tetra Bio-Pharma's (OTCQB:TBPMF) ARDS-003 to treat COVID-19.
- The Agency agreed with the animal toxicology and safety data to ensure that ARDS-003 is safe for human use, and approved the sample size, safety procedures and duration of treatment in severe COVID-19 patients.
- As a result of this feedback, the Company looks forward to filing an Investigational New Drug Application to initiate the clinical trial.
- 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.
- Last month, Health Canada provided green light to Tetra Bio's ARDS-003 trial in COVID-19.