Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1) announced Monday that the US Food and Drug Administration (FDA) had positive things to say during a review of the preclinical data package and clinical development plan for its drug ARDS-003 as a treatment for the coronavirus (COVID-19).
The review was conducted within the framework of the Coronavirus Treatment Acceleration Program (CTAP), the FDA's expedited process for investigational therapies to treat COVID-19 patients, the company said. The regulatory body agreed that the animal toxicology and safety data indicates that ARDS-003 is safe for human use, and it approved the sample size, safety procedures and duration of treatment in severe COVID-19 patients.
Having received feedback, the company plans to file an investigational new drug application to initiate a clinical trial. The proposed patient study is a 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 who are at risk of developing acute respiratory distress syndrome, the company said.
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"I'm very pleased with the FDA feedback on our data package and clinical strategy,” CEO Guy Chamberland said in a statement. “Such feedback gives us a great insight on the authority's positive perception of our product and will facilitate the IND review process. I'm confident that we are now aligned with the authorities for the development plan of ARDS003."
ARDS-003 is formulated to treat hyperinflammatory conditions, such as those seen in patients suffering from COVID-19 viral infections, the company said. The investigational drug works by dampening a harmfully overactive immune response called cytokine release syndrome, which is often characterized by fever and organ dysfunction.
The plan is to administer ARDS-003 in combination with dexamethasone, an existing anti-inflammatory drug, also being used as a treatment for COVID-19.
ARDS (acute respiratory distress syndrome) is the leading cause of mortality in COVID-19 patients, the company said. It develops in between 20% and 67% of critically ill patients and 76% of patients requiring ICU care.
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