Derived from cannabinoids, ARDS-003 is designed to prevent and treat acute respiratory distress syndrome (ARDS), a severe inflammatory response that could be life-threatening to patients with coronavirus (COVID-19) or sepsis.
Tetra’s program included general toxicology studies in two species as well as specific studies to assess toxicity in major organ systems as well as genotoxicity.
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The toxicology studies included single dose pharmacokinetics, maximum tolerated dosages, seven-day dose range finding and 14-day repeat dose toxicity with toxicokintetics and recovery in rodent and non-rodent species.
Safety pharmacology and other toxicology studies include cardiovascular study in conscious dogs as well as respiratory and central nervous system assessment in rodents.
The safety studies were necessary to submit a clinical trial application in Canada and an investigational new drug (IND) application in the US for a Phase I study in humans.
Tetra’s CEO Guy Chamberland called the news “an exciting and critical step” in the development of ARDS-003.
“As few as 1 out of 1,000 compounds cross this threshold and make it into Phase 1 human trials,” Chamberland noted in a statement. “Based on the safety data, the medicinal ingredient and the sterile injectable drug product ARDS-003 are both safe for use in humans.”
Chamberland said that the Ottawa-based firm was confident that ARDS-003 will be effective, given 12 years of preclinical efficacy research in sepsis and cytokine hyperinflammatory reactions.
He added: “(This) will allow us to address markets with large unmet medical needs in conditions where uncontrolled inflammatory response contributes to mortality."
Tetra estimates potential revenues from royalties on net sales, milestone and upfront payments of over US$500 million by 2026, based on a conservative market penetration and patient-based model.
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