PATHWAY NOW CLEARED FOR HUMAN TRIALS
OTTAWA, ON / ACCESSWIRE / December 2, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today announced it has completed Investigational New Drug (IND) -enabling toxicology, clearing the way for human clinical trials for its novel drug candidate ARDS-003.
Acute Respiratory Distress Syndrome (ARDS) is a leading cause of death in patients with COVID-19, as well as in other conditions that cause severe respiratory inflammation. Tetra Bio-Pharma's novel drug candidate ARDS-003, is a synthetic cannabinoid-derived therapeutic aimed at preventing and treating the serious and life-threatening inflammatory response that is associated with COVID-19, sepsis, septic shock, and others.
Successful completion of the safety studies is required to submit a Clinical Trial Application in Canada and an IND in the USA for ARDS-003 for a Phase I study in humans. Dr. Guy Chamberland M.Sc., Ph.D., Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma noted, "This is 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. Based on the safety data, the medicinal ingredient and the sterile injectable drug product ARDS-003 are both safe for use in humans. With over 12 years of preclinical efficacy research in sepsis and cytokine hyperinflammatory reactions, we are very confident that ARDS-003 will be an efficacious drug. Moreover, this will allow us to address markets with large unmet medical needs in conditions where uncontrolled inflammatory response contributes to mortality."
The toxicology program was designed to meet the international standards established by the International Council for Harmonisation (ICH) for enabling a first-in-human clinical trial and included general toxicology in two species, specific studies to assess toxicity in major organ systems (cardiovascular, respiratory, nervous system) and genotoxicity. Studies investigating the metabolism and kinetics of distribution were also completed.
The toxicology studies were performed in rodent and nonrodent species and include:
- single dose pharmacokinetics;
- maximum tolerated dose;
- 7-day dose range finding; and
- 14-day repeat dose toxicity with toxicokinetics and recovery.
Safety pharmacology and other toxicology studies include:
- cardiovascular study in conscious dogs;
- respiratory system assessment in rodent; and
- central nervous system assessment in rodent.
Genotoxicity assessments include:
- bacterial reverse mutation assay
- in vitro (mammalian cell) micronucleus assay
- in vivo micronucleus assay
- Metabolic profiling;
- cytochrome P450 inhibition and induction;
- microsome and hepatocyte stability (mouse, rat, dog, monkey, human); and
- blood compatibility.
The Company is not making any expressed or implied claims that its product has the ability to eliminate, cure and/or contain the COVID-19 or the SARS-COV-2 virus at this time.
About ICH
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