One such company is Canada-based Tetra Bio-Pharma.
They’re utilizing scientific data and FDA-approved research to create cannabinoid-extracted medicine to aid with chronic pain, inflammation, oncology (cancer treatment), and ophthalmology (eye disorders).
Adding to their long list of achievements, Tetra Bio-Pharma is now tackling COVID-19.
As of July 2020, Tetra Bio-Pharma announced the FDA has positively reviewed their Pre-Investigational New Drug (PIND) application for AARDS-003, their new, THC-free, cannabinoid drug for COVID-19 patients.
The FDA stated that the nonclinical program was appropriate to support initiating Phase 1 testing of this innovative drug.
“ARDS-003 is an investigational drug designed to dampen the cytokine release syndrome and prevent the development of Acute Respiratory Distress Syndrome (ARDS),” said CEO and CRO of Tetra Brio-Pharma Dr. Guy Chamberland.
The most common cause of death for patients with severe COVID-19 is the onset of ARDS due to an infection from SARS-COV-2.
According to Yale Medicine, ARDS is a potentially fatal respiratory condition in which the lungs sustain a serious, widespread injury that diminishes their ability to provide the body’s organs with enough oxygen.
This is why patients who have been diagnosed with ARDs are required to receive supplemental oxygen therapy and to be put on a mechanical ventilator to help them breathe.
“We have extensive pre-clinical evidence that the active pharmaceutical ingredient in ARDS-003 has a profound effect in inhibiting the factors that lead to excessive immune system activation,” said Dr. Chamberland.
The Phase 1 testing, which will be a randomized, placebo-controlled human study, is scheduled to begin in December 2020.
Chamberland adds that ARDS-003 will have, “the advantage of impacting several pro-inflammatory signaling pathways, enhancing the potency of the drug to rapidly dampen the cytokine release and prevent the extreme outcomes like ARDS, which can be likened to drowning as the lungs fill with fluid.”
Tetra Bio-Pharma is a global leader in cannabinoid-derived drug discovery and development.
With their current ARDS-003 testing, they are following their mission to create groundbreaking remedies for patients suffering from debilitating health conditions.
“The FDA repeatedly stated that they want clinical trials for COVID-19 to begin as soon as possible, as long as they meet regulatory requirements. In addition, the FDA stressed the importance that the trials be designed to rapidly address the question of whether a drug has any potential efficacy in COVID-19 patients,” said Dr. Chamberland.
He concluded: “Based on this guidance, Tetra will revise its proposed clinical trial protocols to ensure that we expedite the answer to this question for the World Health Organization and the Canadian and USA governments.”