Tetra Bio-Pharma Announces Positive Results in Animal Studies for Treatment of Hyperinflammatory Lung Injury

Tetra Bio-Pharma Inc. (TSX:TBP) (OTCQB:TBPMF) is a leader in cannabinoid-derived drug discovery and development. The company announces the results of an experimental study of its ARDS-003 investigational new drug in a model of lung injury.

Tetra Bio-Pharma is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a FDA and a Health Canada approved clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Our evidence-based scientific approach has enabled us to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.

Tetra Bio-Pharma has recently completed pre-clinical studies demonstrating an anti-inflammatory effect of its investigational new drug, ARDS-003, in an animal model of lung injury known as “induced pulmonary fibrosis” (IPF). Pulmonary fibrosis occurs when lung tissue is scarred, often as a result of extreme or prolonged inflammation, and results in a stiffening of lung tissue that may lead to respiratory problems and, in extreme cases, respiratory failure. While human conditions associated with lung injury may be caused by autoimmune disorders or viral infections, application of inflammatory agents such as bleomycin has been shown to induce similar effects in animal models.

To-date, no animal model of COVID-19 has been established and widely accepted as recapitulating the clinical disease seen following SARS-CoV-2 infection. Thus, alternative models of inflammation-driven respiratory conditions leading to pulmonary fibrosis are currently being used to evaluate the effectiveness of treatments to mitigate the organ disfunction seen in COVID-19. Administration of ARDS-003 to animals in which lung tissue has been inflamed, using the bleomycin induced IPF model, has produced promising results. ARDS-003 was able to reduce the levels of key inflammatory cytokine markers, such as IL-6. Importantly, this anti-inflammatory effect was reflected in a reduced fibrosis when the lung tissue was analyzed after 20 days of treatment.

To further confirm that a comparable effect may occur in humans, ARDS-003 was studied using models of inflammation in human lung cells and was similarly found to reduce the effects of fibrosis-associated inflammatory pathways. Together, these results present positive evidence for the use of ARDS-003 as an experimental therapeutic treatment for patients with severe inflammatory disorders such as COVID-19.

Dr. Guy Chamberland, CEO and CRO commented, “ARDS-003 is an investigational new drug designed to dampen the cytokine release syndrome and prevent the development of Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious, life-threatening condition that develops as a result of infection by SARS-CoV-2, the virus that causes COVID-19. We will soon be submitting the application for our Phase I clinical trial to demonstrate safety in healthy volunteers and define the pharmacokinetic profile of ARDS-003 prior to initiating studies in patients with COVID-19. 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.”