Tetra Bio-Pharma Announces Health Canada Authorization to Proceed with its Oral ARDS-003 New Drug in Human Trial
Montreal, QC - TheNewswire - March 10, 2023 - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP) (OTC:TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discovery and development is pleased to announce Health Canada has issued the Company a No Objection Letter (NOL) to proceed with its first in human clinical trial using oral ARDS-003 to treat various immunomodulatory conditions, in Canada.
Oral ARDS-003 is a new therapeutic positioned to modulate acute systemic inflammation and prevent sepsis, acute respiratory distress syndrome (“ARDS”), and organ damage.
The NOL provides the acknowledgement of drug candidacy and authority to proceed with Tetra’s Phase 1 clinical trial to assess the safety, tolerability, and pharmacokinetics of a single ascending dose of oral ARDS-003 in healthy volunteers. The results will guide further development of the drug for patients with hyper inflammatory conditions such as Acute Respiratory Distress Syndrome (ARDS).
Tetra received $4.5M in support from the Government of Quebec for the clinical development of ARDS-003 in the indication of acute respiratory distress syndrome, whether or not it is caused by COVID-19, as well as in patients with sepsis. The receipt of the NOL was one of the last conditions to be met to allow the company to draw on this investment.
Dr. Guy Chamberland, CEO and Chief Regulatory Officer at Tetra, commented, “We are excited to see our novel drug candidate, oral ARDS-003, moving forward in a clinical setting. As few as 1 out of 1,000 compounds make it into Phase 1 human trials. The development of effective, out-patient, oral therapies that either directly address viral infection or treat associated complications such as inflammation, organ damage, or fibrosis, is important in a national response to future pandemics or health emergencies. With over 12 years of preclinical efficacy research in sepsis and cytokine hyperinflammatory reactions, we are very confident that oral ARDS-003 will be an effective drug with strong commercial potential.”
A Promising Treatment
Oral ARDS-003 is a novel First in Human (FIH) drug candidate containing the active pharmaceutical agent, Onternabez, a potent and selective full agonist of the type 2 cannabinoid receptor (CB2R), an essential immunomodulatory target. Oral ARDS-003 is positioned to modulate acute systemic inflammation and prevent sepsis, ARDS, and organ damage. While the clinical profile of ARDS arising from viral (COVID) or bacterial sepsis can vary, hyperinflammation involving a dysfunctional immune response is a common mediator of lung damage. Tetra's pre-clinical studies have demonstrated that its drug candidate decreases this hyperinflammatory response and slows disease progression.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTC-Pink: TBPMF) (FRA: JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them 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 they 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.
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Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
For further information, please contact Tetra Bio-Pharma Inc.:
Ms. Natalie Leroux
Phone: + 1 (833) 977-7575
SOURCE Tetra Bio-Pharma Inc.