TBP Tetra Bio Pharma Inc

• ARDS-003 is a novel therapeutic for acute systemic inflammation and prevention of acute respiratory distress syndrome (ARDS).
• ARDS-003 may offer steroid-sparing opportunities.
• ARDS-003 has demonstrated antiviral properties.
• ARDS-003 developed as an oral formulation for an immediate release administration.

OTTAWA, ON, Aug. 10, 2022 /PRNewswire/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development announced today new positive preclinical results from live SARS-CoV-2 virus infection studies as well as a septic lung model, carried out by independent researchers.

These studies explored the potential of ARDS-003 to increase survival metrics following SARS-CoV-2 infection in the humanized ACE2 mouse model. Secondary outcomes evaluated ARDS-003 against an antiviral drug, a clinical standard of care therapeutic used for patients with COVID, in SARS-CoV-2 infected animals. Results indicate that compared to placebo, ARDS-003 dose dependently reduced signs of morbidity and mortality, including respiratory distress. ARDS-003 also outperformed the antiviral drug in reducing multiple proinflammatory mediators (i.e., cytokines) involved in hyperinflammation and immune system dysfunction following viral infection.

Using a recent septic lung model, the administration of ARDS-003 produced a significant reduction of systemic cytokine/chemokine release.  In addition, lung histology was improved, peripheral immune hyper activation was reduced, and there was an improvement in capillary perfusion in lung tissue compared to controls.  An additional study evaluated in vitro viral infectivity and demonstrated dose dependent inhibition of viral replication.

Guy Chamberland, CEO and CRO at Tetra commented "ARDS-003 is a clinical stage asset that has a huge potential as it is focused on developing novel treatments for unmet medical needs, such as lung inflammation, viral encephalitis, and brain inflammation conditions."

Further to the ARDS-003 injection formulation, Tetra's research team has developed an oral formulation using its proprietary technology for an immediate release administration that can be administered for longer term care in an outpatient setting. ARDS-003 has the potential to reduce the cytokine storm associated with CAR T immunotherapy complications and has been shown to have synergistic antiviral effects in several viral in vivo infection models. 

Dr. Chamberland further commented "ARDS-003, for example, could be used as an adjunct to Paxlovid or other antivirals to help reduce the morbidities associated with prolonged infection by SARS-CoV-2 and other viruses.  In the case of COVID, the treatment period with ARDS-003 could be extended to continue to improve clinical outcome and prevent the rebound effect observed in immunocompromised patients receiving existing antivirals."

ARDS-003 is a novel First in Human (FIH) drug product containing the active pharmaceutical agent, Onternabez, a potent and selective full agonist of the type 2 cannabinoid receptor (CB2R), an important immunomodulatory target. ARDS-003 is positioned to modulate acute systemic inflammation and prevent Sepsis, ARDS, and organ damage - ARDS represents the severe end of lung dysfunction resulting from systemic inflammation secondary to infectious or non-infectious clinical insult (McIntosh, 2020).  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 preclinical studies have demonstrated that ARDS-003 decreases this hyperinflammatory response and slows disease progression.

Tetra Bio-Pharma (TSX: TBP) (OTCQB: 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.

For more information visit: www.tetrabiopharma.com

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Forward-looking statements
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.

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SOURCE Tetra Bio-Pharma Inc.