Tetra Bio-Pharma Announces Positive Preclinical Results for ARDS-003, a Novel Therapeutic for Sepsis and Viral Infections

  • ARDS-003 is a novel treatment for acute systemic inflammation and prevention of acute respiratory distress syndrome (ARDS).
  • ARDS-003 may provide steroid sparing opportunities.
  • ARDS-003 has demonstrated antiviral properties.
  • ARDS-003 developed as an oral formulation for 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 the discovery and development of cannabinoid-derived drugs, today announced new positive preclinical results from studies on infection with the live SARS-CoV-2 virus as well as a septic lung model, carried out by independent researchers.

These studies explored the potential of ARDS-003 to increase survival parameters after SARS-CoV-2 infection in the humanized ACE2 mouse model. Secondary outcomes assessed ARDS-003 against an antiviral drug, a clinical standard of therapeutic care used for patients with COVID, in animals infected with SARS-CoV-2. The 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 several pro-inflammatory mediators (i.e. cytokines) implicated in hyperinflammation and immune system dysfunction following viral infection.

Using a recent septic lung model, administration of ARDS-003 produced a significant reduction in systemic cytokine/chemokine release. Additionally, lung histology was improved, peripheral immune overactivation was reduced, and there was improved capillary perfusion in lung tissue compared to controls. An additional study assessed viral infectivity in vitro 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 enormous potential as it focuses on developing new treatments for unmet medical needs, such as lung inflammation. , viral encephalitis and brain inflammation conditions.

ARDS-003 Oral Formulation

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

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

About the ARDS-003

ARDS-003 is a First in Human (FIH) novel drug containing the active pharmaceutical agent Onternabez, a potent and selective full agonist of the cannabinoid receptor type 2 (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 termination of lung dysfunction resulting from systemic inflammation secondary to infectious clinical insult or non-infectious (McIntosh, 2020). Although the clinical profile of ARDS resulting from viral (COVID) or bacterial sepsis may vary, hyperinflammation involving a dysfunctional immune response is a common mediator of lung injury. Preclinical studies of Tetra have demonstrated that ARDS-003 decreases this hyperinflammatory response and slows disease progression.

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (ENG: JAM1) is a leader in cannabinoid-derived drug discovery and development with an FDA and Health Canada approved clinical program aimed at bringing new prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has allowed them to develop a pipeline of cannabinoid drug products for a range of medical conditions, including pain, inflammation and oncology. With patients at the heart of its business, Tetra Bio-Pharma is focused on providing the rigorous scientific validation and safety data needed for inclusion in the existing biopharmaceutical industry by regulators, physicians and insurance companies. .

For more information visit: www.tetrabiopharma.com

Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-looking statements
Certain statements contained in this press 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 (limited to, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by the use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “have the ‘intent’, ‘plan’ or ‘project’ or the negative of these words or other variations of 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, which may cause the Company’s actual results to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially current expectations include, among others, the Company’s inability to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success s the Company’s research and development strategies, including the success of this product or any other product, the applicability of discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and results of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure filings with applicable 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 the forward-looking statements, there may be other factors that cause actual results or events not to be not those anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this press release are made as of the date of this press release, and the Company undertakes no obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise, unless the applicable securities so require. legislation.

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Company Codes: OTC-QB:TBPMF, Toronto:TBP, Frankfurt:JAM1, OTC-BB:TBPMF, OTC-PINK:TBPMF

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