Health Canada acknowledges that the preclinical safety data are robust and sufficient to file a Clinical Trial Application aimed at treating hospitalized COVID-19 patients at risk of developing ARDS
ARDS is the leading cause of mortality in patients with COVID-19 and develops in 20-67% of critically ill patients diagnosed with COVID-19
There is currently no standard, approved treatment for ARDS rendering the indication a significant unmet medical need
OTTAWA, ON / ACCESSWIRE / March 30, 2021 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1), a biopharmaceutical pioneer in immunomodulator drug discovery and development is excited to announce that Health Canada supports the filing of a Clinical Trial Application for assessing their novel drug candidate, ARDS-003, in patients with COVID-19.
ARDS-003 is a new patent protected therapeutic developed to treat hyperinflammatory conditions, such as those seen in patients suffering from COVID-19 viral infections. Shareholders have been waiting for this moment since late autumn 2020. Health Canada, like other regulatory agencies, had to complete a full review of the animal toxicology and safety data to ensure that the new drug, ARDS-003, is safe for human use. This takes more time than assessing the potential safety of an existing, repurposed drug.
Tetra's trial will be the first worldwide drug which involves the use of an injectable sterile synthetic cannabinoid in patients infected by COVID-19. Tetra will use this study to demonstrate that its ARDS-003 drug can help prevent the acute respiratory distress seen in serious complications of COVID-19.
The proposed study is a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ascending doses of ARDS-003 in hospitalized COVID-19 patients with pneumonia and at risk of developing acute respiratory distress syndrome.
Seeking guidance on clinical study protocol to be conducted in patients with COVID-19 is a pre-requisite of the Health Canada regulatory process for COVID-related trials. The Office of Clinical Trials of Health Canada's Therapeutic Products Directorate acknowledged that Tetra's extensive nonclinical data, including genotoxicity, safety pharmacology and toxicities studies, assessing the safety and pharmacokinetic profile of the investigational drug meet the authority's requirements for a New Molecular Entity and granted the Company the approval for filing a clinical trial application in patients infected with Sars-CoV-2 (COVID-19). The authorities also agreed on the proposed study design, target population, and primary and secondary objectives and endpoints of the study in severe COVID-19 patients. To this end, contingent to Health Canada's accelerated review process for Covid-related trials, the Company's drug ARDS-003, will be evaluated in COVID-19 patients.
The investigational drug is designed to dampen the cytokine release syndrome and will be administered in combination with dexamethasone. The Company is not making any express or implied claims that its product has the ability to eliminate, cure and/or contain the COVID-19 virus at this time.
Dr. Guy Chamberland, CEO and CRO commented, "Health Canada acknowledges the excellence of our preclinical data package. Getting the green light from the authorities to administer this trial in patients was the last missing step for Tetra to initiate ARDS-003 clinical development in COVID-19 patients. The preliminary approval of the study protocol, and prior review of the preclinical safety data, will allow us to move promptly through the Health Canada CTA revision process. This is extremely positive feedback for Tetra and its shareholders. Not only are we able to advance to COVID-19 patients, but we can leverage the approved preclinical safety data to investigate other indications with ARDS-003, such as sepsis".
Severe COVID-19-induced hyperinflammatory syndrome
ARDS is the leading cause of mortality in COVID-19 patients and develops in 20-67% of critically ill patients diagnosed with COVID-19 (Yang et al. 2020; Vittori et al. 2020) and 76% of patients requiring ICU care (Tan et al. 2020). Studies report that of those COVID-19 patients who are critically ill, profound acute hypoxemic respiratory failure secondary to ARDS represents the leading finding, and that 30-100% of these patients require mechanical ventilation (Anesi 2020). Further, additional organ systems including the cardiovascular system are profoundly impacted by the hyperinflammation in COVID-19 patients (Capone et al. 2020; Hendren et al. 2020). Presently, no standard, approved treatment for hyperinflammation and associated ARDS or multi-organ dysfunction syndrome (MODS; a common cause of death) exists for these patients, rendering the indication a significant unmet medical need. Targeting hyperinflammation via immunosuppressive or anti-inflammatory agents is likely to be beneficial in COVID-19-associated CRS. The use of low-dose dexamethasone is part of standard of care for COVID-19 and has been correlated with decreased COVID-19 mortality and reduction in need for mechanical ventilation (Sterne et al. 2020; Siemieniuk et al. 2020). Given that the anti-inflammatory effect of ARDS-003 is broader than the anti-inflammatory effect of dexamethasone and presents a safer safety profile, it is believed that the addition of ARDS-003 to dexamethasone standard of care treatment will result in additional benefit for the patients.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1) is a biopharmaceutical pioneer in immunomodulator 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. 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.
For more information visit: www.tetrabiopharma.com
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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.
SOURCE: Tetra Bio-Pharma
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