FDA Provides Positive Feedback on Tetra Bio-Pharma's Application for ARDS-003 Clinical Development in COVID-19 Patients

Rhea-AI Summary

The FDA has favorably reviewed Tetra Bio-Pharma's preclinical data for ARDS-003, a therapeutic aimed at treating hospitalized COVID-19 patients at risk of developing ARDS. This review, part of the Coronavirus Treatment Acceleration Program, confirms the drug's safety for human use and endorses the clinical trial's design. The upcoming trial will evaluate ARDS-003's safety and efficacy in combination with dexamethasone in COVID-19 patients. Current ARDS conditions have a significant mortality rate, indicating a critical unmet medical need that ARDS-003 aims to address.

Positive

• FDA approval of preclinical safety data for ARDS-003 allows the filing of an IND.
• The drug targets a significant unmet medical need in COVID-19 patients.
• The clinical trial design has been positively reviewed, paving the way for further development.

Negative

• None.

• FDA acknowledged that the preclinical safety data are acceptable to file an Investigational New Drug Application (IND) aimed at treating hospitalized COVID-19 patients at risk of developing ARDS

OTTAWA, ON / ACCESSWIRE / April 5, 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 pleased to announce that the U.S. Food and Drug Administration (FDA) has favorably reviewed the preclinical data package and clinical development plan of ARDS-003 to treat COVID-19 patients.

The review was conducted within the framework of the Coronavirus Treatment Acceleration Program (CTAP), the FDA's expedited process for investigational therapies to treat COVID-19 patients. Overall, the FDA agreed with the animal toxicology and safety data to ensure that ARDS-003 is safe for human use, and approved the sample size, safety procedures and duration of treatment in severe COVID-19 patients. As a result of this feedback, the Company looks forward to filing an Investigational New Drug Application to initiate the clinical trial.

The proposed patient 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 FDA regulatory process for COVID-related trials, as it is for Health Canada.

Dr. Guy Chamberland, CEO and CRO commented, "I'm very pleased with the FDA feedback on our data package and clinical strategy. Such feedback gives us a great insight on the authority's positive perception of our product and will facilitate the IND review process. I'm confident that we are now aligned with the authorities for the development plan of ARDS003".

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. 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.

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.

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

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.

For further information, please contact Tetra Bio-Pharma Inc.:

Tetra Bio-Pharma Inc.
Ms. Natalie Leroux
Phone: + 1 (833) 977-7575
Email: investors@tetrabiopharma.com
media@tetrabiopharma.com

SOURCE: Tetra Bio-Pharma

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FAQ

What is the FDA's feedback on Tetra Bio-Pharma's ARDS-003?

The FDA has reviewed and approved Tetra Bio-Pharma's preclinical safety data, allowing the company to file an Investigational New Drug Application.

What is ARDS-003 intended to treat?

ARDS-003 is designed to treat hospitalized COVID-19 patients who are at risk for developing acute respiratory distress syndrome.

When will the clinical trial for ARDS-003 begin?

The company plans to initiate the clinical trial following the filing of the Investigational New Drug Application with the FDA.

How does ARDS-003 compare to current treatments for COVID-19?

ARDS-003 is intended to enhance the anti-inflammatory effects of standard care treatments like dexamethasone, targeting hyperinflammation associated with COVID-19.

What is the significance of the FDA's review under the CTAP program?

The CTAP program is designed to expedite the development of investigational therapies for COVID-19, highlighting the urgency and importance of ARDS-003 in treating severe cases.