FDA Provides Positive Feedback on Tetra Bio-Pharma's Pre-Investigational New Drug Application for ARDS-003 to Be Studied in COVID-19 Patients at Risk of Developing Acute Respiratory Distress Syndrome (ARDS)
FDA stated that the nonclinical program was appropriate to support initiating studies in COVID-19 patients
OTTAWA, CANADA / ACCESSWIRE / July 16, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSXV:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is excited to announce that the U.S. Food and Drug Administration (FDA) has favorably reviewed the company's Pre-Investigational New Drug (PIND) application for ARDS-003. 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.
Dr. Guy Chamberland, CEO and CRO commented, "ARDS-003 is an investigational drug designed to dampen the cytokine release syndrome and prevent the development of Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious, life-threatening condition that develops as a result of infection by SARS-COV-2. The Company is not making any expressed or implied claims that its product has the ability to eliminate, cure and/or contain the COVID-19 or the SARS-COV-2 virus at this time.
Tetra is extremely pleased with the positive feedback provided by the FDA for the development of ARDS-003, an innovative novel investigational new drug for COVID-19 patients. Overall, the FDA agreed with Tetra's proposed active substance and finished product specifications as well as the stability programs. The FDA stated that the nonclinical program was appropriate to support initiating phase 1 study. The FDA confirmed that assessments such as blood compatibility and local irritation, which are typically required for intravenous drug products will be required. These are part of Tetra's nonclinical program and are currently ongoing. The FDA also stated that no additional nonclinical safety studies would be required to initiate phase 2 studies in SARS-COV-2 patients.
The majority of toxicology studies were not completed at the time of the submission of the PIND meeting package, including how humans may metabolize ARDS-003. The FDA stated that humans may metabolize cannabinoids differently than standard nonclinical toxicology test species such as rodents and canines (e.g. cannabidiol also known as CBD). Therefore, Tetra's development program needed to identify disproportionate or human specific metabolites and address the safety of human major metabolites. The safety of human major metabolites needs to be emphasized given the concerns that the FDA raised over the nonclinical safety program of Epidiolex (CBD). Tetra is confirming that these toxicology studies have been completed, and we did not identify any disproportionate or human specific metabolite for ARDS-003.
COVID-19 Pandemic impact on global health care
The COVID-19 pandemic is having a major impact on global health care. Hospitals and emergency clinics have been hard hit by this pandemic and some intensive care units (ICUs) have been reaching overcapacity thereby limiting access to optimal care for some severely ill patients. As the pandemic completes its first wave of infection, physicians and scientists have learned a tremendous amount about the consequences of the cytokine release syndrome, often referred to as the cytokine storm. The clinical picture that has evolved from the risk and consequences of acute respiratory distress syndrome (ARDS) requiring oxygen therapy to potential consequences caused by the cytokine release syndrome. These consequences include scarring of the lungs (pulmonary fibrosis) to organ injury caused by the decrease in blood perfusion to the tissue. The medical community is in urgent need of drugs that can reduce the strength and duration of the severe inflammation. It is anticipated that this type of new drug would favorably impact health care and possibly reduce the negative health outcomes post infection.
Dr. Guy Chamberland, CEO and CRO commented, "We received the response from the FDA last week and are excited to share this feedback with our shareholders. The feedback received is extremely positive news because now we have confidence that the rodent and nonrodent species used in the nonclinical toxicology study will provide a relevant assessment of the safety profile of the new drug (ARDS-003) prior to first-in-human trials. The impact of this outcome will result in a decreased cost to run the drug development program because any human-specific metabolite or disproportionate metabolite requires additional toxicology testing and has a significant effect on the overall cost of and time to complete the program. This will allow us to design the program in such a way that we can potentially further increase shareholder value." The FDA also provided detailed feedback on the proposed Phase 1 and 2 clinical trial protocols. "The FDA repeatedly stated that they want clinical trials for COVID-19 to begin as soon as possible, as long as they meet regulatory requirements. In addition, the FDA stressed the importance that the trials be designed to rapidly address the question of whether a drug has any potential efficacy in COVID-19 patients. Based on this guidance, Tetra will revise its proposed clinical trial protocols to ensure that we expedite the answer to this question for the World Health Organization and the Canadian and USA governments. In addition, Tetra is planning to initiate a study in COVID-19 patients in parallel to conducting the phase 1 trial in healthy volunteers. Tetra expects to start the Phase 1 trial in late September 2020. The treatment phase of the study should be completed within the two months followed by the analysis and reporting phase. Our plan is to obtain preliminary efficacy data from a small well-controlled clinical trial as soon as we can", stated Dr. Chamberland.
"Many companies have joined the quest for an effective treatment for the cytokine storm. A number of these companies have repurposed drugs, including arthritis-type drugs hoping that these older molecules will be effective. ARDS-003, however, is an innovative molecule that has been studied for more than a decade, specifically as a treatment for sepsis and severe inflammatory reactions. Tetra is not repurposing our drug for the COVID-19 pandemic. Rather, we are accelerating a drug development program of a drug designed to treat this type of serious health condition. This is in-line with Tetra's goal to develop patent protected innovative therapies for patients with serious health conditions. Tetra's research team works hard to develop intellectual property to ensure that our products, and their markets, are well protected providing value for our share-holders" said Guy Chamberland, Chief Executive Officer and CRO of Tetra Bio-Pharma.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. 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 bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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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.:
Tetra Bio-Pharma Inc.
Dr. Guy Chamberland, M.Sc., Ph.D.
Chief Executive Officer
Phone: + 1 (833) 977-7575
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
SOURCE: Tetra Bio-Pharma
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