Tetra Bio-Pharma Announces Results of Artificial Intelligence Study of ARDS-003 Combined with Favipiravir

The combination of ARDS-003 and Favipiravir presents viable treatments against viral infections.
Results from the PIONEER clinical trial shows Favipiravir may improve severe COVID-19 recovery and ventilator-free survival in younger patients.
Tetra and Cellvera to develop an orally administered treatment, ARDS-003, in combination with Favipiravir.

MONTREAL, Dec. 6, 2022 /CNW/ – 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 significant results from the study of Onternabez combined with Favipiravir against ARDS (acute respiratory distress syndrome), Sepsis, and COVID-19 through PREPAiRE, an AI (Artificial Intelligence) powered platform which purposely integrates target identification, validation, lead discovery optimization, drug synthesis, and preclinical testing. Leveraging the power of AI enables more answers and greater insights, faster.

The power of Artificial Intelligence. (CNW Group/Tetra Bio-Pharma Inc.)

Results from the study demonstrate that Tetra’s investigational therapeutic, ARDS-003, which contains the active pharmaceutical ingredient Onternabez, acts against various ARDS and Sepsis targets, such as IL-6 and IL-8. Onternabez plays an important role in mitigating the inflammatory response in various targets of inflammatory conditions. Favipiravir acts against different SARS-CoV-2 targets, such as spike glycoprotein and nucleoprotein. The interaction between Favipiravir and Onternabez against SARS-COV-2 yields a positive Molecule Synergy probability which is considered significant and justifies the combination of the two drugs to create a new therapeutic that is expected to be beneficial to increase treatment efficacy and reduce the duration of disease. Favipiravir can control the source of infection. Onternabez would contribute to the antiviral efficacy and can control the result of infection (i.e., the inflammatory response).

Dr. Guy Chamberland, CEO and Chief Regulatory Officer at Tetra commented “We are very pleased by these artificial intelligence results as well as the recent positive results from the PIONEER trial. This underscores our commitment with Cellvera to developing an innovative combination drug candidate to combat viral diseases. We are more excited than ever about our collaboration with Cellvera and the possibility of delivering the next scientific breakthroughs.”

About the PIONEER clinical trial – Cellvera’s Press Release

On October 11, 2022, Cellvera, shared an update that the UK’s Chelsea and Westminster NHS Foundation Trust sponsored PIONEER trial involving Avigan® (Favipiravir) vs. standard care confirms a reduction in deaths by 22% compared to the placebo group. Cellvera, directly or through their affiliates, holds exclusive worldwide rights to brand originator Favipiravir under the brand names Avigan® 200MG and Qifenda® 400mg/800MG and the injectable formulation. This broad-spectrum therapeutic has shown antiviral effects against SARS-CoV-2 (the virus responsible for causing COVID-19) and more than 20 other RNA viruses.

Favipiravir may improve severe COVID-19 recovery, ventilator-free survival in younger patients was the headline-grabbing statement after a presentation made by Dr/ Christopher M. Orton, MD, Consultant Respiratory Physician at Royal Brompton Hospital, London, during a presentation at the European Respiratory Society International Congress.

PIONEER: A Randomised Controlled Trial of Early Intervention in Patients Hospitalized with COVID-19: Favipiravir verses Hydroxychloroquine & azithromycin & zinc vErsEs Standard CaRe. The international PIONEER study, sponsored by Chelsea and Westminister Hospital NHS Foundation Trust, recruited 499 patients (median age, 58.9 years; 61% men) from the U.K., Brazil, and Mexico who were admitted to hospitals with proven or suspected COVID-19 from May 2020 to May 2021. Led by an expert clinical team and supported by NEAT ID, the study was financially supported by a group of leading organizations and individuals who committed funds to the trial, including Imperial College, Chelsea and Westminster Hospital NHS Foundation Trust, XTX Markets, medical research charity LifeArc, KU Leuven, and Ageas, and a broad community of individual donors.

Researchers reported that treatment with oral Favipiravir benefited recovery and mechanical ventilation-free survival among patients younger than 60 years hospitalized with COVID-19. The primary outcome was time to a 2-point improvement in the WHO ordinal scale or discharge, whichever occurred first. Secondary outcomes focused on mortality and health care resource utilization. When findings were analyzed for patients aged younger than 60 years, researchers observed a more significant numerical difference in deaths, with an approximate 50% reduction and a significant difference in mechanical ventilation-free survival (p=.02)

The PIONEER trial compared two potential antiviral treatments for early intervention in patients with COVID-19. The treatments initially selected were Avigan® (Favipiravir) and an Hydroxychloroquine/ azithromycin & zinc combination. The treatments were chosen due to their potential to be used for early intervention by inhibiting the virus’s ability to replicate and prevent the progression of the disease to the later, more severe phase. However, acting on guidance from the MHRA, the combination treatment arm of Hydroxychloroquine/azithromycin & zinc was dropped while safety issues around HCQ were being investigated. The PIONEER study continued with only one arm, that of Avigan® (Favipiravir) vs. standard care.

Research organizations involved:

Chelsea and Westminster Hospital NHS Foundation Trust
Royal Brompton Hospital
Imperial College

FUJIFILM Toyama Chemicals provided Avigan® with relevant safety information to obtain the official approvals necessary to start the trial. Favipiravir, which has a long and verified history of safety and efficacy, was initially developed by FujiFilm Toyama Chemical Co and approved in Japan (2014) to treat pandemic influenza. Favipiravir is a selective inhibitor of viral RNA-dependent RNA polymerase (RdRP) with potent antiviral activity against single-stranded RNA viruses, including coronaviruses. It targets the protein needed for the coronavirus to replicate, making it impossible for the virus to copy itself. The broad-spectrum antiviral drug is effective against 12 families of viruses, including Coronaviruses (COVID, MERS, SARS), Filoviruses (EBOLA, MARBURG), Flaviviruses (ZIKA, WEST NILE, DENGUE), RABIES, NOROVIRUS, and many others.

Mary O’ Brien Chief Executive Officer commented on data made available by Dr. Orton to colleagues at the European Respiratory Society International Congress from the PIONEER trial; “The recent presentation re-confirms the potential Favirpiravir has to save people’s lives and reduce the severity of the COVID-19 infection. We already know the profound impact Avigan® 200MG and Qifenda® 400MG has made in controlling the pandemic. It was one of the first oral antivirals to be approved as a treatment for COVID-19 and is already used by governments as the first line of defense in treating the virus. With these compelling results, and more to come, we are optimistic that Avigan® and higher strength formulations of Favirpiravir will grow as an essential drug in the global effort to fight this and future pandemics, reinforcing Cellvera’s ambition to bring forward breakthroughs in infectious diseases when they are needed most.”

About FAVIPIRAVIR

Favipiravir, discovered and developed by FUJIFILM, was first approved under the brand name Avigan® by regulators in Japan in 2014 as a potent broad-spectrum antiviral treatment for influenza. This antiviral drug is effective against 12 families of viruses, including coronaviruses (COVID, MERS, SARS), Filoviruses (EBOLA, MARBURG), Flaviviruses (ZIKA, WEST NILE, DENGUE), RABIES, NOROVIRUS, and many others. Favipiravir works by inhibiting a viral enzyme called RNA polymerase, preventing viral replication within human cells. Favipiravir has potent antiviral activity against single-stranded RNA viruses, including coronaviruses. This is the protein responsible for “building” the viral proteins. Favipiravir can target the protein necessary for the coronavirus to replicate, making it impossible for the virus to copy itself.

About Cellvera

Cellvera is a biopharmaceutical company focused on discovering, developing, and commercializing oral therapies and monitoring tools to address the unmet medical needs of patients with life-threatening viral diseases.

Leveraging the Company’s deep understanding of antiviral drug development, nucleotide chemistry, biology, biochemistry and virology, Cellvera has built a nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases.

Currently, Cellvera is focused on the clinical and commercial development of orally available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). Driven to Discover. Cellvera’s team includes PhDs in computational biology, biochemistry, and chemistry, as well as senior software engineers. www.cellvera.com

About Global Response Aid (GRA)

Agility (KSE/DFM: AGLTY), one of the world’s leading logistics companies and CELLVERA, an innovative pharma research, development and commercialization company based in Dubai, established Global Response Aid (GRA) to address the market challenges created by the COVID-19 pandemic and other threats to public health. GRA delivers innovative, effective healthcare solutions through a range of pharmaceutical products and technology platforms. It works closely with governments, regulatory authorities, hospitals, clinics, healthcare providers, life sciences companies, NGOs and public institutions to develop strategies that allow them to tackle public health challenges. For more information: www.globalresponseaid.com

About FUJIFILM

FUJIFILM Corporation, Tokyo, Japan is one of the major operating companies of FUJIFILM Holdings Corporation. The company brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information holdings.fujifilm.com

About Tetra Bio-Pharma

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.