- 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
/PRNewswire/ - 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.
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
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information. All statements, other than of historical fact, that
address activities, events or developments that the Company
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product or any other product, the applicability of the
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Company's public disclosure record on file with the relevant
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SOURCE Tetra Bio-Pharma Inc.