Favipiravir may improve severe COVID-19 recovery and ventilator-free survival in younger patients
DUBAI , UAE , October 11, 2022 /EINPresswire.com/ — Cellvera, a biotech company focused on developing and commercializing antiviral therapies to transform patients’ lives; today shares 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 Hydroxycholorquine & 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 Hydroxycholorquine/ 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 Hydroxycholorquine/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, rei-nforcing Cellvera’s ambition to bring forward breakthroughs in infectious diseases when they are needed most.”
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.
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
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
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