• The world’s largest meta-analysis conclusively revealed that Favipiravir significantly improved viral clearance rates in mild to moderate patients versus control groups 14 days after onset of symptoms (relative risk [RR] = 1.16; 95% confidence interval [CI]: 1.04, 1.30; P = 0.008)1

• The same study also examined clinical improvements in mild-to-moderate patient studies and found that Favipiravir was “significantly superior” to control groups in reducing the length of hospital stay (MD: −1.52; 95% CI: −2.82−0.23; P = 0.02)1

• These results are consistent with an earlier independent systematic review and meta-analysis of favipiravir.2 Mild to moderate patients receiving Favipiravir exhibited significantly improved viral clearance on day 7 after treatment (odds ratio [OR] = 2.49; 95% CI = 1.19-5.22; P = 0.02)2

• Favipiravir was also associated with superior clinical improvement to comparative therapy after seven days (OR = 1.60, 95% CI = 1.03–2.40, p = 0.04) and 14 days (OR = 3.03. 95% CI = 1.17–7.80, p = 0.02)

• The efficacy against COVID-19, the above studies confirmed the safety of Favipiravir in line with the other studies and real-world observations

Cellvera, a US biopharmaceutical company, today reports a summary of recent studies demonstrating the efficacy of Favipriavir against several SARS-CoV-2 variants, including Delta and Omicron, and findings from the world’s largest meta-analysis. Cellvera, a company focused on discovering, developing, and commercializing antiviral therapies across a broad spectrum of infectious diseases, holds directly, or through its affiliates worldwide exclusive worldwide rights to Avigan 200mg (Favirpiravir) and higher strength formulations of the drug branded Qifenda 400MG and 800MG, a broad-spectrum oral antiviral treatment that targets COVID-19 and at least 12 other infectious diseases. Cellvera has developed and introduced the drug in several global markets since the start of the pandemic.

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.

As novel strains of the SARS-CoV-2 virus continue to emerge, preliminary studies on SARS-COV-2 variants— Omicron and Delta—have shown that Favipiravir maintains its antiviral activity, demonstrating the inability of viruses to form resistance to Favipiravir even with prolonged exposure of virus-infected cells to the drug.23 Favipiravir remains an invaluable asset for emergency preparedness strategies against this constantly evolving COVID-19 virus and other potential future pandemics.

On the international stage, the Thailand Disease Control Department (DDC) recently announced its official position on Favipiravir, stating that “the drug was effective in treating mild and moderate symptoms and numerous patients are given Favipiravir recovered and were discharged from hospitals.4 In patients administered Favipiravir, the clinical improvement rate was 79% after 14-days of monitoring, compared to a 32.2% improvement rate in the control group. As reported by Dr. Opart Karnkawinpong, the DDC’s director- general, citing a Thairesearch onn the use of Favipiravir conducted by the Clinical Research Centre of the Faculty of Medicine (Siriraj hospital), the Bamrasnaradura Institute of Infectious Diseases, the Department of Disease Control and the Medical Sciences Department. Dr. Opart said that the study shows that Favipiravir has statistically significant efficacy in the treatment of COVID-19.

Cellvera recently announced their support of the UK government and the University of Oxford in their national priority platform trials of COVID-19 treatments. Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses (PRINCIPLE) is one of the world’s most extensive trials currently in a community setting, seeking treatments for outpatient use. In April 2021, the University of Oxford announced that Favipiravir would be investigated in the UK; a trial was set up with the intention that drugs shown to have a clinical benefit could be rapidly introduced into routine National Health Service (NHS) care. However, except for Favipiravir, the other three drugs selected for this trial were discontinued due to futility within weeks, with a continued expansion of the number of patients being administered Favipiravir.

Since 2014, Favirpiravir has been extensively studied and evaluated in 40 clinical trials before the COVID-19 pandemic. In some prior trials, like PRESECO in the US, Favipiravir did not demonstrate efficacy due to insufficient dosage available to patients or late treatment. At the same time, the mounting evidence from the world’s large meta-analysis points to a proven efficacy of Favipiravir against SARS-COV-2 and its variances. However, Favipiravir continues to demonstrate significant clinical improvements and promotes enhanced viral clearance in mild-to-moderate COVID-19 patients as the data from several clinical trials showed that:

• No viral resistance to Favipiravir, even with prolonged exposure of virus-infected cells to the drug.

• Favipiravir maintains its antiviral activity against SARS-COV-2 variants—Omicron and Delta⁴

• Favipiravir was significantly superior to control groups in reducing the length of hospital stay; it also improved viral clearance rates in mild to moderate patients versus control groups 14 days after onset of symptoms.

• More than 70% of mild to moderate patients experienced relief of symptoms on day 3, clinical improvement, and remission on day 7, and more than 90% achieved full recovery by day 14.

• COVID-19 patients with hypertension and diabetes experienced a significant decrease in fever reduction and cough relief when treated with favipiravir compared to the standard of care.

Dr. Richard Kaszynski, Chief Medical Officer at Cellvera, said: “Scientific evidence should always dictate our narrative. Cellvera monitors and remains actively vigilant of the constantly evolving clinical landscape.

Among the hierarchy of evidence-based medicine, systematic reviews and meta-analyses have always assumed the pinnacle of the evidence pyramid and have informed our decisions in the setting. The two recently published meta-analyses consistently showing the clinical benefits of Favipiravir have been tremendously encouraging. As an emergency care physician with extensive experience using favipiravir, I have witnessed first-hand the immense potential the drug represents under appropriate administration and am confident that it will become a potent addition to our existing armamentarium in the fight against COVID-19.”

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, chemistry, and senior software engineers.

For more information: https://www.cellvera.com

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 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: https://holdings.fujifilm.com

Press & Media Contact:
Mary O’Brian, CEO
Cellvera
Tel: +353-874589775 | +971501164708
Email: Mary.obrian@cellvera.com
Website: https://www.cellvera.com

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Website: www.cellvera.com