Completed Phase 3 clinical study paves way for approval request
DUBAI, UAE, Sept. 23, 2020 /PRNewswire/ -- Healthcare solutions provider Global Response Aid (GRA) and Dr. Reddy's Laboratories announced that the anti-viral drug Avigan® produced promising results in a single-blinded, placebo-controlled Phase 3 clinical study conducted in Japan with the sponsorship of FujiFilm Toyama Chemical.
Patients who received Avigan® recovered from COVID-19 symptoms 2.8 days earlier, on average, compared with the control group. Analysis showed patients had a statistically significant higher probability to recover when administered Avigan® compared with the patients not receiving the drug.
The study involved 156 hospitalized patients showing COVID-19 induced pneumonia, and divided in two groups or "arms." Patients in the first arm received Avigan®. Patients in the second arm received a placebo looking identical to the drug. A statistically significant percentage of the patients in the group receiving Avigan® had a rapid reduction in viral loads.
The study aimed to measure recovery from pneumonia and COVID-19 symptoms. It monitored patients' temperature, oxygen saturation and CT scan imaging of the lungs. Time-to-alleviation of the symptoms was measured between the first administration of the drug (or placebo) and the moment when SARS-COV-2 induced symptoms became undetectable.
Shortening recovery time lowers the risk of complications in patients and, importantly, significantly reduces the risk that a patient will spread the virus. The latest results open the possibility of treating patients with mild or moderate cases of COVID-19 in outpatient settings, which also could help slow the spread of the pandemic.
Avigan®, which contains the active ingredient Favipiravir, was developed by FujiFilm Toyama Chemical in the 1990s as an anti-influenza drug. GRA, Dr. Reddy's Laboratories, and FujiFilm Toyama recently entered a global licensing agreement covering the production, marketing and distribution of Avigan®.
Results of the Japan trial suggest the effectiveness of Avigan® as a treatment to prevent COVID-19 patients from progressing from mild to more severe or critical clinical stages of the disease, and to accelerate recovery from COVID-19 symptoms.
GRA CEO Mitch Wilson said the FujiFilm Toyama study represents a breakthrough in the fight against COVID-19, and opens the way for approval of Avigan® as a COVID-19 treatment in Japan. The drug is already approved in India, Russia, Indonesia and other countries around the world.
"The findings from this university-led study are the proof we all need to tackle this pandemic," Wilson said. "We are actively working with regulators in order to speed up the approval in major markets. Because Avigan® is manufactured in pill form the drug can be self-administered from home, which reduces patient load in hospitals and on medical staff. Furthermore Avigan® does not require refrigerated transport or storage making it much easier to quickly distribute the drug to countries and markets with limited cold storage infrastructure"
Avigan® is the subject of clinical trials in COVID-19 patients in several countries. It was used to treat COVID-19 patients in studies in China's Hubei province, led by the China-Japan Friendship Hospital. It is undergoing testing in the United States in a multi-site Phase 2 study involving initially hospitalized patients, a trial sponsored by FujiFilm Toyama Chemical. It also is the subject of an investigator-initiated Phase 2 study in subjects with mild or asymptomatic COVID-19 being conducted by the Stanford University School of Medicine.
Avigan® Tablet was approved for manufacture and sale in Japan in 2014 as an influenza anti-viral drug. The drug is to be considered for use only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza anti-viral drugs are either not effective or insufficiently effective, and the Japanese government decides to use the drug as a countermeasure against such influenza viruses.
GRA is a Dubai-based company established by global logistics leader Agility (KSE: AGLTY) and AiPHARMA a biotechnology company to procure and develop certified diagnostic, testing and protective products and services used in the detection, treatment and prevention of COVID-19 and other public health threats.
About Global Response Aid (GRA)
Global Response Aid, based in Dubai, provides solutions to public health challenges. GRA was established by global logistics leader Agility and AiPHARMA a biotechnology company to procure and develop certified diagnostic, testing and protective products and services used in the detection, treatment and prevention of COVID-19 and other public health threats. GRA works with trusted manufacturers to source safe, effective products for governments, health authorities and public institutions; frontline medical facilities; NGOs; and companies looking to safeguard workers and workplaces. GRA-sourced products include ventilators, thermal detection equipment, thermometers, masks, goggles, protective suits, nitrile gloves, cleaning and sanitation supplies, and point-of-care test kits. GRA's mobile phone app helps stop the spread of viruses through the use of community-driven contact tracing and alerts. GRA also deploys Mobile Diagnostic Testing Vehicles and trained teams that perform COVID-19 testing at schools and workplaces. For more information, please visit https://globalresponseaid.com/ [https://globalresponseaid.com/]
FUJIFILM Toyama Chemical Co., Ltd. conducts the research, development, manufacture, and sales of radiopharmaceuticals and small molecule pharmaceutical products. Under close cooperation with FUJIFILM Corporation, it aims to develop innovative diagnostic and therapeutic radiopharmaceuticals, as well as therapeutic drugs having unique mechanisms of action in the fields of "oncology," "central nervous system diseases," and "infectious diseases" where significant unmet medical needs still exist. It also works to develop new medicines utilizing drug delivery system (DDS) technologies, designed to deliver the required amount of a drug in a timely manner to the specific body area. By exploring synergy with in vitro diagnostic devices and reagents owned by Fujifilm group companies, the company will expand its offering of comprehensive solutions from diagnosis to treatment. FUJIFILM Toyama Chemical have expanded its business areas to medical IoT solutions including a system to support pharmacists' drug dispensing auditing work, and a transportation device that enables strict temperature control suited for blood products, cells and tissue used for regenerative medicine. Through the development and supply of high-quality, high added-value new drugs and products that support the clinical settings, FUJIFILM Toyama Chemical strives to solve various social challenges, and contribute to improving medicine and enhancing the quality of life. For more information, please visit http://fftc.fujifilm.co.jp/en/ [http://fftc.fujifilm.co.jp/en/]
About Dr. Reddy's
About Dr. Reddy's: Dr. Reddy's Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy's operates in markets across the globe. Our major markets include - USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com [http://www.drreddys.com/]
AiPHARMA is an early-stage biotechnology company with regional offices in Boston, Dubai, Tokyo, Singapore and Hong Kong. Aipharma take a highly interdisciplinary approach to science, with services building upon work from leading academic labs in biophysics and algorithmic design that enables the acceleration of life science research and development in the pursuit of improved human health. The company leverages machine learning and automation to build platforms for science at scale. With its foundations in engineering disciplines, the company's platform technologies vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials. For more information, log on to: www.aipharmalab.com [http://www.aipharmalab.com/]
Agility is a global logistics company with $5.2 billion in annual revenue and 26,000+ employees in more than 100 countries. It is one of the world's top freight forwarding and contract logistics providers, and a leader and investor in technology to enhance supply chain efficiency. Agility is a pioneer in emerging markets and one of the largest private owners and developers of warehousing and light industrial parks in the Middle East, Africa and Asia. Agility's subsidiary companies offer fuel logistics, airport services, commercial real estate and facilities management, customs digitization, and remote infrastructure services. For more information about Agility, visit www.agility.com [http://www.agility.com/]
Twitter: twitter.com/agility [http://www.twitter.com/agility] LinkedIn: linkedin.com/company/agility [http://www.linkedin.com/company/agility] YouTube: youtube.com/user/agilitycorp [http://www.youtube.com/user/agilitycorp]
Forward Looking Statement -- This news release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from clinical trials involving Avigan® and the possibility that we may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that GRA and Dr. Reddy's may make a strategic decision to discontinue development of Avigan®. As a result, Avigan® may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward- looking statements. These and other risks are described in detail in Dr. Reddy's Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to GRA, and GRA assumes no obligation to update any such forward-looking statements.
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