Anti-Viral Backed by GRA on Track to Deliver Home Treatment for COVID-19 by Summer 2021
Pivotal Phase 3 clinical trial is on track after interim results analysis
DUBAI – May 17, 2021 – Healthcare solutions provider Global Response Aid (GRA) announced that a Phase 3 U.S.-Canada clinical trial of anti-viral Avigan® (Reeqonus™) will continue amid signs the drug could be effective in the treatment of patients with mild to moderate cases of COVID-19.
An independent Data and Safety Monitoring Board (DSMB) recognized by the U.S. Food and Drug Administration has recommended continuation without modification of an ongoing Phase 3 PRESECO (PREventing SEvere COvid-19) trial that is evaluating Avigan® as a potential outpatient oral therapy for patients with mild-to-moderate COVID-19.
Interim results indicate that Avigan®, the brand name for generic Favipiravir, could shorten recovery times and prevent progression in COVID-19 patients in the early stage of infection. The conclusion of the midterm analysis is that, if current trends continue, the required statistically measured threshold for efficacy can be met at the completion of the study. GRA and study co-sponsors Appili Therapeutics will continue the current PRESECO trial, which is expected to enroll its last patient on June 30.
The U.S.-Canada PRESECO trial is investigating whether Avigan® can safely and effectively shorten recovery times in early-onset COVID-19 cases and shorten the duration of patient viral loads, lowering the propensity of the virus to spread.
Together with Indian life sciences leader Dr. Reddy’s, Dubai-based GRA owns the rights to manufacture, market and distribute Avigan® outside of Japan ,China and Russia. GRA sponsored the trial in collaboration with Appili Therapeutics, a Canadian biopharmaceutical company specializing in development of drugs for infectious diseases.
Dr. Richard Kaszynski, one of the leading experts on Favipiravir, said: “The efficacy signals and safety profile observed thus far appear encouraging. The implications of this study are global, and it would be prudent to steadfastly maintain the current momentum through full enrollment in order to rapidly determine whether statistically significant endpoints can be achieved. The establishment of an early outpatient treatment that could concomitantly serve as a novel strategy to prevent onward viral transmission is an exciting and noteworthy endeavor.”
Mitch Wilson, CEO of GRA, said: “We are confident we are on track for delivering a home treatment for COVID-19 by summer this year, subject to regulatory approvals. The global rollout of COVID-19 vaccines, while welcome, won’t eliminate the need for effective treatment of infected patients. We know that we will need more in our COVID-fighting arsenal. We know we will need the ability to treat people who get the virus because they haven’t been vaccinated or who become infected despite having received vaccines. Avigan® could be a powerful tool because it is a relatively inexpensive, oral medication that comes in tablet form and can be prescribed early to prevent hospitalization.”
Favipiravir was developed by FujiFilm Toyama Chemical as an anti-viral for novel or re-emerging influenzas. In 2020, GRA and Dr. Reddy’s signed an agreement with FujiFilm Toyama Chemical for global commercialization of the drug outside Japan, China and Russia.
In its branded and generic forms, it has been used to treat more than 400,000 patients. The drug is available in tablet form for outpatient and inpatient use, and is stable and easy to transport without need for refrigeration. It has a shelf life of ten years.
About Global Response Aid (GRA)
Agility (KSE/DFM: AGLTY), one of the world’s leading logistics companies and AiPharma, 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 Appili Therapeutics
Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan® (favipiravir) for the worldwide treatment and prevention of COVID-19. The Company is also advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.appilitherapeutics.com
About Dr. Reddy’s
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) 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: www.drreddys.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