Dr. Reddy’s and GRA Announce Clinically Meaningful Data from Avigan Pivotal Studies
Sub-group analysis shows three-day earlier discharge from hospital in low-risk patients hospitalized with COVID-19
KUWAIT – January 27, 2021
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as “Dr. Reddy’s”) and Global Response Aid FZCO (GRA) today announced results from an Avigan study on moderate-severe hospitalized COVID-19 patients in Kuwait.
A sub-group analysis of the low-risk (low NEWS Score at admission) study cohort (n=181) demonstrated a 3 day earlier discharge in Avigan group compared to placebo group (8 days vs 11 days; p=0.0063) for time to hospital discharge secondary endpoint. This endpoint was predefined and showed statistical significance in a large portion of subjects in this study. Time to hospital discharge is the best endpoint to determine if Avigan has a pragmatic effect on patients’ duration of hospitalization, a factor that is relevant to global shortages in clinical resources and hospital beds induced by the global Covid-19 pandemic.
The findings point favorably towards the hypothesis that an antiviral drug like Avigan (or similar oral or injectable RNA polymerases inhibitor) may be effective as part of early treatment initiation in COVID 19 patients.
As a result of the favorable sub-group data, which are supported by similar results in Japan-based clinical trials and real-word studies, Dr.Reddy’s and Global Response Aid have agreed to expedite ongoing Phase 3 pivotal studies aimed at determining the efficacy of Avigan as an early treatment for COVID-19 patients with mild-to-moderate symptoms. Additional studies to evaluate the efficacy of Avigan as part of early treatment in COVID 19 patients have also been initiated, with the goal of alleviating symptoms and preventing disease progression before the infection requires hospitalization or other intensive interventions.
Other findings from the study of hospitalized patients with moderate-severe COVID 19 patients showed a one-day reduction in time to sustained hypoxia resolution for Avigan vs. placebo. Resolution occurred in seven days vs. eight days. However, the study did not achieve statistical significance thresholds, and was terminated. The full final data analysis of the 353 subjects who were part of the study of hospitalized patients will be available by end of February 2021.
The study of hospitalized patients was part of an overall clinical program for Avigan in Kuwait, which covered a spectrum of COVID-19 cases ranging from asymptomatic to severe, in both outpatient and in-patient settings.
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.VISIT DR. REDDY'S
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.VISIT GLOBAL RESPONSE AID
About Avigan (Favipiravir)
Avigan (Favipiravir) an influenza anti-viral developed by FujiFilm, comes in tablet and IV form and is approved in a number of countries as a therapeutic to reduce the severity of COVID-19 symptoms and speed the recovery of patients diagnosed with the virus. Data is emerging from multiple clinical studies indicating its effectiveness in the treatment of mild to moderate COVID-19 patients. Therefore, it could serve a first line of treatment in patients long before severe symptoms set in, reducing the need for hospitalization.
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.