Country for PR: United Kingdom
Contributor: PR Newswire Europe
Thursday, January 28 2021 - 06:55
AsiaNet
Dr. Reddy's and GRA Announce Clinically Meaningful Data from Avigan Pivotal Studies
KUWAIT CITY, Jan. 28, 2021 /PRNewswire-AsiaNet/ --

Sub-group analysis shows three-day earlier discharge from hospital in low-risk 
patients hospitalized with COVID-19 

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-world 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 Global Response Aid (GRA) 

Agility (KSE/DFM: AGLTY), one of the world's leading logistics companies, 
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 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  

Source: GRA and Agility
Translations

Japanese