AsiaNet 87810

KUWAIT CITY, Jan. 28, 2021 /PRNewswire=KYODO JBN/ --

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