Dr Reddy’s Laboratories and Global Response Aid (GRA) on January 27 announced the termination of Avigan (favipiravir) clinical trial conducted in Kuwait on moderate to severe COVID-19 patients in a hospital setting, as the data failed to show a statistically significant difference for the primary endpoint.
The data from the Kuwait study involving moderate-severe COVID-19 hospitalised patients did not show a statistically significant difference for the primary endpoint or the time taken to resolve hypoxia. However, low-risk category COVID-19 patients on the broad spectrum antiviral got discharged three days ahead of the placebo group.
GRA is an alliance focused on improving medical supply chain worldwide. Hypoxia is a condition in which the body is deprived of adequate oxygen supply. Hypoxia is the major symptom in patients with moderate-severe COVID-19.
While it took seven days or a day less than placebo for resolution of hypoxia in the Avigan arm.
Dr Reddy's said the full data analysis on 353 subjects would be available by the end of February 2021.
The drugmaker said a sub-group analysis carried out on 181 subjects in the low-risk category had shown patients on Avigan getting discharged three days ahead of the placebo group.
"The sub-group analysis of the low-risk study cohort (n=181) demonstrated a 3 day earlier discharge in Avigan group compared to a placebo group (8 days vs 11 days; p=0.0063) for time to hospital discharge secondary endpoint," Dr Reddy's said in a statement.
"The subgroup analysis data during the initial interim analysis points towards the hypothesis with clinically significant insights from this study that an antiviral drug like Avigan may be effective as part of early treatment initiation in COVID 19 patients and not effective in the late-stage hospital treatment for moderate and severe COVID 19 patients," Dr Reddy's added.
The hospitalised patient study, conducted in Kuwait, on moderate to severe patients was one of the studies in the overall clinical program for Avigan, spanning the spectrum of asymptomatic to severe cases of COVID-19 in both outpatient and in-patient setting.
Dr Reddy's said the Phase-III study, being conducted in an outpatient setting on patients with mild to moderate symptoms in North America in partnership with Appili Therapuetics and Global Response Aid, will continue.
Dr Reddy's last year entered into a three-way deal with Japanese drugmaker Fujifilm and Dubai-based Global Response Aid to manufacture and sell its flu drug Avigan (favipiravir) for the potential treatment of COVID-19,
Favipiravir was approved in India for restricted emergency use on patients with low to moderate COVID-19. Dr Reddy's along with over dozen companies have launched are selling the drug in India.