Monday, January 25, 2021 3:41:55 PM
https://www.business-standard.com/article/companies/dr-reddy-s-zuventus-get-nod-to-conduct-covid-19-trials-on-repurposed-drugs-121012501695_1.html
The subject expert committee (SEC) has given the go-ahead to a clutch of firms, including Dr Reddy’s Laboratories (DRL) and Zuventus Healthcare, to conduct clinical trials on repurposed drugs for Covid-19.
Mumbai’s Zuventus and Hyderabad’s DRL have got the nod to conduct Phase 3 clinical trials of Aviptadil injectable formulation. Aviptadil — a vasoactive intestinal polypetide used to treat erectile dysfunction — has been found to be useful in treating respiratory distress in Covid-19 patients. The US Food and Drug Administration has allowed emergency-use of the drug for treating Covid-19 patients.
NeuroRx and Relief Therapeutics have partnered to develop a drug called RLF-100 that has anti-inflammatory and anti-cytokine activity properties.
The SEC noted that Zuventus had presented revised Phase 3 clinical trial protocol before the committee, and after “detailed deliberation”, it recommended grant of permission of Phase 3 trials with the drug, “subject to condition that criteria for discharge of patients from intensive care unit should be defined clearly in the protocol”.
As for DRL, the SEC has noted that the trial should be termed Phase 3 clinical trial instead of Phase 2/3 trial.
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