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Covid-19: Zydus Cadila gets the go-ahead from DGCI for phase 3 clinical trials with biological therapy | India News


NEW DELHI: Pharmaceutical firm Zydus Cadila said on Friday that it received approval from the Comptroller General of Medicines of India (DCGI) to begin phase 3 clinical trials with its PegiHep biological therapy in Covid-19 patients.
The company had completed phase 2 clinical trials with PegiHep last month.
In a regulatory filing, Zydus Cadila said that he received approval from the DCGI to begin phase 3 clinical trials in Covid-19 patients with their Pegylated Interferon alfa-2b or PegiHep biological therapy.
The trials, which will begin in December, will be carried out on 250 patients at 20-25 centers in India, according to the presentation.
Sharvil Patel, Managing Director of Cadila Healthcare Ltd, said: “We are encouraged by the results of the phase 2 study of pegylated interferon alfa 2-b, which has shown the potential to reduce virus titers when administered earlier in the disease.
“Our efforts are to look for possible treatment options to combat Covid-19 that are safe, can be easily administered, and also reduce the burden of the disease.”
Additionally, the company said it is conducting a similar phase 2 trial in Mexico and is also working with the United States Food and Drug Administration (USFDA) to open an Investigational New Drug (IND) application for PegiHep. in order to initiate appropriate clinical trials in the country. US.

Times of India