Zydus Cadila gets DCGI nod to start phase 3 trials of Covid-19 vaccine on patients
1 min read . Updated: 02 Jan 2021, 08:05 PM IST
Premium- Drug firm Zydus Cadila will conduct the phase 3 clinical trials with its biological therapy 'PegiHep' in Covid-19 patients
Drug firm Zydus Cadila has said that it has received the approval from the Drugs Controller General of India (DCGI) to start the phase 3 clinical trials of the indigenously-developed Covid-19 vaccine on coronavirus patients.
Zydus Cadila will conduct the phase 3 clinical trials with its biological therapy 'PegiHep'. The phase 3 trials of the coronavirus vaccine developed by Zydus Cadila will commence this month.
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The drug firm had completed the phase 2 clinical trials with PegiHep last month.
Zydus Cadila, in a regulatory filing on Friday, has said that it has received approval from the DCGI to start the phase 3 clinical trials in COVID-19 patients with its biological therapy Pegylated Interferon alpha-2b or PegiHep.
Trials to be conducted on 250 patients
The trials, which will commence in December, will be conducted on 250 patients across 20-25 centres in the country, according to the company filing.
Speaking on the matter, Sharvil Patel, Managing Director of Cadila Healthcare Ltd, said, "We are encouraged by the results of phase 2 study of Pegylated Interferon alpha 2-b which has shown the potential to reduce virus titres when given earlier in the disease."
"Our efforts are to look at possible treatment options to fight COVID-19 which are safe, can be administered easily and also reduce the disease burden," he added.
The firm further said that it is conducting a similar phase 2 trial in Mexico and is also working with the US Food and Drug Administration (USFDA) to open an Investigational New Drug (IND) application for PegiHep in order to initiate appropriate clinical trials in America.
With agency inputs
