Drug firm Zydus Cadila on Friday said it has received the approval from the Drugs Controller General of India (DCGI) to start phase 3 clinical trials with its biological therapy PegiHep in Covid-19 patients.
The company had completed phase 2 clinical trials with PegiHep last month.
In a regulatory filing, Zydus Cadila said 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.
The trials, which will commence in December, will be conducted on 250 patients across 20-25 centers in India, according to the filing.
Zydus Cadila initiated Phase–1 and 2 trials in July. The company has taken a novel approach to its potential Covid-19 vaccine, using the DNA route i.e the vaccine doesn’t use any live virus.
The DNA vaccine consists of the genetic material of SARS-CoV-2 proteins. The genetic material instructs human cells to make SARS-CoV2 antigen, eliciting an immune response.
Prime Minister Narendra Modi on Saturday visited pharma major Zydus Cadila’s manufacturing facility near Ahmedabad, as he began his three-city visit to review ongoing coronavirus vaccine development work.
#WATCH Prime Minister Narendra Modi visits Zydus Biotech Park in Ahmedabad, reviews the development of #COVID19 vaccine candidate ZyCOV-D pic.twitter.com/vEhtNMf1YE
— ANI (@ANI) November 28, 2020
Wearing a PPE kit, Modi reviewed the vaccine development process at the Zydus Cadila research center in Changodar industrial area, over 20 km from Ahmedabad.
Zydus Cadila chairman Pankaj Patel recently said the company is aiming to complete the vaccine trial by March 2021 and could produce up to 100 million doses a year.
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 titers 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”.
Further, the company said 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 the US.