New Delhi: Drug firm Zydus Cadila on Friday stated it has received the approval from the Drugs Controller General of India (DCGI) to get started phase 3 clinical trials with its biological therapy PegiHep in COVID-19 sufferers.
The firm had completed the phase 2 clinical trials with PegiHep final month.
In a regulatory filing, Zydus Cadila stated it has received approval from the DCGI to get started the phase 3 clinical trials in COVID-19 sufferers with its biological therapy Pegylated Interferon alpha-2b or PegiHep.
The trials, which will commence in December, will be carried out on 250 sufferers across 20-25 centres in India, according to the filing.
Sharvil Patel, Managing Director of Cadila Healthcare Ltd, stated, “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 appear at probable remedy choices to fight COVID-19 which are secure, can be administered simply and also decrease the illness burden”.
Further, the firm stated it is conducting a comparable phase 2 trial in Mexico and is also functioning with the US Food and Drug Administration (USFDA) to open an Investigational New Drug (IND) application for PegiHep in order to initiate proper clinical trials in the US.