Zydus Cadila gets DGCI nod for phase 3 clinical trials with biological therapy

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 the 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 centres in India, according to the filing.

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”.

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.