Zydus Cadila Gets DGCI Approval For Phase Three Clinical Trials With Biological Therapy
New Delhi: Drug firm Zydus Cadila has received 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 New Indian Express (TNIE) reported.
The company had completed phase 2 clinical trials with PegiHep last month.
The trials, to begin this month, will be conducted on 250 patients across 20-25 centres in India, the report added.
“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,” Sharvil Patel, Managing Director of Cadila Healthcare Ltd was quoted as saying.
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 to initiate appropriate clinical trials in the US, the report added.