Zydus Cadila receives DCGI approval to start Phase 3 clinical trial of Pegylated Interferon Alpha-2b

Zydus Cadila announced that it had received an approval from the Drugs Controller General of India (DCGI) to start the Phase 3 clinical trial in CoVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, 'PegiHep™ '. The trials which will commence in December will be conducted on 250 patients across 20-25 centres in India.

In the Phase II clinical trials study established the early safety, efficacy and tolerability of PegiHep™ and has indicated that Pegylated Interferon alpha-2b having statistical clinical beneficial impact on the patient suffering from moderate COVID 19 disease by reducing their viral load helping in better disease management such as reduced duration of oxygen support. Moreover, a single dose therapy will improve compliance and also make it highly affordable for patients. Pegylated Interferon alpha-2b, 'PegiHep™ is an approved drug and is being re-purposed for the treatment of COVID-19.

 

Zydus Cadila is also conducting a Phase 2 trial in Mexico. The Company is also working with the USFDA to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in US.

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