In a regulatory filing, Zydus Cadila said “it has successfully completed a phase 2 clinical trial in COVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHep’… Based upon the results from its Phase 2 study, Zydus Cadila now plans to conduct a phase 3 clinical trial in India”.
Zydus Cadila, which is a part of the Cadila Healthcare group, said Pegylated Interferon alpha 2b significantly increased viral reduction and reduced the need for supplemental oxygen in moderate COVID-19 patients.
“We continue to look at possible treatment options that are safe and efficacious in the treatment and management of COVID-19. Pegylated Interferon alpha-2b has shown the potential to reduce virus titres when given earlier in the disease and we will like to explore this biological option further. We are hopeful of reinforcing our treatment options to fight COVID-19,” Sharvil Patel, Managing Director, Cadila Healthcare Ltd said.
Pegylated Interferon alpha-2b is not a new therapy. The product was first approved internationally in 2001 and is also included in WHO’s Essential Medicines List.
Zydus Cadila said its Pegylated Interferon alpha-2b, PegiHep, was originally approved for Hepatitis C and was launched in the Indian market in 2011.
Since then safe and efficacious drug use for this product has been demonstrated in thousands of patients, the company added.
Zydus Cadila said it had conducted this study on the approval from the Drugs Controller General of India (DCGI) to investigate the role of Pegylated Interferon alpha-2b for COVID 19. The company is also conducting a similar phase 2 trial in Mexico.
The company is also working with the US Food and Drug Administration (USFDA) to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in the US.