Pharma firm seeks approval to conduct clinical trials of its hepatitis medicine
NEW DELHI: Zydus Cadila has sought permission from India’s drugs controller to conduct clinical trials to test the efficacy of its antiviral hepatitis medicine to treat adults affected by the coronavirus disease (Covid-19).
The medicine, called Pegylated Interferon alpha-2b, is used to treat viral hepatitis B and C, and other viral liver infections. Interferon has been used in the treatment of Covid-19 in China and Cuba, and is a part of the treatment guidelines of the Chinese government.
In a statement, the company contended that its biological therapy, Pegylated Interferon alpha-2b, sold under the trade name PegiHepTM, could emerge as one of the pathways to treat Covid-19 as it has shown to reduce viral load and generate virus eliminating specific immune response in past studies.
“The central drugs control department has received an application from them, and it is being considered. However, there has not been any decision taken over it yet,” said a senior official in the Union health ministry who asked not to be named.
“We are working with the US Food and Drug Administration (FDA) and have opened an investigational new drug (IND) filing for Pegylated Interferon alpha-2b for the treatment of Covid-19. We are also working with the Department of Biotechnology to investigate the role of Pegylated Interferon alpha-2b for Covid-19 and are planning to undertake clinical trials for this,” Sharvil Patel, managing director, Cadila Healthcare Ltd added in the statement.
When the human body contracts an infection due to a viral attack, it produces a group of molecules called Type 1 interferons as a first line of defence.
Interferon alpha is one such Type 1 interferon molecule that not only slows down viral replication but also helps activate the two arms of the human immune system: innate, for immediate killing of the virus; and adaptive, for long-lasting immunity. In some studies in the US and China, the medicine has shown to improve the condition of patients.