Zydus receives approval from Mexican drug regulator to conduct clinical trials with Pegylated Interferon alpha-2b to treat COVID-19

Biznextindia : Pharmaceutical major Zydus Cadila on Friday announced that it had received approval from the Mexican regulatory authority COFEPRIS to conduct clinical trials with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHepTM’. This will be an open-label, randomized, comparator-controlled study of Pegylated IFN alfa-2b to evaluate safety, efficacy and tolerability in patients with COVID-19.

Clinical and regulatory development of Pegylated Interferon alpha-2b in COVID-19 is being executed in Mexico by Avant Santé Research Center S.A. de C.V., a leading Contract Research Organization (CRO) headquartered in Monterrey, Mexico.

Zydus had earlier approached the DCGI to investigate the role of Pegylated Interferon alpha-2b for COVID 19 and the clinical trials are now underway. The Company is also working with USFDA to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b.

“Our endeavour is to continue looking for pathways for a safe and efficacious treatment to combat COVID 19. Pegylated Interferon-alpha has the potential to reduce virus titres when given earlier in the disease. The focus is on reducing the viral load and generating virus eliminating specific immune response” said Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd.

How Interferon Alpha 2b works

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 the viral replication but also helps activate the two arms of our immune system – Innate, for the immediate killing of the virus and Adaptive, for long-lasting immunity. To make it more effective, the molecule is coupled with polyethene glycol to produce a new molecule called, Pegylated Interferon-alpha, that has the same functionality as Interferon-alpha but remains in the body longer and therefore requires only once-a-week injection, thus providing a much better efficacy profile. Zydus has been commercially manufacturing Pegylated Interferon alpha-2b under the brand name, PegiHepTM, since 2011 for the treatment of Hepatitis B and C with 1.5 lac doses being administered. PegiHepTM is not yet licensed or approved for the treatment of COVID-19.