Zydus Cadila, announced that it has 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.
According to the Company’s press statement, 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.
Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, “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.”
The treatment option emerged after the publication of two recent peer reviewed research articles. The first one by Ogando et al (Journal of General Virology, June 2020) at Leiden University Medical Center, Netherlands showed evidence of a direct anti-viral effect of Pegylated Interferon alpha against novel Coronavirus. The study demonstrated that Pegylated Interferon was able to completely neutralize SARSCoV-2 virus in vitro. The second by Zhou et al (Frontiers in Immunology, May 2020) from a group of universities in China, Australia and Canada retrospectively analysed 77 moderate COVID-19 subjects in Wuhan and observed that those who received Interferon alpha-2b showed a significant reduction in the duration of virus shedding period and even in levels of the inflammatory cytokine, IL-6.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines. The group employs nearly 25,000 people worldwide, including 1,400 scientists engaged in R&D, and is dedicated to creating healthier communities globally.
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