Zydus gets Mexican regulator nod to conduct clinical trials with Pegylated Interferon alpha-2b to treat COVID-19
Jul 17, 2020
Ahmedabad (Gujarat) [India], July 17 : Pharmaceutical major Zydus said on Friday it has got approval from Mexico's Federal Commission for the Protection against Sanitary Risk (COFEPRIS) to conduct clinical trials with its biological therapy 'Pegylated Interferon alpha-2b' for the treatment of COVID-19.
"This will be an open-label, randomised, comparator controlled study of Pegylated IFN alfa-2b to evaluate safety, efficacy and tolerability in patients with COVID-19," it said in a statement.
Clinical and regulatory development of Pegylated Interferon alpha-2b in COVID-19 is being executed in Mexico by Avant Sante Research Centre SA de CV, a leading contract research organisation headquartered in Monterrey.
Zydus had earlier approached the Drug Controller General of India (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 the US Food and Drug Administration to open an investigational new drug application for Pegylated Interferon alpha-2b.
"Our endeavour is to continue looking for pathways for a safe and efficacious treatment to combat COVID-19," said Sharvil Patel, Managing Director of Cadila Healthcare Ltd.
"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," he said.
