Zydus receives Mexican regulatory approval to conduct clinical trials with Pegylated Interferon alpha-2b

For treatement of COVID-19

Zydus Cadila 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 SantResearch 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, 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.

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.

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