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India-based Zydus Cadila has secured approval from the Mexican regulatory agency COFEPRIS for clinical studies of its Pegylated Interferon alpha-2b, PegiHep, to treat Covid-19.
This open-label, randomised, comparator controlled study will assess the safety, efficacy and tolerability of PegiHep.
Mexican contract research organisation (CRO) Avant Santé Research Center will be responsible for clinical and regulatory development of the biological therapy in the country.
The company previously received approval from the Drugs Controller General of India (DCGI) to perform clinical trials of Pegylated Interferon alpha-2b. The studies in India are ongoing.
Zydus is also collaborating with the US Food and Drug Administration (FDA) on an investigational new drug (IND) application for the potential treatment.
Cadila Healthcare managing director Dr Sharvil Patel 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 company decided to explore PegiHep as a potential treatment for Covid-19 based on findings from research at Leiden University Medical Center, Netherlands.
These findings indicated a direct anti-viral effect of Pegylated Interferon alpha against SARS-CoV-2. The product was able to completely neutralise the virus in-vitro, according to Zydus.
In separate research by a group of universities across China, Australia and Canada in 77 moderate Covid-19 patients in Wuhan, Interferon alpha-2b was found to significantly decrease the duration of virus shedding period and IL-6 levels.
Since 2011, Zydus has been commercially producing PegiHep to treat hepatitis B and C.
Earlier this month, Zydus received approval from COFEPRIS to assess Desidustat as a potential Covid-19 treatment.
Desidustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability.