Pharmaceutical company Zydus Cadila said on Thursday
he has successfully completed a Phase 2 clinical trial in COVID-19 patients with his biologic therapy, “PegiHep”, and will now begin a Phase 3 clinical trial.
In a regulatory filing, Zydus Cadila said “it has successfully completed a Phase 2 clinical trial in COVID-19 patients with its biologic therapy, pegylated interferon alpha-2b, ‘PegiHep’ … Based on the results of its phase 2 study, Zydus Cadila now plans to conduct a phase 3 clinical trial in India “.
Zydus Cadila, who is part of the Cadila Healthcare group, said that pegylated interferon alpha 2b significantly increases viral reduction and reduces the need for supplemental oxygen in moderate COVID-19 patients.
“We continue to examine possible treatment options that are safe and effective in the treatment and management of COVID-19. Pegylated interferon alpha-2b has shown the potential to reduce virus titers when given earlier in disease and we would like to explore this biological option. We hope to strengthen our treatment options to fight COVID-19, ”said Sharvil Patel, Managing Director of Cadila Healthcare Ltd.
Pegylated interferon alpha-2b is not a new therapy. The product was first approved internationally in 2001 and is also included in the WHO Essential Medicines List.
Zydus Cadila said his pegylated alpha-2b interferon, PegiHep, was initially approved for hepatitis C and was launched in the Indian market in 2011.
Since then, the safe and effective use of the drug for this product has been demonstrated in thousands of patients, the company added.
Zydus Cadila said he conducted this study on the Drugs Controller General of India (DCGI) approval to investigate the role of pegylated interferon alpha-2b for COVID 19. The company is also conducting a similar Phase 2 trial in Mexico. .
The company is also working with the United States Food and Drug Administration (USFDA) to open an Investigational New Drug Application (IND) for pegylated interferon alpha-2b to initiate appropriate clinical trials in the United States.
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