Zydus Cadila to conduct COVID-19 trials in Mexico with its biological therapy 'PegiHepTM'

On Friday, Zydus Cadila announced that it has received approval from Mexican regulatory authority, COFEPRIS, to conduct clinical trials with its biological therapy, Pegylated Interferon alpha-2b, 'PegiHepTM'. The trials are scheduled to begin in July 2020. They will be open-label, randomized ad comparator-controlled to evaluate safety, efficacy and tolerability in patients with COVID-19.

Recent research shows that Interferon-alpha significantly reduces Coronavirus concentration in vitro studies. A clinical study in China has even showed a shortened duration of viral shedding in patients.

Earlier, Zydus had approached Drug Controller General of India (DCGI) to investigate the role of Pegylated Interferon alpha-2b for COVID-19 and now the clinical trials are underway in India. Additionally, the company is working with United States Food and Drug Administration (USFDA) to open an Investigational New Drug (IND) application for the biological therapy.

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 lakh administered doses. However, it has not yet been licensed or approved for the treatment of COVID-19.

Dr Sharvil Patel, Managing Director at Zydus Healthcare, while speaking on the development stated that Pegylated Interferon alpha has the potential to reduce virus concentration when given earlier in the disease and thus, the focus is on reducing the viral load and generating virus eliminating specific immune response.

At 10 a.m. on Friday, Zydus Healthcare's stock was trading at Rs 366.50, up by 1.54 per cent or Rs 5.55 per share. The 52-week high is Rs 383.65 and the 52-week low is recorded at Rs 206.45 on BSE.