Ahmedabad-based Zydus Cadila has successfully completed Phase II clinical trials of its biological therapy Pegylated Interferon alpha-2b, named PegiHep, in COVID-19 patients. In a study involving 40 adult patients with moderate COVID-19 disease, 95 per cent subjects who received a single dose of PegiHep along with the Standard Of Care (SOC) became virus free as assessed by RT-PCR on day 14, said Zydus Cadila. Based upon the results from its Phase II study, Zydus Cadila now plans to conduct Phase III clinical trials in India.
Zydus Cadila is also conducting a similar Phase II trial in Mexico. The company is also working with the USFDA to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in US. Zydus Cadila had conducted this study on the approval from the Drug Controller General of India (DCGI) to investigate the role of Pegylated Interferon alpha-2b for COVID-19.
Pegylated Interferon alpha-2b was first approved internationally in 2001 and is also included in WHO's Essential Medicines List. Zydus Cadila's Pegylated Interferon alpha-2b, PegiHep, was originally approved for Hepatitis C and was launched in the Indian market in 2011. The drug was repurposed for treating moderate COVID-19 patients. In 19 out of 20 patients, a single 1 mcg/kg dose of the drug demonstrated viral clearance as assessed by RT-PCR and a significant improvement in clinical symptoms, said Zydus.
Clinical improvement was assessed using a seven-point ordinal scale where the patients were assessed on multiple criteria such as requirement and duration of hospitalisation, ventilation, supplemental oxygen, etc. The study established the early safety, efficacy and tolerability of PegiHep in moderate COVID-19 patients. The study so far has indicated that Pegylated Interferon alpha-2b could have a beneficial impact on the patient suffering from moderate COVID-19 disease by reducing their viral load helping in better disease management such as reduced duration of oxygen support. Moreover, a single dose therapy will improve compliance and also make it highly affordable for patients.
"We continue to look at possible treatment options that are safe and efficacious in the treatment and management of COVID-19. Pegylated Interferon alpha-2b has shown the potential to reduce virus titres when given earlier in the disease and we will like to explore this biological option further. We are hopeful of reinforcing our treatment options to fight COVID-19," said Dr Sharvil Patel, Managing Director, Cadila Healthcare (Zydus Cadila).
Zydus is also developing two vaccines and a new chemical entity to treat COVID-19.