Indian pharma company Zydus Cadila has received the Drugs Controller General of India (DCGI) approval to initiate the Phase III clinical trial of its biological therapy, Pegylated Interferon alpha-2b (PegiHep), in Covid-19 patients.
An approved drug, PegiHep is being repurposed to treat Covid-19.
The trials are set to begin this month and will be conducted on 250 patients across 20-25 centres in India.
Early safety, efficacy and tolerability of PegiHep have been established in the Phase II trials.
The study showed that PegiHep demonstrated statistical clinical benefits on the patients suffering from moderate Covid-19 by reducing their viral load helping in better disease management such as decreased duration of oxygen support.
In addition to improving compliance, a single dose therapy will be inexpensive for patients, Zydus noted.
Cadila Healthcare managing director Dr Sharvil Patel said: “We are encouraged by the results of Phase II study of Pegylated Interferon alpha 2-b which has shown the potential to reduce virus titres when given earlier in the disease.
“Our efforts are to look at possible treatment options to fight Covid-19 which are safe, can be administered easily and also reduce the disease burden.”
In a separate development, Bharat Biotech deemed its Covaxin vaccine as safe and efficacious after Indian state Haryana Home Minister Anil Vij tested positive for Covid-19 despite taking the first dose.
Being developed by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR), Covaxin is an indigenous vaccine candidate for Covid-19.
Vij is the first volunteer in the Phase III trials of Covaxin, PTI reported.
The news agency quoted Bharat Biotech as saying: “Covaxin clinical trials are based on a two-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the second dose.”
According to the company, the double-blinded and randomised Phase III trials will be conducted on 26,000 subjects across 25 sites to evaluate the efficacy of Covaxin across the country.
Last month, Bharat Biotech initiated the Phase III human clinical trial of Covaxin at the AIIMS.