Zydus gets DCGI approval for phase-3 clinical trials of Covid-19 therapy

Trials will involve use of Cadila's biological therapy Pegylated Interferon alpha-2b in India

Cadila Healthcare Ltd (Zydus Cadila) has obtained approval from the Drugs Controller General of India (DCGI) to start the phase-3 clinical trial on Covid-19 patients with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHepTM’.

Last month, Zydus Cadila had announced "successful" completion of phase two clinical trial of the biological therapy on Covid-19 patients, paving way for phase three trials in India. Cadila had stated that the open-label, randomized, comparator controlled study was conducted on 40 adult patients with moderate Covid-19 disease.

Of these, 95 per cent subjects in the test who received a single dose of PegiHepTM along with standard of care (SOC) became virus free as assessed by RT-PCR on day 14, compared to only 68 per cent those who only received SOC becoming RT-PCR negative.

The therapy was found to have significantly increased viral reduction and reduced the need for supplemental oxygen in moderate Covid-19 patients. 

Speaking on the development, Sharvil Patel, Managing Director, Cadila Healthcare Ltd, 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 the test arm 16 subjects were RT-PCR negative as early as day seven of treatment which was an improvement over the reference arm. 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 and supplemental oxygen, among other things.

Meanwhile, Zydus Cadila is also conducting a similar Phase-2 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.