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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

Coronavirus | Zydus Cadila | Coronavirus Tests

Vinay Umarji  |  Ahmedabad 

Coronavirus, vaccine, covid, drugs, clinical trials
The therapy was found to have significantly increased viral reduction and reduced the need for supplemental oxygen in moderate Covid-19 patients

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, 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.

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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, 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.

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First Published: Fri, December 04 2020. 20:23 IST