Cadila Healthcare Ltd., also known as Zydus Cadila, on Thursday announced "successful" completion of phase two clinical trial of its biological therapy Pegylated Interferon alpha-2b, ‘PegiHepTM’ on Covid-19 patients.
In what now paves the way for phase three trials in India, Cadila said 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 company had earlier stated that it was working on Covid-19 vaccine candidate ZyCov-D where Cadila Healthcare hoped to start phase III trials by December. The company is reportedly setting up a production facility with a capacity to make 100 million ZyCov-D doses per year for supply to India, apart from six approaches to treat Covid-19.
According to Cadila Healthcare, the study 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. It further stated that a single dose therapy would improve compliance as well as make it affordable for patients.
Commenting on the development, Sharvil Patel, managing director, Cadila Healthcare Ltd. said, "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."
First approved internationally in 2001 and included in WHO’s essential medicines list, PegiHep therapy was originally approved for Hepatitis C and launched in the Indian market in 2011.
Based upon the phase two study results, the company now plans to conduct a phase three clinical trial in India, in addition to a similar phase two trial in Mexico, apart from seeking USFDA permission to open an Investigational New Drug (IND) application to initiate appropriate clinical trials in the US.
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