Pharmaceutical company Zydus Cadila on Monday announced that it has sought the approval of the Drugs Controller General of India for using its hepatitis drug for the treatment of coronavirus. This came after the third phase trials of the Pegylated Interferon Alpha 2b, PegiHep (PegIFN) showed promising results in treating the infection, the company said in a statement.
“In what could be a breakthrough in the disease management of Covid-19, the interim results indicate that PegIFN when administered early on, could help patients recover faster and avoid much of the complications seen in the advanced stages of the disease,” it said. The firm said that the treatment would be less complicated and affordable as it is a single dose regimen.
The results of phase 3 trials conducted on 250 patients across 20-25 centres in India showed that 91.2% of patients treated with the drug were found RT-PCR negative by the seventh day as compared to 78.9% in patients who were given just the standard of care. The term refers to appropriate treatment given to patients for any condition.
The drug, originally approved for use in chronic hepatitis B and C patients, also reduced the duration for supplemental oxygen needed to 56 hours from 84 hours in moderate Covid-19 patients.
The trials results also showed that patients who were given the drug needed lesser amount of supplemental oxygen. This indicates that it was able to control respiratory distress and failure that has been one of the major challenges in treating Covid-19, the company said.
It said that the drug has a well-established history of safety with multiple doses being administered to hepatitis B and C patients for many years. “Aging reduces the body’s ability to produce Interferon Alpha in response to viral infections and may be associated with higher mortality in elderly patients,” the statement said. “Pegylated Interferon Alpha 2b given early during infection can replace this deficiency and aid a faster recovery process.”
Dr Sharvil Patel, managing director of Cadila Healthcare Ltd, said that the company was encouraged by the results of the trial. “With Indian innovation at the forefront helping the country fight the pandemic with diagnostics, vaccines and therapeutics, this marks an important milestone,” he said. “At Zydus, we stand committed to our endeavour of supporting patients and caregivers with access to treatment options that are affordable and can help in better disease management of Covid-19 at different stages.”
The company is also conducting phase 2 trials in Mexico and is in talks with the United States Food and Drug Administration to initiate clinical trials.
Meanwhile, India on Monday recorded 1,03,558 daily coronavirus cases, the most infections reported in a day since the pandemic began. With this, the country’s overall count rose to 1,25,89,067. The country registered 478 additional deaths, taking the toll to 1,65,101.