With the phase-3 clinical trials of its Pegylated Interferon Alpha 2b therapy, PegiHep, showing promising results, Cadila Healthcare Ltd (Zydus Cadila) has applied for an approval for additional indication with the Drugs Controller General of India (DCGI) for the use of PegIFN in the treatment of Covid-19.
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.
According to Zydus Cadila, PegIFN in Covid-19 has several add-on advantages compared to other anti-viral agents with the treatment regimen being less cumbersome and more affordable for patients as Pegylated Interferon Alpha 2b, is a single dose regimen.
Over the years, PegIFN has had very well-established safety with multiple doses in chronic hepatitis B and C patients. During the clinical trials, patients on Pegylated Interferon Alpha 2b also showed lesser need for supplemental oxygen, clearly indicating that it was able to control respiratory distress and failure which has been one of the major challenges in treating Covid-19. The findings are in line with recently reported importance of early IFN treatment given in combination with steroids in the treatment of Covid-19.
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. However, when given early during infection Zydus Cadila's Pegylated Interferon Alpha 2b can replace this deficiency and aid a faster recovery process.
The Phase III trials were conducted on 250 patients across 20-25 centres in India and the detailed results of this will be published in a peer-reviewed scientific journal.
"We are encouraged by the results of the Phase III study of Pegylated Interferon alpha 2b which has confirmed the potential to reduce virus titres when given earlier in the disease. With Indian Innovation at the forefront helping the country fight the pandemic with diagnostics, vaccines and therapeutics, this marks an important milestone," said Sharvil Patel, Managing Director, Cadila Healthcare Ltd.
Meanwhile, besides conducting a phase two trial in Mexico, the company is also working with the USFDA for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in the US.