Zydus' COVID-19 drug shows promise in Phase 3 trials; seeks DCGI nod

Zydus Cadila announced on Monday, April 5 that it has sought approval from drug regulator DCGI (Drugs Controller General of India) for its drug Pegylated Interferon Alpha 2b (PegIFN) to be used in the treatment of COVID-19 patients. The domestic pharma company has applied for an approval for additional indication with DCGI for the use of PegIFN, announcing that its phase-III clinical trials with the drug have manifested promising results in treating coronavirus patients.

Over 91.15% of patients treated with PegIFN were RT PCR negative by day 7 as compared to 78.90 per cent on the 'standard of care' (SOC) arm; PegIFN reduced the duration for supplemental oxygen to 56 hours from 84 hours in moderate COVID-19 patients

In what could be a breakthrough in the disease management of COVID-19, the interim results show PegIFN, when administered early on, could help patients recover faster, avoiding complications seen in the advanced stages.

"PegIFN in COVID19 has several add-on advantages compared to other antiviral agents. The treatment regimen would be less cumbersome and more affordable for patients as Pegylated Interferon Alpha 2b, is a single-dose regimen. It would also ensure better compliance. PegIFN has had very well-established safety with multiple doses in chronic hepatitis B and C patients for many years," Zydus said.

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During the phase 3 trials, patients also showed a lesser need for supplemental oxygen, which shows the drug was able to control respiratory distress and failure, a major challenge in treating COVID-19.

"Pegylated Interferon Alpha 2b therapy has been very well-established with multiple doses being administered in chronic hepatitis B and C patients for many years. Type I interferons, including Interferon-alpha, have been found crucial in the protection against SARS-CoV-2 in the recent publications in the leading journal Science (Hadjadj et al, Bastard et al and Zhang et al)," the company said.

Ageing reduces the body's ability to produce Interferon Alpha in response to viral infections and may be associated with higher mortality in elderly patients. PegIFN given early during infection 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," Dr Sharvil Patel, Managing Director, Cadila Healthcare Ltd, said.

Besides conducting a Phase-II trial in Mexico, the company is also working with the USFDA for Pegylated Interferon to initiate appropriate clinical trials in the US.

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