Zydus Cadila receives DCGI approval to start Phase 3 clinical trial of Pegylated Interferon Alpha-2b
Zydus Cadila announced that its Phase III clinical trials with Pegylated Interferon Alpha 2b, PegiHepTM has shown promising results in treating 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 avoiding much of the complications seen in the advanced stages of the disease. PegIFN in COVID19 has several add-on advantages compared to other anti-viral 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 very well-established safety with multiple doses in chronic hepatitis B and C patients since many years. Patients on Pegylated Interferon Alpha 2b during the trial 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 (Lu et al, Signal Transduction and Targeted Therapy (2021) 6:107, a Nature publication. With these positive results, the Company has applied for an approval for additional indication with the DCGI for the use of PegIFN in the treatment of COVID 19.
91.15% of patients treated with PegIFN were RT PCR negative by day 7 as compared to 78.90% 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.
A single dose of PegIFN administered early on shows high clinical improvement in patients.
Findings are in line with the research papers published in internationally reputed publications - Nature and Science.
Powered by Capital Market - Live News
(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)