Zydus gets nod for conducting phase III clinical trials of its much-awaited COVID vaccine
Zydus Cadila today announced that it has received permission to start the phase III clinical trials in the COVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHepTM’ from Drugs Controller General of India (DCGI). The trials will be conducted on 250 patients across 20-25 centres in India, starting in December.
The phase II clinical trials were open-label, randomised comparator control studies and included a total of 40 adult patients with moderate COVID-19 disease. It showed a very promising result with 95 per cent of the subjects in the test arm, receiving only one dose (1 mcg/kg body weight) of PegiHepTM along with the standard of care (SOC), who became completely virus free on the fourteenth day as accessed by the RT-PCR.
Apart from this, they also showed a statistically significant clinical improvement over the patients in the reference arm, who received only the SOC, where only 68 per cent of the patients showed an improvement in clinical symptoms becoming RT-PCR negative. In the test arm, 16 of the subjects were cured on the seventh day, showing an improvement over the reference arm.
Zydus Cadila is also conducting phase II trials in Mexico and is working with USFDA in order to initiate appropriate clinical trials in the US.
At 2.10 pm today, the stock of Cadila Healthcare Ltd was trading at Rs 475; a 2.64 per cent increase from its previous close of Rs 462.80 on BSE.