Pharmaceutical major Zydus Cadila on Monday received approval from Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) to test one of its lead research candidate Desidustat in the management of COVID-19. “Clinical and regulatory development of Desidustat in coronavirus is being executed in Mexico by Avant Sant, Research Center S.A. de C.V., a leading contract research organisation headquartered in Monterrey, Mexico,”
Cadila Healthcare said in a regulatory filing. The company said it will conduct a study to evaluate the efficacy and safety of Desidustat tablets for the management of COVID-19 patients. “As a part of the study, 100 mg tablets of Desidustat will be administered for a period of 14 days along with recommended standard care during the trial,” the company added.
Zydus Cadila Chairman Pankaj R Patel said, “At Zydus, we have been stepping up our efforts to fight the COVID-19 pandemic through therapeutic drugs, diagnostics and vaccines. With Desidustat we will study a novel approach for management of COVID-19″.
Zydus had initiated two phase-III trials of Desidustat. Last week, Zydus had received approval from Indian authorities to start human trials for its COVID-19 vaccine contender – the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide.
Zydus has developed ZyCoV-D at the company’s Vaccine Technology Centre in Ahmedabad. It has now received permission from the Drug Controller General of India (DGCI) – Central Drugs Standard Control Organisation (CDSCO) to initiate phase I/II human clinical trials in India, Cadila Healthcare said in a regulatory filing.
According to Cadila Healthcare, the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs, and rabbits. The antibodies produced by the vaccine were able to completely neutralise the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate, it said.
Meanwhile, shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 363.40 apiece on BSE, 0.78 per cent lower against their previous close.