Ahmedabad: Pharmaceutical major Zydus Cadila said on Monday it has got approval from Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) for its one of its lead research candidate Desidustat to be tested in the management of COVID-19.
The clinical and regulatory development of Desidustat in COVID-19 is being executed in Mexico by Avant Sante Research Centre, a leading contract research organisation headquartered in Monterrey.
“The company will be conducting a phase 2b, multi-centre, open-label, randomised, comparator-controlled study to evaluate the efficacy and safety of Desidustat tablet for the management of Covid-19 patients,” said Zydus in a statement.
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.
Patients infected with COVID-19 have been reported to display signs of hypoxia, leading to organ failure and death despite the use of anti-virals, anti-inflammatory drugs or ventilators.
Zydus said the attack with the novel coronavirus pneumonia (COVID-19) will cause less and less haemoglobin that can carry oxygen and carbon dioxide. The lung cells have been reported to develop extremely intense poisoning and inflammation due to the inability to exchange carbon dioxide and oxygen frequently, which eventually results in ground-glass-like lung images.
Desidustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor which is currently undergoing phase three trials, mimics the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilisation of hypoxia-inducible factor, and this can lead to increased red blood cell production and improved oxygen delivery to tissues.
“At Zydus, we have been stepping up our efforts to fight the COVID-19 pandemic through therapeutic drugs, diagnostics and vaccines,” said Chairman Pankaj R Patel. “With Desidustat, we will study a novel approach for the management of COVID-19,” he added.
At 10:50 am, the company’s stock was trading 2.2 per cent higher at Rs 1,357 per unit.