In June 2020, Mexico's regulatory authority had given Zydus Cadila permission to test Desidustat on Covid patients. It said Desidustat showing the potential to help prevent acute respiratory distress syndrome in COVID-19 patients.
Zydus Cadila confirmed on Monday that it has completed the Phase II study of Desidustat in COVID-19 patients in Mexico and has received positive results from it.
In June 2020, Mexico's regulatory authority had given Zydus Cadila permission to test Desidustat on Covid patients. Desidustat is a drug for the treatment of anemia of chronic kidney disease.
Zydus Cadila, which is part of Cadila Healthcare, said in its regulatory filing: "Patients infected with COVID-19 have been reported to display signs of 'Hypoxia' leading to organ failure and death despite the use of antivirals, anti-inflammatory drugs or ventilators.
"The lung cells have been reported to develop extremely intense poisoning and inflammation, shortness of breath sets in and this can lead to acute respiratory distress syndrome (ARDS). Patients with ARDS may require mechanical ventilator support to help circulate oxygen in the body."
It further said, the Phase II results of this study revealed that Desidustat treatment led to increased red blood cell production and improved oxygen delivery to tissues. None of the hospitalised patients required a mechanical ventilator in the Desidustat arm, while 25% of COVID-19 patients on the standard of care arm required mechanical ventilation.
Pankaj R Patel, Chairman, Zydus Group said, “We are excited to report for the first time, this encouraging data of... Desidustat, showing the potential to help prevent acute respiratory distress syndrome (ARDS) in COVID-19 patients. ARDS is associated with high mortality rate and Zydus remains committed to further develop this novel therapy for patients suffering from ARDS."
Clinical and regulatory development of Desidustat in COVID-19 was executed in Mexico by Avant Santé Research Center S.A. de C.V., a leading Contract Research Organization (CRO) headquartered in Monterrey, Mexico, the company said.