Zydus’ Desidustat efficacious in treating hypoxia in Mexico’s hospitalised COVID-19 patients: Study

Zydus Cadila announced that it has received positive results from Phase 2(b) studies of Desidustat in COVID-19 patients [ClinicalTrials. govIdentifier: NCT04463602] conducted at Mexico.

“The Phase 2(b) 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 mechanical ventilator in the Desidustat arm, while 25 per cent of COVID-19 patients on the standard of care arm required mechanical ventilation. Further, the level of CRP and IL-6 are reported to predict respiratory failure in hospitalised symptomatic COVID-19 patients,” informed a statement from the company.

It has been reported that the risk of respiratory failure for patients with IL-6 levels of > 80 pg/ml was 22 times higher compared to patients with lower IL-6 levels (Refer: Tobias e¢ al, Elevated levels of IL-6 and CRP predict the need for mechanical ventilation in COVID-19, Journal of Allergy and Clinical Immunology, VOLUME 146, ISSUE 1). In this Phase 2(b) clinical study, the standard of care reported the mean increase in IL-6, while the Desidustat arm remained stabilised. Detailed reports will be published in a scientific journal.

Zydus had conducted Phase 2b, multicenter, open-label, randomised, comparator-controlled study to evaluate the efficacy and safety of Desidustat tablet for the management of COVID-19 patients. Clinical and regulatory development of Desidustat in COVID-19 was executed in Mexico by Avant Santé Research Center S.A. de C.V., a contract research organisation (CRO) headquartered in Monterrey, Mexico.

Speaking on the development, Pankaj R Patel, Chairman, Zydus Group said, “We are excited to report for the first time, this encouraging data of our novel HIF-PH inhibitor, 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.”

Zydus had initiated two Phase III trials of Desidustat. The DREAM-ND Phase III trial is being conducted in 588 CKD patients not-on-dialysis. The DREAM-D Phase III trial is being conducted in 392 CKD patients on Dialysis. Desidustat is also being studied in cancer chemotherapy-induced anaemia. Desidustat had previously met its primary endpoints in the Phase II clinical studies and showed good safety profile. The Phase I trials were earlier completed in Australia.