Thursday, 25 February 2021

Zydus announces Ph 2(b) results of Desidustat in COVID-19 patients in Mexico

25 January 2021 | News

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

Source credit: Shutterstock

Source credit: Shutterstock

Zydus announced that it has received positive results from Phase 2(b) studies of Desidustat in COVID-19 patients conducted at Mexico. Patients infected with COVID-19 have been reportedly  displayed signs of ‘Hypoxia’ leading to organ failure and death despite the use of antivirals, anti-inflammatory drugs or ventilators. 

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.” 

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% of COVID-19 patients on the standard of care arm required mechanical ventilation.

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 the Phase 2b, multi-centre, 0pen-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 SA de CV, a leading Contract Research Organisation (CRO) headquartered in Monterrey, Mexico. 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.

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