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Zydus Cadila Desidustat shows efficacy, safety in treating Hypoxia in COVID-19 patients

Ruchika SharmaWritten by Ruchika Sharma Published On 2021-01-26T11:00:07+05:30  |  Updated On 26 Jan 2021 11:00 AM IST
Zydus Cadila Desidustat shows efficacy, safety in treating Hypoxia in COVID-19 patients
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Ahmedabad: Drug major, Zydus Cadila, has recently announced that the company 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 reported to display signs of 'Hypoxia' leading to organ failure and death despite the use of antivirals, anti-inflammatory drugs or ventilators. 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, 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.

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."

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. Further the level of CRP and IL-6 are reported to predict respiratory failure in hospitalized symptomatic COVID-19 patients.

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. 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, Multicenter, Open-label, Randomized, ComparatorControlled 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 leading Contract Research Organization (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 Anemia. 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.

Read also: Zydus Cadila secures DCGI nod to start Phase III Clinical Trial of ZyCoV-D to prevent COVID



zydus cadilazydus cadila newshypoxiadesidustatcoid-19coronavirus
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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