Companies

Zydus gets approval from Mexican authority to test Desidustat for Covid

Our Bureau: Ahmedabad | Updated on July 06, 2020

Cadila Healthcare (Zydus Cadila) has received approval from the regulatory authority of Mexico, COFEPRIS, for its one of the lead research candidates Desidustat to be tested in the management of Covid-19.

Clinical and regulatory development of Desidustat in Covid-19 is being executed in Mexico by Avant Santé Research Center S.A. de C.V., a leading contract research organisation (CRO) headquartered in Monterrey, Mexico, said a company release. The novel mechanism of targeting ‘hypoxia’ through HIF-PH inhibitor will be studied for the first time in Covid-19 patients.

The company informed the exchanges that it will be conducting a 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.

“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,” it said. Desidustat, currently undergoing Phase III clinical development, is a novel oral HIF-PH inhibitor for treating anemia.

Pankaj Patel, Chairman, Zydus Cadila, said: “At Zydus, we have been stepping up our efforts to fight the Covid-19 pandemic through therapeutic drugs, diagnostics and vaccines. With Desidustat we will study a novel approach for the management of Covid-19.”

Covid patients have been reported to display signs of ‘hypoxia’ leading to organ failure and death despite the use of antivirals, anti-inflammatory drugs or ventilators.

Haemoglobin level hit

An attack of the novel coronavirus pneumonia brings down the level of haemoglobin that can carry oxygen and carbon dioxide. 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, currently undergoing Phase 3 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.

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 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, the company stated.

Shares of Cadila Healthcare, the listed entity of the group, were trading at ₹363.40 apiece on the BSE, 0.78 per cent lower against their previous close.

Published on July 06, 2020

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