Express Pharma

Zydus announces publication of “Dream-ND” and “Dream-D” phase-III trials of Desidustat in “American Journal of Nephrology”

Desidustat’s development is based on the Nobel Prize in Medicine winning science on discoveries of the oxygen-sensing mechanism of cells through Hypoxia-Inducible Factor (HIF)

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Zydus Lifesciences today announced the publication of two manuscripts detailing the Dream-ND and Dream-D phase-III study results of Desidustat, a novel HIF-PH inhibitor, in the American Journal of Nephrology, the company notified in a statement.

Desidustat’s development is based on the Nobel Prize in Medicine winning science on discoveries of the oxygen-sensing mechanism of cells through Hypoxia-Inducible Factor (HIF). Desidustat works by stabilising the HIF complex and stimulating endogenous erythropoietin production in Chronic Kidney Disease (CKD) patients thereby improving
haemoglobin levels and treating anaemia. CKD patients, irrespective of their dialysis status, have been reported to develop anaemia, leading to significant morbidity, mortality, progression of kidney disease and higher blood transfusion rates.

In the Dream-ND trial, Desidustat oral dose was administered thrice a week compared to Darbepoetin subcutaneous injection in 588 CKD patients not-on-dialysis (randomised 1:1). In the Desidustat group, the mean baseline haemoglobin level was 8.97 g/dL which improved to 10.90 g/dL in weeks 16–24, and in the Darpepoetin group, the mean baseline haemoglobin levels was 8.92 g/dL which improved to 10.77 g/dL, which met pre-specified non-inferiority of Desidustat to Darbepoetin, as per protocol. The haemoglobin responders were significantly higher in the Desidustat group compared to the Darbepoetin group. There was a statistically significant reduction in hepcidin and LDL-c in the Desidustat arm as compared to the injectable Darbepoetin arm. The safety profile of the Desidustat oral tablet was comparable with the Darbepoetin alfa injection in CKD patients not on dialysis, the statement added.

It also said that in the DREAM-D trial, Desidustat oral tablets were administered thrice a week compared to Epoetin alfa subcutaneous injection in 392 CKD patients on dialysis (randomised 1:1). In the Desidustat group, the mean baseline haemoglobin level was 9.57 g/dL which improved to 10.47 g/dL in weeks 16–24, and in the Epoetin group, the mean baseline haemoglobin level was 9.46 g/dL which improved to 10.32 g/dL, which met pre-specified non-inferiority of Desidustat to Epoetin, as per protocol. The number of haemoglobin responders were significantly higher in the Desidustat group as compared to the Epoetin alfa group. There was a statistically significant reduction in hepcidin and LDL-c in the Desidustat arm as compared to the injectable Epoetin alfa arm. The safety profile of the Desidustat oral tablet was comparable with the Epoetin alfa injection in CKD patients on dialysis.

Desidustat is currently approved only in India as Oxemia for patients with CKD-induced anaemia. It is currently undergoing phase-III clinical development in China for anaemia in CKD patients. Desidustat is under phase-I (b) clinical evaluation under a IND with the US Food and Drug Administration (FDA) for Chemotherapy Induced Anaemia (CIA) in cancer patients, according to the statement.

Previously, results of multiple other studies on Desidustat have been published in international peer-reviewed scientific journals of repute such as European Journal of Pharmacology, Journal of Medicinal Chemistry, Drug Development Research, Drug Research (Stuttg), Xenobiotica, American Journal of Nephrology and Clinical Pharmacokinetics, the statement concluded.

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