Zydus Cadila, an innovation-driven, global pharmaceutical company, announced the second Phase III DREAM-D trials of Desidustat, an Investigational New Drug (IND) targeted at treating anemia in dialysis dependent CKD patients.
Chronic kidney disease is a serious medical condition which is an unmet healthcare need involving gradual loss of functioning of kidneys eventually leading to kidney failure. More than 200 million people worldwide are estimated to be living with chronic kidney disease. In a chronic kidney disease condition, the kidneys fail to produce EPO and this leads to anemia.
Desidustat is a novel, oral, HIF-PH inhibitor being developed for treating anemia in CKD patients. This Phase III DREAM-D study will be a multicenter (50-60 sites in India), randomized, active controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Epoetin for the treatment of anemia in patients with CKD who are on dialysis.
Speaking on the development, Mr. Pankaj R. Patel, Chairman, Zydus Group said, "Based on the positive proof-of-concept established in the Phase 2 clinical trials, we are committed to developing this novel drug, Desidustat that can benefit millions of CKD patients. We believe that Desidustat has the potential to provide an oral, safer alternative to the currently available therapy which is in an injectable form."
The primary end-point in Phase III DREAM-D study will be the efficacy of Desidustat tablet versus Epoetin alfa injection based on the change of hemoglobin (Hb) levels at 24 weeks. The secondary end-points will include number of hemoglobin (Hb) responders, time to achieve target range Hb level, percentage of time spent in target Hb range, serum hepcidin levels, serum potassium (K+) levels, vascular endothelial growth factor (VEGF) levels, lipid profile and lipoproteins.
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