Zydus Cadila, an innovation-driven, global Pharma company, has rounded up patient enrollment in DREAM-D and DREAM-ND phase III trials of Desidudat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for treatment of anaemia in patients with chronic kidney disease (CKD).
Pankaj R. Patel, Chairman, Zydus Group remarked: “The Completion of patient enrolment into the DREAM-D and DREAM-ND Phase III trials is a major milestone in the development program of Desidudat, and we are thankful to all the patients and investigators who have persisted in this scientific research in the midst of this COVID-19 pandemic to develop novel therapies for patients with Chronic Kidney Disease.”
With respect to regulatory filing, the DREAM-ND Phase III trial has now enrolled 599 CKD patients not-on-dialysis. The Phase II study is a multicenter (68 sites), randomized, active-controlled clinical trial to assess the safety and efficacy of Desidustat versus Darbepoetin for the treatment of anaemia in patients with chronic kidney disease (CKD) who are not on dialysis.
Patel added, “Desidudat has the potential to bring a paradigm shift in the management of CKD patients with anaemia as it could provide an oral, safer alternative to currently available injectable erythropoietin-stimulating agents (ESAs) by additionally reducing hepcidin, reducing triglycerides, reducing inflammation, and better iron mobilization.”
The Phase III trial is being carried out in 392 CKD patients on Dialysis. The primary endpoint in Phase III DREAM-D multicenter study (44 sites) will be the efficacy of Desidustat tablet versus Epoetin alfa injection according to the change of hemoglobin (Hb) levels. The secondary endpoints will include number of hemoglobin (Hb) responders, percentage of time spent in target Hb range, time to achieve target range Hb level, number of hemoglobin (Hb) responders, serum potassium (K+) levels, serum hepcidin levels, vascular endothelial growth factor (VEGF) levels, lipoproteins and lipid profile.
Desidudat had earlier achieved its primary endpoints in the Phase II clinical studies and displayed good safety profile, improved iron mobilization, downregulation of hepcidin, and reduced triglycerides in CKD patients. The Phase I trials were previously completed in Australia. Zydus has recently published that Desidustat in Phase 2(b) POC study carried out in Mexico confirmed potentials to help prevent acute respiratory distress syndrome (ARDS) in Covid-19 patients and also decreased anti-inflammatory markers including IL-6 and CRP, Cadila added.
Desidustat is also undergoing clinical trials for cancer chemotherapy induced anemia (CIA).