Zydus and ICMR Initiate Phase 2 Trial of Desidustat for Sickle Cell Disease

Zydus Lifesciences Ltd and ICMR have initiated a Phase 2 proof-of-concept trial of Desidustat in patients with Sickle Cell Disease. The trial is co-funded and co-monitored by INTENT, Indian National Clinical Trial and Education Network, Clinical Studies and Trial Unit, Division of Development Research, ICMR. The primary endpoint is to measure the proportion of patients with Hb response at week 4 and week 8. The trial will also evaluate key secondary endpoints including mean change in haemoglobin, proportion of patients requiring blood transfusions, proportion of patients experiencing vaso-occlusive crisis and mean change in percentage of HbSS. Desidustat is a hypoxia inducible factor (HIF)-prolyl hydroxylase inhibitor (PHI) and stimulates EPO production in a similar manner that happens in response to hypoxia. It has been approved for treatment of anemia in Chronic Kidney Disease patients not-on-dialysis and patients on-dialysis.