Indian Council of Medical ResearchZydus Lifesciences has formalised a Memorandum of Agreement (MoA) with the Indian Council of Medical Research (ICMR) to initiate Phase 2 clinical trials of Desidustat in patients with Sickle Cell Disease.
This Phase IIa, double-blind, randomised, placebo-controlled, parallel, multi-centre, proof-ofconcept study, co-funded and co-monitored by INTENT, Indian National Clinical Trial and Education Network, Clinical Studies and Trial Unit, Division of Development Research, ICMR, will evaluate the efficacy and safety of Desidustat oral tablet for treatment of sickle cell disease. The proportion of patients with Hb response (defined as ≥ 1 g/dL increase in Hb from baseline) compared to placebo will be measured at week 4 and week 8 as the primary end-point. The trial will also evaluate Key Secondary Endpoints including Mean change in haemoglobin, the proportion of patients requiring blood transfusions, the proportion of patients experiencing vaso-occlusive crisis and mean change in the percentage of HbSS [CTRI Registration: CTRI/2024/06/068363].
Dr Rajiv Bahl, Secretary, Department of Health Research and Director General, ICMR, emphasised the potential of the project, stating, “Desidustat was invented in India, and patients with Sickle Cell disease need therapies in addition to the currently available drug, hydroxyurea, our vision is to ensure that India continues to lead in the development of innovative and affordable healthcare solutions.”
Pankaj Patel, Chairman, Zydus Lifesciences, mentioned, “Public-private partnerships in the healthcare sector are essential to deliver novel drugs to achieve the goals of the National Sickle Cell Anaemia Elimination Mission. The initiation of this study reaffirms hope for the 20 million Sickle Cell affected patients in the country for a high potential novel treatment.”