New Delhi: The Indian Council of Medical Research (ICMR) has formalized the Memorandum of Agreement (MoA) with Zydus Lifesciences Limited to initiate Phase 2 clinical trials of Desidustat in patients with Sickle Cell Disease.
This Phase IIa, double blind, randomized, placebo controlled, parallel, multicenter, proof-of-concept study, co-funded and co-monitored by Indian National Clinical Trial and Education Network (INTENT), 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.
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, proportion of patients requiring blood transfusions, proportion of patients experiencing vaso-occlusive crisis and mean change in percentage of HbSS.
Dr Rajiv Bahl, Secretary, Department of Health Research & Director General, ICMR, emphasized the transformative potential of the project.
“This collaboration reflects our commitment to advancing clinical research in India through strategic public-private partnerships. Desidustat was invented in India, and patients with Sickle Cell disease need therapies in addition to currently available drug, hydroxyurea, Our vision is to ensure that India continues to lead in the development of innovative and affordable healthcare solutions,” he said.
Pankaj Patel, Chairman of Zydus Lifesciences Limited, mentioned that “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,” he said.
Sickle Cell Disease
Sickle Cell Disease is a significant public health concern in India, particularly among certain tribal populations where the prevalence is higher. According to the National Health Mission (NHM) estimates, there are approximately 20 Million sickle cell-affected patients in the country.
Every year, 50,000 children with sickle cell anemia are estimated to be born in India. The Government of India recognizes the significant impact of Sickle Cell Disease SCD on public health, particularly among tribal populations where the prevalence of the disease is higher. Therapeutic options for management of SCD are limited. Hydroxyurea reduces the frequency of painful crises in SCD, but is not universally effective and associated with side-effects like neutropenia and thrombocytopenia. Blood transfusions are expensive, not uniformly accessible, and are accompanied by risks including alloimmunization, hemolysis, and transfusion iron overload.
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