In a significant stride towards strengthening India’s clinical research ecosystem, Zydus Lifesciences Limited has formalized a Memorandum of Agreement (MoA) with the Indian Council of Medical Research (ICMR). This partnership aims to initiate Phase 2 clinical trials of Desidustat in patients suffering from Sickle Cell Disease. The collaboration underscores a commitment to improving healthcare solutions and advancing clinical research within the country.

This Phase IIa, double-blind, randomized, placebo-controlled, parallel, multi-centre, proof-of-concept study is co-funded and co-monitored by INTENT, the Indian National Clinical Trial and Education Network, along with the Clinical Studies and Trial Unit of the Division of Development Research, ICMR. The primary objective of this clinical trial is to evaluate the efficacy and safety of the Desidustat oral tablet for the treatment of Sickle Cell Disease.

A major focus of the trial will be the proportion of patients exhibiting Hb response, defined as a ≥ 1 g/dL increase in hemoglobin from baseline. This will be measured at week 4 and week 8, serving as the primary endpoint of the study. Additionally, the trial will evaluate several key secondary endpoints, including the mean change in hemoglobin, the proportion of patients requiring blood transfusions, the proportion of patients experiencing vaso-occlusive crises, and the mean change in percentage of HbSS. The clinical trial is registered under CTRI Registration: CTRI/2024/06/068363.

Dr. Rajiv Bahl, Secretary of the Department of Health Research and Director General of ICMR, emphasized the transformative potential of this collaboration. He stated, “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 the currently available drug, hydroxyurea. Our vision is to ensure that India continues to lead in the development of innovative and affordable healthcare solutions.”

Echoing this sentiment, Mr. Pankaj Patel, Chairman of Zydus Lifesciences Limited, highlighted the importance of public-private partnerships in the healthcare sector. He remarked, “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.”

This initiative by Zydus Lifesciences and ICMR is a significant advancement in the quest for better treatment options for Sickle Cell Disease. As the clinical trial progresses, it has the potential to bring forward a new therapeutic option that could significantly impact the lives of millions affected by this condition. The success of this study could pave the way for more innovative treatments, solidifying India's position as a leader in healthcare research and drug development.

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