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October 16, 2024 – New Delhi: In a significant stride towards addressing sickle cell disease, the Indian Council of Medical Research (ICMR) has entered into a partnership with Zydus Lifesciences to initiate Phase II clinical trials of the drug Desidustat. The collaboration marks a crucial step in providing innovative treatments for this debilitating genetic blood disorder that affects millions across India.
The formal Memorandum of Agreement (MoA) between ICMR and Zydus aims to evaluate the efficacy and safety of Desidustat, a hypoxia-inducible factor (HIF)-prolyl hydroxylase inhibitor (PHI), in patients with sickle cell disease. Desidustat, an oral tablet, works by stimulating the production of erythropoietin (EPO), a hormone that increases red blood cell production under low oxygen conditions—a critical factor for patients with abnormal hemoglobin (Hb), the hallmark of sickle cell disease.
The Phase IIa clinical trial will be a double-blind, randomized, placebo-controlled study, following recent approval from the Drug Controller General of India (DCGI). The primary focus of the trial is to measure the proportion of patients who exhibit a hemoglobin response, defined as an increase of more than 1 g/dL from baseline at weeks 4 and 8. Additionally, the trial will assess secondary outcomes such as changes in hemoglobin levels, the need for blood transfusions, and the occurrence of vaso-occlusive crises, which are painful episodes caused by sickled red blood cells blocking blood flow.
Dr. Rajiv Bahl, Secretary of the Department of Health Research and Director General of ICMR, emphasized the importance of this partnership in advancing healthcare innovation. “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,” said Dr. Bahl.
Pankaj Patel, Chairman of Zydus, echoed the sentiment, noting the urgent need for novel treatments in the fight against sickle cell disease. “The initiation of this study reaffirms hope for the 20 million sickle cell-affected patients in the country for a high-potential novel treatment. Public-private partnerships in healthcare are essential to achieving the goals of the National Sickle Cell Anaemia Elimination Mission,” Patel stated.
Sickle cell disease remains a major public health concern in India, particularly among certain tribal populations where its prevalence is significantly higher. Estimates from the National Health Mission (NHM) indicate that around 50,000 children are born with sickle cell anemia each year in the country. With the disease disproportionately affecting marginalized communities, this clinical trial is a vital step in offering new hope for millions.
Desidustat, which was originally developed at Zydus’ research and development labs, has already been approved for treating anemia in patients with chronic kidney disease. Its potential application in sickle cell disease could be a game-changer for individuals suffering from this life-threatening disorder.
As the trial progresses, it brings renewed optimism for patients and healthcare providers in India, who have long awaited effective alternatives to existing therapies. With the collaboration between ICMR and Zydus, India continues to demonstrate leadership in the development of affordable and innovative healthcare solutions for pressing public health challenges.
