Zydus Lifesciences Limited has announced a partnership with the Indian Council of Medical Research (ICMR) to initiate Phase 2 clinical trials for Desidustat in patients with sickle cell disease.
This Phase IIa study is a double-blind, randomised, placebo-controlled, multi-centre trial, aimed at evaluating the efficacy and safety of Desidustat oral tablets. Co-funded and co-monitored by the Indian National Clinical Trial and Education Network (INTENT) and ICMR’s Division of Development Research, the study will focus on patients’ haemoglobin response, defined as a ≥ 1 g/dL increase from baseline, measured at weeks 4 and 8.
Secondary endpoints include mean changes in haemoglobin levels, the proportion of patients requiring blood transfusions, incidence of vaso-occlusive crises, and changes in HbSS percentage. This trial marks a significant step toward developing an effective treatment for sickle cell disease.
Commenting on this collaboration, the Secretary of the Department of Health Research and Director General at ICMR, Dr Rajiv Bahl, said, “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.”
The Chairman of Zydus Lifesciences, Mr Pankaj Patel, said, “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.”
Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.
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