New Delhi, Oct 14 || The Indian Council of Medical Research (ICMR) on Monday announced a partnership with domestic pharma giant Zydus Lifesciences to initiate Phase 2 clinical trials of the drug Desidustat in patients with sickle cell disease.
ICMR formalised a Memorandum of Agreement (MoA) with Zydus for a Phase IIa, double-blind, randomised, placebo-controlled study to evaluate the efficacy and safety of Desidustat oral tablet against sickle cell disease -- a genetic blood disorder characterised by the presence of abnormal haemoglobin (Hb).
This comes after drug regulator DCGI recently granted permission to conduct a Phase IIa trial to evaluate the efficacy and safety of Desidustat.
Desidustat is a hypoxia-inducible factor (HIF)-prolyl hydroxylase inhibitor (PHI) that stimulates the production of erythropoietin (EPO), a hormone that boosts red blood cell production when oxygen levels are low in the blood.
“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. Rajiv Bahl, Secretary, the Department of Health Research and Director General, ICMR.
“Our vision is to ensure that India continues to lead in the development of innovative and affordable healthcare solutions,” he added.
The proportion of patients with Hb response (defined as more than 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.