Ahmedabad: Pharma major Zydus Lifesciences on Thursday received approval to conduct a Phase III clinical trial of Desidustat in patients with sickle cell disease, the company said in a stock exchange filing.The 203-day trial, to be conducted in collaboration with the Indian Council of Medical Research (ICMR), will enrol 164 patients. It will assess the efficacy and safety of Desidustat oral tablets in treating anaemia among patients with sickle cell disease.The Phase III study will be a double-blind, randomised, placebo-controlled, parallel-group and multicentre trial. No serious adverse events were reported during the Phase II study, the company said.“Sickle cell disease severely affects the lives of millions of people and represents a significant unmet medical need. We are pleased to collaborate with ICMR to develop new and effective therapeutic options,” Zydus Lifesciences managing director Sharvil Patel said.ICMR director general Rajiv Bahl said the collaboration would help advance the drug into Phase III trials after the successful completion of the Phase II study. The US Food and Drug Administration has granted orphan drug designation to Desidustat for the treatment of sickle cell disease and beta-thalassaemia.
