Sun Pharma gets DCGI nod to conduct clinical trials of potential COVID-19 drug

Drug major Sun Pharma on Friday said it has received approval from the Drugs Controller General of India (DCGI) to initiate a clinical trial of Nafamostat Mesilate on COVID-19 patients Nafamostat is approved in Japan for improvement of acute symptoms of pancreatitis and treatment of disseminated intravascular coagulation (DIC). “Sun Pharma is constantly evaluating potential targets that can be explored for treating COVID-19 patients. Nafamostat has shown promising data  against SARS-CoV-2 virus in in-vitro studies conducted by three independent groups of scientists in Europe, Japan and South Korea," Sun Pharmaceutical Industries MD  Dilip Shanghvi said in a statement.

The Mumbai-based firm believes the drug holds promise in the treatment of COVID-19 patients, he added. Considering the pandemic situation and urgent need for newer treatment options, the company said it plans to initiate the clinical trials at the earliest.  The company has initiated manufacturing of both, the API and  the finished product of Nafamostat in India, using technology from its subsidiary, Pola Pharma Japan, it added.

A group of scientists from the University of Tokyo, Japan and Leibniz Institute for Primate Research, Germany, have recently demonstrated that Nafamostat, at very low concentrations, suppresses a protein (TMPRSS2) which the COVID-19 virus uses to enter human lung cells, the drug firm noted.  Globally, there are three clinical trials currently underway to test Nafamostat in COVID-19 patients.  These trials are being led by the University of Tokyo Hospital, Japan; Gyeongsang National University Hospital (South Korea); and a collaborative trial by University Hospital, Padova, Italy, University of Zurich, Switzerland and Yokohoma City University, Japan..