Sun Pharma gets DCGI nod for clinical trial with Nafamostat in COVID-19 patients

Sun Pharmaceutical Industries has announced that it has received approval from the Drugs Controller General of India (DCGI) to initiate a clinical trial with Nafamostat Mesilate in COVID-19 patients. Nafamostat is approved in Japan for the improvement of acute symptoms of pancreatitis and treatment of Disseminated Intravascular Coagulation (DIC).

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) that the COVID-19 virus uses to enter human lung cells.

Another group from Institut Pasteur, South Korea, also published data comparing antiviral efficacy of 24 drugs and Nafamostat, against SARS-CoV-2 in in-vitro studies in human lung epithelial-derived cells. In this research, Nafamostat was found to be the most potent drug and was able to inhibit virus entry at very low concentrations, consistent with findings from Japan and German labs3

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 (RACONA study).

Dilip Shanghvi, Managing Director, Sun Pharma said, “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. We believe it holds promise in the treatment of COVID-19 patients.”

Considering the pandemic situation and urgent need for newer treatment options, Sun Pharma 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.