Sun Pharma gets DGCI nod to start clinical trials with Nafamostat mesylate

Sun Pharmaceutical Industries said on Friday it has received approval from the Drugs Controller General of India (DCGI) to initiate clinical trial with Nafamostat mesylate in COVID-19 patients.

Nafamostat is approved in Japan for improvement of acute symptoms of pancreatitis and treatment of disseminated intravascular coagulation (DIC).

A group of scientists from the University of Tokyo in Japan and Leibniz Institute for Primate Research in Germany 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 in 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 labs.

Globally, there are three clinical trials currently underway to test Nafamostat in Covid-19 patients. Thesetrials are being led by the University of Tokyo Hospital in Japan, Gyeongsang National University Hospital in South Korea, and a collaborative trial by University Hospital at Padova in Italy, University of Zurich in Switzerland and Yokohoma City University in Japan.

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 active pharma ingredient and the finished product of Nafamostat in India, using technology from its subsidiary, Pola Pharma Japan.

"Sun Pharma is constantly evaluating potential targets that can be explored for treating COVID-19 patients," said Managing Director Dilip Shanghvi.

"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," he said in a statement.