Indian pharma giant Sun Pharmaceutical Industries Ltd 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).
The approval came after a group of scientists from the University of Tokyo, Japan, and Leibniz Institute for Primate Research, Germany, recently demonstrated that Nafamostat, at very low concentrations, suppresses a protein that 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, including Nafamostat, against coronavirus 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," Sun Pharma said in a statement.
Globally, three clinical trials are undergoing 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).
"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 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," Dilip Shanghvi, Managing Director, Sun Pharma said.
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 already initiated manufacturing of both -- the active pharmaceutical ingredient and the finished product of Nafamostat in India using technology from its subsidiary Pola Pharma Japan, the company said.
Like most countries, India too is contributing to the race to look for a coronavirus vaccine. The government said that 30 groups in the country are working to find a corona vaccine. Meanwhile, the Centre for Cellular and Molecular Biology has successfully isolated the virus from several isolates that would enable it to use the culture for coronavirus vaccine development.
On Friday, the government said the Centre for Cellular and Molecular Biology (CCMB) had established stable cultures of coronavirus from samples of patients. The fact that CCMB has successfully isolated the virus to culture it in the lab means that it would be able to work towards vaccine development and testing. "These cultures may also be helpful in the process of drug screening. Potential drugs can be tested against the virus in a test-tube for their efficacy," said the Ministry of Science and Technology.
Meanwhile, Sun Pharma shares touched an intraday high of Rs 481.95 and closed 3.53% or 16.20 points higher at 475.45 on the BSE.