The Sun Pharmaceutical Industries Ltd announced approval from Indian drug authority known as the Drugs Controller General of India (DCGI) to launch a clinical trial with Nafamostat Mesylate in COVID-19 patients. A drug approved in Japan for improvement of acute symptoms of pancreatitis and treatment of Disseminated Intravascular Coagulation (DIC), a group of preclinical research investigators from the University of Tokyo, Japan and Leibniz Institute for Primate Research in Germany demonstrated that the drug, at low concentrations, suppresses the protein called TMPRSS2 that SARS-CoV-2 uses to enter human lung cells.
Moreover, another research group associated with Institut Pasteur, South Korea published data comparing antiviral efficacy of 24 drugs, and Nafamostat was found to be the most potent of the batch and capable of inhibiting the virus at very low concentrations, consistent with the findings from the Japanese and German preclinical research efforts.
Current Clinical Trials
According to the Sun Pharmaceutical press release, there are presently three clinical trials underway to test Nafamostat in COVID-19 patients. These trials are led by the University of Tokyo Hospital, Japan, Gyeongsang National University Hospital (South Korean), and a collaborative trial by University Hospital, Padova, University of Zurich, Switzerland, and Yokohama City University, Japan (RACONA) study which is disclosed in Clinicaltrials.gov.
The Sun Pharmaceutical Effort
One of India’s largest drug companies, Sun Pharma, has been monitoring for new COVID-19 research opportunities, reported Dilip Shanghvi, Managing Director of the company. The company believes it holds promise for the potential treatment against COVID-19. Sun Pharma has initiated the manufacturing of both the API and the finished product of Nafamostat in India using technology from its subsidiary, Pola Pharma, Japan.
Nafamostat mesylate is a synthetic serine protease inhibitor and short-acting anticoagulant. The drug has exhibited antiviral and anticancer properties. It is available in a generic form already used for the treatment of certain bleeding complications in some countries, but it carries risks of complications (including anaphylaxis) weighed against non-emergency care. The drug has been identified for potential use against COVID-19.
About Sun Pharmaceutical
Sun Pharmaceuticals Limited (NSE: SUNPHARMA) is an Indian multinational pharmaceutical company headquartered in Mumbai. They manufacture and sell pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India, but also in America and elsewhere. The company offers formulations in various therapeutic areas and supplies the goods for a number of well-known drugs.
By 2018, Sun Pharma was the fourth-largest generic company in the world with over $4 billion in revenues. Now with $4.5 billion and 32,000 employees, the company has a pipeline of over 120 ANDAs and several new drug applications (NDAs) as well, which include complex generics combinations, first-to-file opportunities, and pure generics.