Sun Pharma approved for COVID-19 trial

01-Jun-2020 - Last updated on 01-Jun-2020 at 13:35 GMT

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The company has been given the go-ahead to launch clinical research testing Nafamostat as a potential treatment for patients diagnosed with the virus.

India-based Sun Pharmaceutical Industries reports it has received approval from the Drugs Controller General of India (DCGI) to conduct a clinical trial involving treatment of COVID-19 patients with the drug Nafamostat Mesilate. The drug has been approved in Japan for treatment of acute symptoms of pancreatitis and treatment of disseminated intravascular coagulation (DIC).

Dilip Shanghvi, managing director for 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,” Shanghvi added.

Researchers with the University of Tokyo and Leibniz (Germany) Institute for Primate Research reportedly have demonstrated Nafamostat, dosed in very low concentrations, suppresses a protein (TMPRSS2) that the COVID-19 virus uses to enter human lung cell. Additionally, scientists with Institut Pasteur in South Korea reportedly compared the antiviral efficacy of Nafamostat and 24 other drugs against SARSCoV-2 in in-vitro studies in human lung epithelial derived cells, finding Nafamostat to be the most potent drug.

Currently, three separate clinical trials are underway to test the efficacy of Nafamostat when treating COVID-19 patients. These include a clinical trial being headed by the University of Tokyo Hospital, another by Gyeongsang National University Hospital in South Korea, and a collaborative trial jointly run by University Hospital (Padova, Italy) University of Zurich (Switzerland) and Yokohoma City University in Japan.

In the face of the pandemic and worldwide effort to rapidly discover and develop viable treatment options, Sun Pharma representatives have announced plans to kick off clinical trials as soon as possible. The company reports it has initiated manufacturing of the drug’s active pharmaceutical ingredient (API) and finished Nafamostat at its production facilities in India, also harnessing technology from its Pola Pharma Japan subsidiary.