India’s largest drug maker Sun Pharmaceutical Industries is getting ready to start the trials on a few drugs that have emerged as potential treatment candidates for Covid-19. This includes an anti-coagulant and anti-inflammatory drug nafamostat and another plant-based dengue drug candidate that Sun Pharma was developing along with government research institutes.
Sun Pharma stock was up 3.5 per cent on BSE on Friday.
On Friday, Sun Pharma said that it received the nod from the country’s drug regulator to initiate a clinical trial with nafamostat mesilate in Covid-19 patients. These will be phase II clinical trials on about 40 patients. This drug is approved in Japan for improvement of acute symptoms of pancreatitis as well as for treatment of DIC (Disseminated Intravascular Coagulation).
Basically, it is an anti-coagulant drug that has potential anti-inflammatory and anti-viral activities against Covid-19.
A group of scientists from the University of Tokyo, Japan, and the Leibniz Institute for Primate Research, Germany, recently demonstrated that nafamostat, at very low concentrations, suppresses a protein 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 SARSCoV-2 in in-vitro studies.
The International Journal of Infectious Diseases said in a May 26 report that three cases of Covid-19 pneumonia improved after treatment with nafamostat and that preliminary findings show that this drug can be considered for use in elderly patients with Covid19 pneumonia.
At present there are three clinical trials underway to test nafamostat in Covid19 patients around the world. Sun Pharma intends to start the India trials soon, but did not give a timeline for completion of the same.
“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,” Dilip Shanghvi, managing director, Sun Pharma.
Nafamostat is currently not sold in India. Sun Pharma has initiated manufacturing of both, the active pharmaceutical ingredient (API) and the finished product of Nafamostat in India, using technology from its subsidiary, Pola Pharma Japan.
Meanwhile, Sun Pharma has also received the nod from the Drug Controller General of India (DCGI) for conducting clinical trials on a repurposed dengue drug that it was developing with government research institutes. In 2016 the company had started working on this botanical medicine with the Department of Biotechnology- International Centre for Genetic Engineering and Biotechnology ( DBT-ICGEB) and the Council of Scientific and Industrial Research- Indian Institute of Integrative Medicine (CSIR-IIIM).
In April the company submitted a proposal to the DCGI to conduct clinical trials to test the efficacy of the drug derived from plant sources on Covid19. Sources claimed that the company has received the regulator’s nod last month. The trials are yet to start.
The novel drug was being developed for dengue and will now be repurposed for testing on Covid19 patients.
Indian drug makers are lining up testing of potential drug candidates on Covid19 patients. Mumbai based Glenmark too has started trials on favipiravir, an influenza drug that has shown some promise.