Sun Pharma begins phase II clinical trial on dengue drug for Covid-19

This is the first phytopharmaceutical drug (plant based) that the country's drug regulator has approved for clinical trials for Covid-19.

India's largest drugmaker Sun Pharmaceutical Industries said on Friday that it has commenced phase II clinical trials on AQCH, a plant-derived drug that was originally developed for dengue, to see if it can potentially treat Covid-19.
 

The trial will be conducted across 12 centres in India on 210 patients. This is also the first phytopharmaceutical drug (plant based) that the country's drug regulator has approved for clinical trials for Covid-19. The company said that the results of the trial are expected by October this year. “Human safety study of AQCH has already been completed and the drug has been found safe at the recommended dose for phase II study,” it said.
 

Sun Pharma stock was down marginally at the end of day's trade on the BSE
 

Dilip Shanghvi, Managing Director, Sun Pharma said, “This is the first phytopharmaceutical drug approved for clinical trials by the DCGI as a potential treatment for Covid-19. AQCH has shown anti-SARS-CoV-2 effects in in-vitro studies conducted in collaboration with ICGEB, Italy. These results combined with information on mechanism of action through in-vitro and small animal studies give us the confidence to evaluate this potential treatment option for Covid-19 patients.”

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 Covid-19.
 

Renu Swarup, Secretary of Department of Biotechnology, Ministry of Science and Technology, stated, “Our efforts to develop a safe, effective and affordable drug against dengue started about 13 years ago. The collaborating team quickly initiated studies for the development of a drug against COVID-19. I wish the collaborating team success in the conduct of the clinical trial against COVID-19 and for the development of phytopharmaceutical drugs against other infectious diseases.”
 

Only recently, Sun Pharma  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 Disseminated Intravascular Coagulation (DIC). Basically, it is an anti-coagulant drug that has potential anti-inflammatory and anti-viral activity against Covid-19.
 

A group of scientists from University of Tokyo, Japan, and  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.