Sun Pharmaceutical Industries Ltd on Friday will start Phase II clinical trial on AQCH, a phytopharmaceutical plant-derived drug, for the treatment of COVID-19 after success in the first phase. The company received approval from the Drugs Controller General of India (DCGI) for conducting Phase II clinical trial in April. In the human safety study of AQCH, it was found that the drug is "safe" for the Phase II study. Notably, the pharma giant has also received approval to initiate a COVID-19 clinical trial with another drug, Nafamostat Mesilate.
The clinical trial will be conducted across 12 centres in India in 210 patients for 10 days. The results of the clinical trial are expected by October. "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 the mechanism of action through in-vitro and small animal studies give us the confidence to evaluate this potential treatment option for COVID-19 patients," Dilip Shanghvi, Managing Director, Sun Pharma, said.
Sun Pharma is working with DBT-ICGEB and CSIR-IIIM to develop a phytopharmaceutical drug for dengue since 2016. As per the company, AQCH has shown a broad antiviral effect in in-vitro studies and hence is being tested as a potential treatment option for COVID-19.
"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," Dr Renu Swarup, Secretary of Department of Biotechnology, Ministry of Science and Technology, said.
Dr Shekhar C Mande, Director General, CSI, has said that "CSIR has had a long-standing association with the pharmaceutical industry in India and welcomes this collaboration with Sun Pharma in taking forward AQCH into clinical trials for COVID-19 patients. This collaboration aligns with our scientific rationale for the quickest way to develop drugs against SARS-CoV-2."
Sun Pharma has also received approval from the Drugs Controller General of India (DCGI) to initiate a clinical trial with Nafamostat Mesilate -- approved in Japan for the improvement of acute symptoms of pancreatitis and treatment of Disseminated Intravascular Coagulation (DIC) -- in COVID-19 patients. 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.
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).