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COVID-19 cure: Sun Pharma dengue drug AQCH enters Phase II clinical trial

COVID-19 drug: The clinical trial will be conducted across 12 centres in India in 210 patients for 10 days and the results of the clinical trial are expected by October

twitter-logoBusinessToday.In | June 5, 2020 | Updated 13:02 IST
COVID-19 cure: Sun Pharma's dengue drug AQCH enters Phase II clinical trial
Sun Pharma has also received approval to initiate a COVID-19 clinical trial with another drug, Nafamostat Mesilate

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.

Also read: Sun Pharma gets DCGI nod to start clinical trial of Nafamostat drug in COVID-19 patients

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.

Also read: Coronavirus vaccine update: India to begin human trial in next six months, says ICMR

"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."

Also read: Coronavirus Vaccine: Latest updates from India and around the world

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).

Also read: Coronavirus vaccine: 30 groups in India working on candidate vaccines

Also read: Coronavirus vaccine: Indian researchers make breakthrough; 6 candidates in the works, says govt

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