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Drugmaker Sun Pharmaceutical has started the second phase of clinical trials on AQCH, a phytopharmaceutical or plant-derived drug for the treatment of Covid-19.
The company received regulatory approval from the Drugs Controller General of India (DCGI) for conducting Phase II clinical trial in April this year. Results from the trial are expected by October, the company said.
The clinical trial will be conducted in 12 centres across India on 210 patients, for a treatment duration of 10 days. Human safety study for the drug has been completed and it has been found safe at the recommended dose for Phase II study.
Sun Pharma Managing Director Dilip Shanghvi said in a statement: “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.”
Treatment for dengue
AQCH, which is being developed for dengue, has shown broad antiviral effect in in vitro studies and hence is being tested as a potential treatment option for Covid-19, the company said. Since 2016, Sun has been working with DBT-ICGEB, under Navin Khanna and CSIR-IIIM, under Ram Vishwakarma, to develop a phytopharmaceutical drug for dengue. The work on evaluation of plant-derived drugs for the treatment of dengue started in 2007 under Department of Biotechnology’s (DBT) Task Force on Medicinal and Aromatic Plants, the company said.
Renu Swarup, DBT Secretary said that their 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,” she added.
Another Covid-probable trial
Just last month, Sun had received DCGI approval to start a clinical trial on Nafamostat Mesilate in Covid-19 patients. Nafamostat is approved in Japan for improvement of acute symptoms of pancreatitis and treatment of Disseminated Intravascular Coagulation (DIC).
Globally, there are three clinical trials currently underway 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), Sun had said.
The company had also initiated manufacturing of both, the active pharmaceutical ingredient and the finished product of Nafamostat in India, using technology from its subsidiary, Pola Pharma Japan, Sun said in a statement.
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