Sun Pharmaceutical Industries has started phase two clinical trial on AQCH, a phytopharmaceutical (plant-derived) drug for the treatment of COVID-19.
The company got approval from Drugs Controller General of India (DCGI) for conducting phase two clinical trial in April. The clinical trial will be conducted across 12 centres in India on 210 patients with a duration of 10 days.
The results of the clinical trial are expected by October. Human safety study of AQCH has already been completed and the drug has been found safe at the recommended dose for phase two study.
Managing Director Dilip Shanghvi said it 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 the International Centre for Genetic Engineering and Biotechnology (ICGEB) in 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,” he said in a statement on Friday.
AQCH, which is being developed for dengue, has shown a broad antiviral effect in vitro studies and hence is being tested as a potential treatment option for COVID-19. Since 2016, Sun Pharma has been working closely with DBT-ICGEB under the leadership of Dr Navin Khanna and CSIR-IIIM under the leadership of Dr Ram Vishwakarma to develop a phytopharmaceutical drug for dengue.
The work on the evaluation of plant-derived drugs for the treatment of dengue started in 2007 under the auspices of the Department of Biotechnology’s (DBT) Task Force on Medicinal and Aromatic Plants.
Renu Swarup, Secretary of Department of Biotechnology, Ministry of Science and Technology, said: “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.”
Shekhar C Mande, Director General of Council of Scientific and Industrial Research (CSIR), said: “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 is the world’s fourth-largest speciality generic pharmaceutical company and India’s top pharmaceutical company. Delivering products for customers and patients in over 100 countries, its global presence is supported by manufacturing facilities spread across six continents which are approved by multiple regulatory agencies.