Sun Pharma starts Phase II clinical trial on AQCH

The Company received approval from the Drugs Controller General of India (DCGI) for conducting Phase II clinical trial in April this year.

The clinical trial will be conducted across 12 centers in India in 210 patients. The treatment duration for patients will be 10 days. The results of the clinical trial are expected by October 2020. Human safety study of AQCH has already been completed and the drug has been found safe at the recommended dose for Phase II study.

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."

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. Since 2016, Sun Pharma has been working very 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 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 Plant.