The company received approval from Drugs Controller General of India for conducting the trials of phytopharmaceutical drug in April
New Delhi: Drug major Sun Pharmaceutical Industries on Friday said it has commenced phase-2 clinical trials on AQCH, a plant-derived drug, for potential treatment of COVID-19.
The company received approval from the Drugs Controller General of India (DCGI) for conducting the trials of the phytopharmaceutical drug in April this year, Sun Pharma said in a statement.
"The clinical trials will be conducted across 12 centres in India on 210 patients. The treatment duration for patients will be 10 days. The results of the clinical trials are expected by October 2020," it added.
Human safety study of AQCH has already been completed and the drug has been found safe at the recommended dose for phase-2 study, 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," Sun Pharma MD Dilip Shanghvi said.
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, he added.
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, Sun Pharma 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," Department of Biotechnology Secretary Renu Swarup said.
Stating that Council of Scientific and Industrial Research (CSIR) has had a close association with the Indian pharma industry, CSIR DG Shekhar C Mande said the council 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".
Shares of Sun Pharmaceutical Industries were trading at Rs 504.15 per scrip on BSE, up 1.67 per cent from their previous close.