Sun Pharmaceutical Industries has initiated Phase II clinical trial on AQCH, a phytopharmaceutical drug, as a potential treatment for COVID-19 patients. The company received approval from the Drugs Controller General of India (DCGI) for conducting the Phase II clinical trial in April this year.
AQCH has shown anti-SARS-CoV-2 effects in in-vitro studies conducted in collaboration with ICGEB, Italy, the company said, adding that this is the first phytopharmaceutical drug approved for clinical trials by the DCGI as a potential treatment for COVID-19.
"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," Sun Pharmaceutical Industries said in a regulatory filing on Friday.
The human safety study of AQCH has already been completed and the drug has been found safe at the recommended dose for Phase II study, it 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,” said Dilip Shanghvi, Managing Director, Sun Pharmaceutical Industries.
AQCH has shown anti-SARS-CoV-2 effects in in-vitro studies conducted in collaboration with ICGEB, Italy, the company said, adding that this is the first phytopharmaceutical drug approved for clinical trials by the DCGI as a potential treatment for COVID-19.
"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," Sun Pharmaceutical Industries said in a regulatory filing on Friday.
The human safety study of AQCH has already been completed and the drug has been found safe at the recommended dose for Phase II study, it 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,” said Dilip Shanghvi, Managing Director, Sun Pharmaceutical Industries.
First Published: Jun 5, 2020 12:01 PM IST
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