New Delhi: Sun Pharmaceutical, the country’s largest drugmaker, has received permission from the country’s apex drug regulatory body to start clinical trials of a plant-based drug, AQCH, to see if it can treat Covid-19 patients.
It is the first phytopharmaceutical drug that the Drug Controller General of India (DCGI) has approved for clinical trial for Covid-19. Meant for the treatment of dengue, AQCH is still in the trial stage.
“The clinical trial will be conducted across 12 centres 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,” the company said in a press statement issued Friday.
“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.
ThePrint reported in April the Mumbai-based drugmaker has submitted a proposal to the DCGI to conduct limited randomised trials to test the efficacy of the drug in treating Covid-19.
The company has been developing the phytochemical-based drug to treat dengue for the last four years in collaboration with the Department of Biotechnology International Centre for Genetic Engineering and Biotechnology (DBT-ICGEB) and the Council of Scientific and Industrial Research (CSIR).
The clinical trials will be conducted by Sun Pharma in collaboration with the DBT-ICBEB and CSIR.
Dengue drug to be repurposed
AQCH has shown broad antiviral effect in in-vitro studies and is, hence, being tested as a potential treatment option for Covid-19, the company said.
Since 2016, Sun Pharma has been working very closely with the Department of Biotechnology (DBT), which functions under the Ministry of Science and Technology, to develop a phytopharmaceutical drug for dengue.
Dilip Shanghvi, Managing Director, Sun Pharma, said in the statement: “This is the first phytopharmaceutical drug approved for clinical trials by the DCGI as a potential treatment for Covid-19.”
Shanghvi added: “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.”
Dr Renu Swarup, Secretary, Department of Biotechnology, 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.”
‘Covid & dengue viruses behave similarly’
The plant-based drug is made by using cissampelos pareira (Cipa) plant variety, which is a natural source of potent antiviral activity against all four dengue virus serotypes.
The company had said coronavirus and dengue-causing viruses behave similarly in the human body.
According to a study published in the Public Library of Science in 2015: “Cipa in addition to inherent antipyretic activity in Wistar rats, it possessed the ability to down-regulate the production of TNF-α, a cytokine implicated in severe dengue disease. Importantly, it showed no evidence of toxicity in Wistar rats, when administered at doses as high as 2g/Kg body weight for up to 1 week.”
The research concluded that it “warrants further work to explore Cipa as a source for the development of an inexpensive herbal formulation for dengue therapy. This may be of practical relevance to a dengue-endemic resource-poor country such as India”.
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