India-based Sun Pharmaceutical Industries has launched a Phase II clinical trial of plant-derived (phytopharmaceutical) drug AQCH to treat patients with Covid-19.
The company secured the Drugs Controller General of India (DCGI) approval for the trial in April this year.
AQCH is being developed for the treatment of dengue. The drug demonstrated broad antiviral effect in-vitro and is being assessed as a potential Covid-19 treatment.
Sun Pharma has been working with DBT-ICGE and CSIR-IIIM since 2016 for the development of a phytopharmaceutical drug for dengue.
CSIR director general Dr Shekhar Mande 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.”
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The Phase II clinical trial will be performed in 210 Covid-19 patients at 12 centres across India. The treatment duration for patients will be ten days, with results expected by October this year.
AQCH has already completed human safety study, where it was observed to be safe at the recommended dose for Phase II trial.
Sun Pharma managing director Dilip Shanghvi 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.”
Last week, Sun Pharma secured approval from the DCGI to conduct a clinical trial of pancreatitis drug Nafamostat Mesilate to treat Covid-19 patients in the country.
The drug has approval in Japan to improve acute symptoms of pancreatitis and treat Disseminated Intravascular Coagulation (DIC).