Hyderabad-based Council Of Scientific And Industrial Research–Indian Institute Of Chemical Technology (CSIR-IICT) in collaboration with a pharma company has begun Phase 2 clinical trial of the anthelmintic drug Niclosamide for treatment of COVID-19 patients under hospitalisation. The drug could prove to be a cost-effective therapeutic option for COVID-19 patients, the researchers hope. Niclosamide, used over the years for the treatment of tapeworm infection in adults and children, is now being repurposed for COVID-19 treatment, based on findings from research carried out at King’s College in London. In India, independent collaborative research carried out by various research organisations has demonstrated that Niclosamide has the potential to inhibit SARS-CoV2, blocking the entry of the virus through the pH-dependent endocytic pathway.
The research in India was carried out by the Council of Scientific and Industrial Research (CSIR), CSIR-Indian Institute of Integrative Medicine (IIIM) in Jammu and the National Centre for Biological Sciences (NCBS) in Bengaluru. The trial is a multi-centric, Phase 2, randomised, open-label clinical study to evaluate the efficacy, safety and tolerability of Niclosamide for the treatment of hospitalised COVID-19 patients. The safety profile of this drug has been tested over time and has been found safe for human consumption at different dose levels. The Subject Expert Committee (SEC) has recommended carrying out the Phase 2 clinical trials using Niclosamide, said Dr Shekhar C Mande, Director General, CSIR.
Dr Srivari Chandrashekhar, Director of CSIR-IICT Hyderabad, highlighted that the Active Pharmaceutical Ingredient (API) for the repurposed drug is based on improved technology developed at IICT. The IICT has partnered with a Hyderabad-based pharmaceutical company Laxai Life Sciences for the clinical trial, which could provide cost-effective therapeutic options for patients, if the trial is successful.
The CEO of Laxai Life Sciences, Dr Ram Upadhayaya, said that the clinical trial had been initiated this week and was expected to be completed within eight to 12 weeks. The firm plans to seek emergency authorisation for the drug from the Drugs Controller General of India (DCGI) for the treatment of COVID-19 patients based on the success of Phase 2 clinical trial.