Anti-helminitic drug Niclosamide, which has been extensively used for treatment of tapeworm’s infection in adults as well as children, is now being evaluated for treatment of hospitalised Covid-19 patients. The Council for Scientific and Industrial Research (CSIR) in collaboration with Laxai Life Sciences Pvt. Ltd., has initiated Phase-II clinical trials with this repurposed drug.
“Having received approval from the drug regulator, the clinical trial has been initiated this week at different sites and we hope that the trial will be completed within 8-12 weeks. Based on clinical evidence generated during clinical trials in Indian studies, emergency use authorisation may be sought so that more treatment options are available to Covid-19 patients,” said Dr Ram Upadhayaya, CEO, Laxai Life Sciences
The trial is a multi-centric, phase-II, randomized, open label clinical study to evaluate its safety and tolerability for the treatment of 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.
Dr Ram Vishwakarma, Advisor to DG-CSIR, explained that in a screen to identify drugs that can inhibit syncytia formation, Niclosamide was identified as a promising repurposed drug by a research group from King’s College, London, who collaborated in this project.
“The syncytia or fused cells observed in the lungs of patients with Covid-19 probably results from the fusogenic activity of the SARS-CoV-2 spike protein and Niclosamide can inhibit syncytia formation,” he said.
Also, said Dr Vishwakarma, independent collaborative research between CSIR-IIIM, Jammu and NCBS, Bangalore has recently demonstrated that Niclosamide is also a potential SARS-CoV2 entry inhibitor blocking the viral entry through pH dependent endocytic pathway.
“Given these two independent experimental studies, Niclosamide has now emerged as a promising drug candidate for clinical trials in Covid-19 patients.”
Dr Srivari Chandrashekhar, Director CSIR-IICT Hyderabad, highlighted that the Active Pharmaceutical Ingredient (API) is being made by Laxai Life Sciences based on improved technology developed at IICT and the lab is a partner in this important clinical trial which could provide cost effective therapeutic options for patients if trial is successful.