Phase 2 clinical trial of Niclosamide drug for treatment of COVID-19 patients begins to evaluate efficacy

New Delhi, June 06: The CSIR and Laxai Life Sciences Private Limited have initiated phase II clinical trials of anti-helminitic drug 'Niclosamide' for the treatment of COVID-19 patients, a statement said on Sunday.
The trial is a multi-centric, randomised, open label clinical study to evaluate the efficacy, safety and tolerability of Niclosamide for treating hospitalised COVID-19 patients.

Niclosamide has been extensively used in the past for treating tapeworm infection in adults as well as children. The safety profile of this drug has been tested over time and has been found safe for human consumption at different dose levels, the Council for Scientific and Industrial Research (CSIR) said.

Ram Vishwakarma, advisor to Director General CSIR, pointed out 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, which collaborated in this project.

The syncytia or fused cells observed in the lungs of patients with novel coronavirus infection probably result from the fusogenic activity of the SARS-CoV-2 spike protein and Niclosamide can inhibit this syncytia formation.

Independently, a collaborative research between CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu and the National Centre for Biological Sciences, Bengaluru had recently demonstrated that Niclosamide was 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 trial in COVID-19 patients.

Srivari Chandrashekhar, director, CSIR-Indian Institute of Chemical Technology (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 the ongoing trial is successful.

Ram Upadhayaya, CEO, Laxai Life Sciences noted that realising the potential of Niclosamide, efforts were initiated last year itself to undertake the clinical trials.

Having received approval from drug regulators, the clinical trial has been initiated this week at different sites and is expected to be completed within 8-12 weeks, the CSIR said.

Based on successful clinical evidence generated during the clinical trials in Indian studies, emergency use authorisation may be sought so that more treatment options are available to COVID-19 patients, it added.