Hindustan Times ST (Jaipur)

CSIR, Laxai Life Sciences begin Niclosamid­e trial

- Press Trust of India

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

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