CSIR-Laxai life sciences start phase II clinical trials on Niclosamide

The safety profile of this drug has been tested over time and has been found safe for human consumption at different dose levels. (Bloomberg)Premium
The safety profile of this drug has been tested over time and has been found safe for human consumption at different dose levels. (Bloomberg)
2 min read . Updated: 06 Jun 2021, 05:33 PM IST Neetu Chandra Sharma

The Council of Scientific and Industrial Research (CSIR) in collaboration with Laxai Life Sciences Pvt. Ltd, has initiated a Phase-II clinical trial of an anti-helminitic drug Niclosamide for treatment of covid-19. The trial is a multi-centric, phase-II, randomized, open-label clinical study to evaluate the efficacy, safety and tolerability of Niclosamide for the treatment of hospitalized Covid-19 patients.

Niclosamide has been extensively used in past for the treatment of 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 government said.

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“The subject expert committee (SEC) has given its recommendations to conduct this Phase II clinical trial using Niclosamide, which is a generic, affordable drug and easily available in India and therefore can be made available to our population," Dr Shekhar C Mande, Director General, CSIR said.

The syncytia or fused cells observed in the lungs of patients with covid-19 probably result from the fusogenic activity of the SARS-CoV-2 spike protein and Niclosamide can inhibit syncytia formation. Niclosamide was identified as a promising repurposed drug that can inhibit syncytia formation by the research group from King’s College, London, who collaborated in this project.

Independently, collaborative research between CSIR-IIIM, Jammu and NCBS, Bengaluru 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 a clinical trial in covid-19 patients.

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 trial is successful," Dr Srivari Chandrashekhar, Director CSIR-IICT Hyderabad said.

Realizing the potential of Niclosamide, efforts were initiated last year itself to undertake clinical trials. “Having received approval from drug regulator, the clinical trial has been initiated this week at different sites and is expected that the trial will be completed within 8-12 weeks. Based on successful clinical evidence generated during clinical trials in Indian studies, emergency use authorization may be sought so that more treatment options are available to covid-19 patients," Dr Ram Upadhayaya, CEO, Laxai said.

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