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June 7, 2021updated 12 Jul 2022 11:13am

India’s CSIR commences Phase II trials of Niclosamide for Covid-19 

Niclosamide’s safety profile was analysed over time and was shown to be safe for use in humans at varying dose levels.

The Council of Scientific & Industrial Research (CSIR) in India and Laxai Life Sciences have commenced a Phase II clinical trial of an anti-helminitic drug, Niclosamide, for Covid-19 treatment.

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The multi-centre, randomised, open-label Phase II study will assess the efficacy, safety, and tolerability of the repurposed drug in hospitalised patients.

Niclosamide is a generic drug used in treating tapeworm infection in adults and children. It is cost-effective and widely available in the country.

CSIR noted that the drug’s safety profile was analysed over time, demonstrating its safety for use in humans at varying dose levels.

While analysing drugs that can hinder syncytia formation, Niclosamide was detected as a promising repurposed drug by a research panel at King’s College London, who were partners in this project.

The syncytia or fused cells found in Covid-19 patients’ lungs are supposed to be the result of SARS-CoV-2 spike protein’s fusogenic activity and Niclosamide can block the formation of syncytia.

Furthermore, a research partnership between CSIR-Indian Institute of Integrative Medicine (CSIR-IIIM), Jammu, and the National Centre for Biological Sciences (NCBS), Bangalore showed that the drug can potentially hinder SARS-CoV2 by obstructing the viral entry via the pH-dependent endocytic pathway.

CSIR-Indian Institute of Chemical Technology, Hyderabad director Dr Srivari Chandrashekhar said that Laxai Life Sciences is developing the active pharmaceutical ingredient (API).

Laxai is using improved technology developed at IICT to make the API. The lab is a partner in the Phase II trial, which aims to offer a cost-effective Covid-19 therapeutic.

On obtaining favourable clinical data from clinical trials in India, an emergency use authorisation will be pursued in a bid to make more therapy options available for the disease.

Laxai Life Sciences CEO Dr Ram Upadhayaya said that efforts to conduct clinical trials were started last year after realising Niclosamide’s potential.

Upadhayaya added: “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.”

Last month, the CSIR proposed the testing of a sepsis treatment drug as a vaccine for Covid-19.

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