Council of Scientific and Industrial Research (CSIR) along and Laxai Life Sciences on Sunday initiated Phase-II clinical trial for anti-helminitic drug Niclosamide for treatment of Covid-19.
Council of Scientific and Industrial Research (CSIR) along and Laxai Life Sciences have initiated Phase-II clinical trial to test effectiveness of Niclosamide in treating Covid-19. Originally, the anti-helmintic drug has been used for treating taperworm infections in adults and children.
The Phase II clinical trial is a multi-centric, randomised, open label study to ascertain the efficacy, safety and tolerability of Niclosamide for the treatment of hospitalized Covid-19 patients, the Ministry of Science and Technology said on Sunday.
In its previous use as an anti-helmintic drug, the safety profile of Niclosamide has been tested over time and has been found safe for human consumption at different dose levels, the ministry further added.
Dr Ram Upadhayaya, CEO, Laxai Life Sciences, said that realising the potential of Niclosamide, efforts were initiated last year itself to undertake clinical trials. "After 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."
Dr Ram Vishwakarma, Advisor to DG-CSIR, pointed out that in a test 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 on 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.
Independently, 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, Dr Vishwakarma added. These two independent experimental studies prepared the ground for Niclosamide to be tested as a promising drug candidate for clinical trial 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. The collaboration with the pharmaceutical lab could provide cost effective therapeutic options for patients if trial is successful, he added.