Hyderabad: Hyderabad-based Laxai Life Sciences Pvt Ltd in collaboration with the Council of Scientific and Industrial Research (CSIR) has sought regulatory approval to undertake phase-III clinical trials on humans for its antiviral therapies for Covid-19.
The clinical trial, named ‘MUCOVIN’, will be carried out in partnership with Medanta Medicity. The trials, to be carried for 17 to 21 days including screening and treatment, include 300 patients in four different groups of 75 patients.
Through phase-III trials, investigators will evaluate how the new therapeutics work and aim at demonstrating that the developed therapies are safe and effective treatment options for Covid-19.
In April, IICT announced its collaboration with Laxai Life Sciences for the synthesis of drugs to be used in the fight against Covid-19 and also to manufacture Active Pharmaceutical Ingredients (APIs) and intermediates.
The clinical trials will ‘rationally combine and repurpose anti-virals and host-directed therapies (HDTs), aimed at controlling the disease spread. The study will also determine the safety and efficacy of three combination drugs — Favipiravir and Colchicine, Umifenovir and Colchicine, and Nafamostat and 5-ALA.
“This unique combinatorial strategy (antivirals and HDTs) with repurposed drugs having complementary, additive and synergistic role has been adopted to increase therapeutic options for the Covid-19 treatment and help recover patients faster,” said Dr Shekhar C Mande, DG, CSIR.
Laxai Life Sciences CEO Dr Ram S Upadhayaya said that the clinical trials target the viral proteins essential for SARS-Cov-2 replication as well as factors that play a crucial role in the viral life cycle and contribute to the cytokine storm.
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