Todos Medical has started a Phase II clinical trial to evaluate the safety and efficacy of its antiviral NLC-V-01 (Tollovir), a potent 3CL protease inhibitor to treat hospitalised Covid-19 patients.
The 77-patient, randomised, double blind, placebo-controlled trial is being conducted at Shaare Zedek Medical Center in Jerusalem, Israel.
Todos Medical is developing the therapeutic agent Tollovir through a joint venture with NLC Pharma.
The company has dosed the first ten patients in the trial.
NLC Pharma co-founder and chief scientific officer Dr Dorit Arad said: “The launch of this clinical trial is a critical step towards the clinical validation of our proprietary scientific work that was recently further supported with data from the Dan Peer laboratory at Tel Aviv University in Israel, concluding that our proprietary medical grade 3CL protease inhibitor, Tollovir, is an antiviral therapeutic candidate for SARS-CoV-2’s based on its 3CL protease reproduction mechanism.
“I am glad that my pioneering academic work over the last 30 years on 3CL mechanisms has made such a significant impact, and that it is finally being recognised by leading pharmaceutical companies as a key target in the war against Covid-19 that could yield an easy-to-administer oral antiviral therapeutic capable of stopping SARS-CoV-2 replication, independent of different mutations that are emerging at the site of spike protein.”
Dose selection for the Phase II trial is supported by data from a randomised, placebo controlled, open label Phase Ib trial in 27 hospitalised patients with Covid-19.
Time to discharge from the hospital and time to clinical improvement based upon the National Early Warning Score 2 in Israel form the primary endpoints of the trial.
Secondary endpoints that are being examined are rate of change of measured parameters, rate of change in vital signs including blood pressure, heart rate, respiratory rate, saturation, and body temperature.
Time from the first day of receiving NLC-V treatment to negative RT-PCR test result, Covid-19 related deaths, incidence of deterioration, and need for mechanical ventilation and incidence and duration of time on supplemental oxygen are also being examined.