Todos Medical and NLC Pharma have reported that Tollovir met its primary and key secondary endpoints in a Phase II clinical trial to treat hospitalised patients with severe and critical Covid-19.
Named Study NLC-V-01, the double-blind, placebo-controlled, randomised Phase II trial analysed the efficacy and safety of NLC-V (Tollovir) in adult subjects admitted to hospital due to Covid-19.
The trial intended to randomise nearly 78 subjects into a 1:1 ratio and stratified by weight to receive either Tollovir or placebo, apart from the standard of care.
Participants requiring mechanical ventilation were given the randomised therapy using liquid syrup.
In November last year, the companies concluded enrolment following the recruitment of 31 subjects to carry out an interim assessment to analyse Tollovir’s safety and efficacy.
The trial was carried out in two parts with Part 1 enrolling subjects from December 2020 to February last year when there were cases of Alpha and Beta variants of the SARS-CoV-2 virus.
Part 2 had subjects enrolled from May to November last year during the prevalence of the Delta variant.
According to the positive interim results, Tollovir met its primary goal of lowering time to clinical improvement as well as various crucial secondary clinical endpoints, including a complete decline in Covid-19 deaths.
Tollovir arm of Part 2 of the trial had an average decline of 2.7 days in time to clinical improvement, as assessed by the National Emergency Warning System 2 (NEWS2) versus placebo.
Furthermore, no cases of deaths linked to Covid-19 were reported in the Tollovir arm as against 22% in the placebo arm.
The Phase II trial was closed by the company early due to positive interim efficacy results.
Todos Medical president and CEO Gerald Commissiong said: “We are extremely pleased with the results from this clinical study in the hospital setting of our dual mechanism antiviral and anti-cytokine oral drug candidate Tollovir.
“We have already begun preparing manufacturing for commercial quantities of Tollovir so that we will be able to deliver shipments in jurisdictions where we expect to be granted accelerated Emergency Use Authorization (EUA) and are in the process of fine-tuning our proposed Phase II/III clinical study protocol for hospitalised Covid-19 patients.”
Tollovir is an oral antiviral inhibitor of 3CL protease. It is also an anti-cytokine therapy candidate to treat nidovirus subcategory of coronaviruses comprising SARS-CoV-2, Covid-19, SARS-CoV-1, MERS and 229E.