Clinical-stage biopharmaceutical company Clene Nanomedicine is set to initiate a Phase II clinical study of CNM-ZnAg liquid solution in acutely symptomatic, non-hospitalised Covid-19 patients.
A proprietary zinc-silver ionic solution, CNM-ZnAg has shown antiviral and antibacterial properties, as well as boosting immune response.
The latest development comes after the company received official approval from the Brazilian health regulatory agency, ANVISA, to conduct the trial.
The multi-centre, randomised, double-blind, placebo-controlled study will analyse the efficacy and safety of CNM-ZnAg in around 276 Covid-19 patients.
Participants in the trial will be randomised into a 1:1:2 ratio to receive either a low or high dose of ZnAg or placebo, along with standard supportive care.
The rate of decreased hospitalisations at day 28 will form the trial’s primary endpoint, while secondary endpoints will analyse time to symptom resolution.
Clene president and CEO Rob Etherington said: “In spite of vaccines recently becoming available, there remains a need for the development of therapeutics to treat symptomatic Covid-19 patients.
“While our primary focus remains on delivering potentially transformative solutions for patients with neurodegenerative diseases, we brought forward our CNM-ZnAg development candidate to the clinic rapidly as we believe our technology could make a positive impact for symptomatic Covid-19 patients.”
To be part of the Phase II study, subjects must have two or more symptoms of acute Covid-19 infection, which is self-reported as moderate or severe, within 96 hours before the baseline visit.
In addition, the infection must be confirmed by polymerase chain reaction (PCR) testing.
Clene noted that enrolment in the trial is anticipated to be completed by mid-year, with results expected in the second half this year.
The company has invented a new nanotechnology drug platform for developing a novel class of orally administered neurotherapeutic drugs.