Silicon Valley-based biotech start-up ANA Therapeutics has commenced a phase 2/3 clinical trial of oral niclosamide (ANA001) to treat the Covid-19 disease.
The multicentre trial has been designed to assess the safety and efficacy of oral niclosamide formulation to treat patients with moderate Covid-19 disease.
The study is said to be the first in the US to test the potential of niclosamide, a drug used to treat tapeworm infections, for Covid-19.
Niclosamide, which is not yet available in the US, has demonstrated anti-inflammatory activity via NF-κB and STAT3 transcription factors to generate the expression of molecules that cause inflammation. It also exhibits antiviral properties.
ANA Therapeutics will conduct the randomised and placebo-controlled study in two parts at up to 20 clinical sites in the US.
The company will administer a seven-day course of niclosamide capsules for hospitalised patients with moderate Covid-19 in both study parts. It will also implement a standard of care for the patients in the trial.
According to the company, the first part of the trail’s primary objective is the evaluation of safety and tolerability, while the secondary objectives comprise measurement of efficacy and pharmacokinetics.
ANA Therapeutics will recruit several hundred patients in the second part of the trial. Its primary objectives include the assessment of niclosamide’s efficacy, safety and tolerability, while the secondary objectives comprise clinical improvement and the need and duration for rescue therapy.
ANA Therapeutics Co-founder and CEO Akash Bakshi said: “ANA Therapeutics refocused its business with the emergence of COVID-19 to utilize our expertise in niclosamide and drug formulation.
“We have moved quickly to bring niclosamide into clinical trials and expect to accelerate development further through partnerships to deliver this product as an important new therapeutic option for Covid-19 patients.”
Recently, ImmunityBio and NantKwest have dosed the first patient in phase I clinical study of a novel Covid-19 vaccine candidate called hAd5-Covid-19.