First Wave BioPharma has concluded participant enrolment for the second part of the Phase II RESERVOIR clinical trial of its oral tablet, FW-COV, for treating gastrointestinal (GI) infections associated with Covid-19.
A total of 150 subjects were enrolled in the second part of the trial.
An oral formulation of micronised niclosamide, FW-COV is being developed for eliminating the SARS-CoV-2 virus from the GI tract.
Niclosamide is a prescription small molecule drug listed by the World Health Organization (WHO) as an essential therapeutic.
The two-part, two-arm, placebo-controlled, randomised trial will confirm FW-COV’s safety and evaluate its ability to eliminate the virus from the digestive tract.
Subjects enrolled in the second part of the trial were given either FW-COV or a placebo for 14 days and will be followed up for six weeks on concluding the treatment.
In the trial subjects, no drug-associated serious adverse events following treatment with FW-COV were observed.
Top-line results from the trial are expected in the first half of this year.
First Wave BioPharma president and CEO James Sapirstein said: “Based on the positive safety data observed thus far, combined with earlier published in vitro Covid efficacy data for niclosamide, we believe that FW-COV has the potential to contribute to the global need for new therapies against SARS2.
“Furthermore, because niclosamide targets the entire virus and not just the spike protein, we believe that FW-COV may prove effective against multiple strains of Covid-19, including the Delta and Omicron variants.”
The company plans to seek Emergency Use Authorization (EUA) this year if the Phase II trial is successful.
Institut Pasteur Korea recently identified niclosamide as a potent SARS-CoV-2 inhibitor possessing a 40-fold increased potency as against remdesivir.
Last November, an independent data monitoring committee recommended First Wave BioPharma to continue subject enrolment in the second part of the Phase II RESERVOIR trial of FW-COV to treat Covid-19 related GI infections.