AzurRx BioPharma has expanded the ongoing Phase II RESERVOIR clinical trial of FW-1022 for the treatment of Covid-19-related gastrointestinal (GI) infections in Ukraine.
The company has concluded site initiation visits and added five new trial centres in the country.
FW-1022 is an oral tablet that consists of micronised niclosamide and is designed to carry increased concentrations of the drug directly to the GI tract.
AzurRx said that the GI tract is a likely reservoir for Covid-19 recurrence and faecal spread of SARS-CoV-2 since the entry receptor for the virus, ACE-2, is increasingly expressed on GI cells.
Niclosamide is a US Food and Drug Administration (FDA)-cleared prescription small molecule drug with anti-helminthic activity, as well as anti-inflammatory and anti-viral properties.
In April, AzurRx started the Phase II RESERVOIR trial to evaluate FW-1022 in patients with Covid-19-linked GI infection.
The two-part, two-arm, placebo-controlled trial will analyse the safety of FW-1022 and its efficacy to clear the SARS-CoV-2 virus from the GI tract as primary goals.
The rate of faecal SARS-CoV-2 clearance, assessed by RT-PCR, in subjects receiving niclosamide versus placebo for up to six weeks is the trial’s primary efficacy goal.
AzurRx expects top-line results from the trial in the first quarter of next year.
Furthermore, these long-term observation data could signify the potential of niclosamide to improve symptoms of long-haul Covid-19.
AzurRx BioPharma chairman, CEO and president James Sapirstein said: “Niclosamide represents an important advance in the fight to help Covid-19 patients overcome the debilitating and often overlooked effect the virus can have on the GI system.
“The addition of new trial sites in Ukraine provides enhanced opportunity to enrol patients in a country where less than 5% of the population is fully vaccinated for Covid-19.”
Contract research organisation PPD is managing the RESERVOIR trial.
AzurRx is currently developing another micronised niclosamide formulation, FW-420, for the treatment of immune checkpoint inhibitor-associated colitis.