AzurRx BioPharma has activated seven study sites in India for the Phase II RESERVOIR clinical trial of its micronised niclosamide tablets, called FW-1022, to treat Covid-19-related gastrointestinal (GI) infections.
The new sites expand the trial’s eleven sites in the US and the five sites in Ukraine, taking the total number of sites to 23.
Niclosamide is a prescription small molecule drug approved in 1982 by the US Food and Drug Administration to treat intestinal tapeworm infections.
Apart from antihelminthic activity, the drug was observed to exhibit anti-inflammatory and anti-viral properties.
FW-1022 is a niclosamide-based small molecule drug being developed for its potential anti-viral activity against Covid-19 GI infections.
The therapeutic is intended to lower viral load in the GI tract, treat infection symptoms and prevent viral transmission through the faecal spread. It is expected to be delivered as an oral immediate-release tablet.
AzurRx BioPharma president and CEO James Sapirstein said: “Expanding our clinical trial into India provides access to the second most populous country in the world and one that, unfortunately, continues to experience a devastating Covid-19 outbreak.
“The virus’ impact on the GI tract is often overshadowed by its effect on the respiratory system, however, Covid-19-related GI infection remains an undertreated symptom with devastating aftereffects.
“A safe and effective treatment that removes the virus from the gut is needed for the millions who have contracted and continue to fall victim to the virus.”
RESERVOIR is a two-part, two-arm, placebo-controlled trial ongoing to validate FW-1022’s safety in treating GI infections caused by Covid-19.
The trial will also assess the therapeutic’s efficacy to clear the SARS-CoV-2 virus from the GI tract.
The trial’s main measure of efficacy is the rate of faecal SARS-CoV-2 clearance, evaluated using reverse transcription-polymerase chain reaction (RT-PCR), with niclosamide versus placebo for up to six weeks.
AzurRx expects these long-term observation data to suggest that niclosamide can potentially improve ‘long haul’ symptoms of Covid-19.
Top-line data from the Phase II trial, which began in April, are expected in the first quarter of next year.