AzurRx BioPharma has started its Phase II clinical trial to evaluate micronised oral niclosamide tablets, known as FW-1022, in patients with Covid-19 gastrointestinal (GI) infection.
Patient enrolment for the Phase II two-part, two-arm, placebo-controlled RESERVOIR clinical trial is expected to begin this month, with topline data anticipated in the first quarter of next year.
The study has two primary objectives which will confirm the safety of the prescription small molecule drug niclosamide to treat patients with Covid-19 GI infection. They will also demonstrate efficacy in clearing the SARS-CoV-2 virus from the GI tract.
The rate of fecal SARS-CoV-2 virus clearance assessed by RT-PCR, comparing the niclosamide arm to the placebo arm for up to six months, forms the primary efficacy measure of the RESERVOIR trial.
These long-term observation data could indicate that treatment with niclosamide can potentially improve ‘long haul’ symptoms related to Covid-19.
Global contract research organisation PPD will manage the trial.
AzurRx BioPharma chairman, CEO and president James Sapirstein said: “For many, the after-effects of Covid-19 can be as bad as the disease itself, and this includes a growing number who experience severe GI complications due to what many believe is the ability of SARS-CoV-2 to hide in reservoirs within the GI tract.
“We believe micronised oral niclosamide has the potential to target SARS-CoV-2 directly in the gut and, doing so, become an important addition to the armamentarium of therapeutics that will unfortunately be required by many who contract Covid-19.”
Part 1 of the trial will study nine to 18 patients hospitalised with Covid-19 and GI positive stool or rectal swabs for SARS2.
For any signs of safety issues, patients will be treated for 14 days and observed closely. The safety profile will be reviewed by a Data Monitoring Committee.
The trial will then move on to Part 2 which will be conducted in outpatients with Covid-19 and PCR positive stool or rectal swabs for SARS2. It will have approximately 100 patients.