Benzinga | Aug 12, 2021 07:08AM EDT

AzurRx BioPharma Completes Initial Cohort Enrollment into Part 1 of its RESERVOIR Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections

AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has completed enrollment of the initial cohort into Part 1 of its ongoing RESERVOIR Phase 2 clinical trial evaluating FW-1022 as a treatment for COVID-19-related gastrointestinal (GI) infections. FW-1022 is a proprietary oral tablet formulation of micronized niclosamide for the treatment of COVID-19-related GI infections.



Once all patients in this cohort complete their full two weeks of treatment, the trial's Data Monitoring Committee (DMC) will review the safety data. Successful DMC review will then trigger enrollment into Part 2 of the trial, focused on demonstrating efficacy and extending safety observations.

James Sapirstein, President and CEO of AzurRx, stated, "Completion of enrollment in the first part of our Phase 2 RESERVOIR clinical trial is an important step in our plan to develop niclosamide as a potential treatment for COVID-19 related GI infection. Despite the availability of vaccines, COVID-19 continues to infect people at an alarming rate due to the emergence of more contagious variants. Ultimately, it is our belief that therapeutic solutions will be needed to truly put an end to this pandemic. We believe that niclosamide could play an important role on this front and we look forward to reporting topline results from the RESERVOIR trial in the first quarter of 2022."

The RESERVOIR clinical trial is designed as a two-part, two-arm, placebo-controlled Phase 2 study. The trial's primary objectives are to confirm the safety of FW-1022 in the treatment of patients with COVID-19-related GI infections and to evaluate its efficacy in clearing SARS-CoV-2 (SARS2), the virus that causes COVID-19, from the GI tract. The primary efficacy measure of the RESERVOIR trial is the rate of fecal SARS2 clearance (stool sample) assessed by PCR, comparing the niclosamide arm to the placebo arm for up to six weeks. These long-term observation data could indicate that niclosamide treatment has the potential to improve "long haul" COVID-19 symptoms.

James Pennington, M.D., Chief Medical Officer of AzurRx, commented, "Physicians continue to report that the GI infections caused by COVID-19 remain an underappreciated aspect of the disease, even though these symptoms impact almost 20 percent of COVID-19 patients. We believe our micronized oral niclosamide therapy has the potential to target the SARS2 virus directly in the gastrointestinal tract, where research suggests the virus often hides, replicates and causes illness long after the initial infection."