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
BOCA RATON, Fla., Aug. 12, 2021 (GLOBE NEWSWIRE) -- 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.”
About Phase 2 RESERVOIR Clinical Trial
The two primary objectives of this trial are to confirm the safety of niclosamide in treatment of patients with COVID-19 GI infection, and to demonstrate efficacy in clearing the SARS-CoV-2 (SARS2) virus from the GI tract. Part 1 of the trial will study 9 to 18 patients with COVID-19 and GI positive stools for SARS2. Patients will be treated for 14 days and observed closely for any signs of safety issues. A Data Monitoring Committee will then review the safety profile and if niclosamide is well-tolerated, the trial will move on to Part 2.
Part 2 will be conducted in outpatients with COVID-19 and PCR positive stools for SARS2. Patients will be randomized to either niclosamide 400 mg tablets, three times a day, or to placebo tablets, three times a day. After 14 days of treatment, patients will be taken off study drugs and remain on study observation for up to 6 weeks. The efficacy endpoint is analyzed by time to clearance fromstools of SARS2, comparing the niclosamide arm to the placebo arm. Long term observation will also be important to indicate whether niclosamide treatment might improve ‘long haul’ COVID-19 symptoms.
About COVID-19 Gastrointestinal Infections
There is some evidence to support the view that the GI tract is a possible reservoir for recurrence and fecal spread of the SARS-CoV-2 virus as ACE-2, the entry receptor for COVID-19, is highly expressed on GI cells. There currently is no targeted treatment for COVID-19 GI infections.
There remains an urgent need to develop new medicines that can be manufactured at large scale quickly to treat COVID-19. Niclosamide was recently identified by the Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19, with potency 40X greater than remdesivir.5 Additionally, emerging evidence confirms the severe GI-related complications of COVID-19 and potential fecal spread of the virus. The Company’s clinical trials may establish that patients treated with an oral and non-systemic niclosamide formulation that delivers high local GI concentrations have decreased viral load and GI-associated symptoms of COVID-19. Importantly, the manufacturing process for niclosamide can be scaled up to supply large populations quickly.
About AzurRx BioPharma, Inc.
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