AzurRx BioPharma Announces Positive Results from Independent Data Monitoring Committee Review of Safety Data from Part 1 of RESERVOIR Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections
Review of Interim Safety Data Concluded with Favorable Recommendation to Continue RESERVOIR Trial as Planned
Part 2 of RESERVOIR Trial to Enroll Up to 150 Patients to Evaluate Efficacy of FW-1022 and Extend Safety Observations
BOCA RATON, Fla., Sept. 09, 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 an independent data monitoring committee (DMC) approved initiating patient enrollment in Part 2 of the 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 developed to remove SARS-CoV-2 (SARS2), the virus that causes COVID-19, from the GI tract.
The committee’s recommendation followed its review of safety data collected from 9 patients enrolled in Part 1 of the RESERVOIR trial. During Part 2, the trial will enroll up to 150 patients at clinical trial sites in the U.S., Ukraine and India and focus on demonstrating the efficacy of FW-1022 in clearing the COVID virus from the GI tract and expanding previous safety observations. Topline study data is expected during the first quarter of 2022.
James Sapirstein, President and CEO of AzurRx BioPharma, stated, “We greatly appreciate the thoughtful analysis and guidance provided by the DMC following its review of the data from Part 1 of the RESERVOIR trial. Consistent with our expectations, the early safety data supports the continued exploration of FW-1022 and the committee has recommended that we continue to Part 2 of the trial without modification. This marks an important step in our efforts to advance the development of FW-1022 and our broader goal to bring relief to the millions of COVID-19 patients – roughly 18% or one out of every six – fighting the debilitating and discomforting gastrointestinal symptoms caused by the virus.”
RESERVOIR is designed as a two-part, two-arm, randomized, placebo-controlled Phase 2 study with a primary purpose to confirm the safety of FW-1022 and assess the drug’s ability to remove the SARS-CoV-2 (SARS2) virus from the digestive tract. Patients enrolled in Part 2 of the study will be chosen randomly to receive either niclosamide or a placebo. After 14 days, patients will cease treatment but remain under observation for up to six weeks. The efficacy of FW-1022 will be measured by the rate of SARS2 clearance from stool samples assessed by PCR test, comparing the niclosamide arm and the control arm. Long-term observation could indicate whether niclosamide treatment has the potential to improve “long haul” COVID-19 symptoms.
James Pennington, M.D., Chief Medical Officer of AzurRx, commented, “COVID-19 remains a pernicious disease due to the rise of variant forms of the virus, and the so-called ‘long haul’ COVID-19 has developed into a major medical issue. Research suggests the virus often hides in the GI tract, forming reservoirs and causing illness long after the initial infection has abated, and unfortunately, there are no approved treatments for these patients. Early data demonstrated that FW-1022 is well tolerated, and we believe that our micronized oral niclosamide therapy has the ability to target the SARS2 virus directly in the gastrointestinal tract, providing a much-needed weapon to the treatment paradigm. We look forward to reporting topline results from the RESERVOIR trial next year.”
About COVID-19 Gastrointestinal 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 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. Importantly, the manufacturing process for niclosamide can be scaled up to supply large populations quickly.
About AzurRx BioPharma, Inc.
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