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
Gastrointestinal infection symptoms (severe diarrhea, vomiting and abdominal pain) have been reported in approximately 18% of COVID-19 cases.1 Of the 40 million individuals who are reported to have contracted COVID-19 in the U.S.,2 this would translate into over 7 million patients having GI infection. Of the 220 million cases reported globally,3 it would translate into almost 40 million patients. Furthermore, approximately 10% of patients who were infected with COVID have persistent symptoms months after their initial diagnosis.3 Approximately 86% of these COVID “long haulers” are reported to have GI infection symptoms, with 60% continuing to have diarrhea months after their initial infection.4
There is some evidence to support the view that the GI tract is a possible reservoir for recurrence and fecal spread of the COVID-19 virus as ACE-2, the entry receptor for COVID-19, is highly expressed on GI cells. There currently is no targeted treatment for COVID GI infections.
Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications. In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties.
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.
FW-1022 is a niclosamide based small molecule which the Company’s clinical trials may establish has anti-viral activity that is effective for the treatment of SARS-CoV-2 (COVID-19) gastrointestinal infections. FW-1022 is anticipated to be supplied as an oral immediate release tablet. The formulation to be used has been milled (micronized) to allow superior dissolution in the gut fluids. This in turn may allow local niclosamide concentrations to reach anti-viral levels. Thus, FW-1022 has the potential to benefit COVID patients by decreasing viral load in the GI tract, treating infection symptoms and preventing transmission of the virus through fecal spread.
About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of two gut-restricted GI assets in three clinical indications. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. AzurRx is also advancing two clinical programs using proprietary formulations of niclosamide, a small molecule with anti-viral and anti-inflammatory properties: FW-1022, for COVID-19 gastrointestinal infections and FW-420, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com.
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
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1 Gut Journal: Vol 69, Issue 6: 2020; JAMA Network: Vol 3, Issue 6: 2020; Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; Cheung Gastroenterology: Vol. 159, Issue 1: 2020
2 New York Times. (9/5/21) https://www.nytimes.com/interactive/2021/world/coronavirus-maps.html
3 Rubin, R. “As their numbers grow, COVID-19 “Long Haulers” Stump Experts”. https://jamanetwork.com/journals/jama/fullarticle/2771111 September 23, 2020.
4 Davis, et al. “Characterizing Long Covid in an International Cohort: 7 Months of Symptoms and their Impact”. https://www.medrxiv.org/content/10.1101/2020.12.24.20248802v2.full.pdf
5 Jeon S, Ko M, Lee J, Choi I, Byun SY, Park S, Shum D, Kim S. 2020. Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs. Antimicrob Agents Chemother 64:e00819-20. https://doi.org/10.1128/AAC.00819-20.