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  • Patent allowed by the USPTO that includes claims for niclosamide as a treatment for COVID-19 GI infections
  • COVID-19 GI infections are a significant unmet clinical need; AzurRx estimates potential U.S. market size of $450-600 million or greater in first year depending on how quickly the pandemic is controlled
  • Phase 2 clinical study of oral niclosamide in COVID-19 planned for 1H 2021

DELRAY BEACH, Fla., Jan. 12, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, and First Wave Bio, Inc., (“First Wave Bio”) a clinical-stage biotechnology company developing novel gut-targeted small molecules for inflammatory bowel disease and other serious conditions, today jointly announced the United States Patent and Trademark Office (USPTO) has provided a notice of allowance for issuance of a patent (U.S. patent application number 16/835,307) that covers use of niclosamide as a treatment for COVID-19-associated GI disease.  

The allowed claims relate to a method for treating a digestive symptom in a subject diagnosed as having a COVID-19 viral infection comprising orally administering an effective amount of niclosamide to decrease the COVID-19 viral RNA load relative to a baseline.

One epidemiological study1 showed that COVID-19 patients admitted to the hospital with related GI symptoms progressed to severe/critical disease at a much higher rate than patients without these symptoms (22.97% vs 8.14%) and nearly 30% of patients only presented GI symptoms. The GI tract is believed to serve as a viral reservoir for SARS-CoV-2, the virus which causes COVID-19, and contributes to prolonged infection and transmission.

AzurRx and First Wave recently entered into an exclusive worldwide licensing agreement with First Wav Bio, for the use of First Wave’s patented and proprietary oral and rectal formulations of niclosamide for the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and COVID-19 GI disease. AzurRx anticipates initiating a Phase 2 trial of oral niclosamide, also called FW-1022, in patients with COVID-19, in the first half of 2021.

“We are greatly encouraged by the allowance of the patent application,” said James Sapirstein, President and CEO of AzurRx BioPharma.  “We believe that the FW-1022 clinical program, which supports this patent filing, has been considerably strengthened in advance of the initiation of our Phase 2 COVID-19 GI clinical trial in 1H’21. Our proprietary niclosamide formulation 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.”

Mr. Sapirstein continued, “We believe that there is both a significant unmet clinical need in treating COVID-19 GI infections and a substantial untapped market opportunity. It has been reported that approximately~18% of all COVID-19 cases2 have GI infections and symptoms. Based on this data, we estimate that there may be approximately 3.4 million patients having COVID GI infections in the U.S. and up to 15 million globally. We estimate that this represents a potential market size of $450-$600 million for COVID-19 GI infections in the U.S. in the first year alone if the trends continue.”

“First Wave was founded to maximize the therapeutic potential of proprietary forms of niclosamide, and the biology underlying COVID-19 is highly aligned with the mechanism of our gut-targeted suite of niclosamide-derived therapies in development,” said Gary D. Glick, Ph.D., Co-Founder and Chief Executive Officer of First Wave Bio. “Our novel approach and compelling translational data have delivered a strong intellectual property estate, including this landmark issuance for our field.”

About COVID-19 Gastrointestinal Infections
Gastrointestinal infection symptoms (severe diarrhea, vomiting and abdominal pain) have been reported in approximately 18% of COVID-19 cases2. Of the 19 million individuals who are reported to have contracted COVID-19 in the United States, this would translate into 3.4 million patients having GI infection. Of the 81 million cases globally, it would translate into 15 million patients.

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.

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 three gut-restricted GI assets. 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, currently in two Phase 2 clinical trials.  AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, FW-420, for grade 1 Immune Checkpoint Inhibitor Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit www.azurrx.com.

About First Wave Bio
First Wave Bio was founded to improve the lives of people living with IBD. Recent discoveries in immune cell metabolism have opened up the possibility of selectively targeting disease-causing immune cells to treat inflammatory diseases without unwanted side effects such as broad immunosuppression. First Wave has developed a suite of MetaWave product candidates, gut-restricted small molecules that target the metabolism of disease-causing Th17 cells. The company’s first clinical MetaWave program, FW-424, has shown benefits for patients with mild-to-moderate ulcerative colitis in a Phase 1b/2a trial. First Wave is advancing FW-424 through additional clinical studies in patients with mild-to-moderate IBD. Given FW-424’s novel mechanisms of action and established safety profile, First Wave believes that it has the potential to replace current standard-of-care and improve the lives of patients at all stages of IBD. For more information, visit FirstWavebio.com.

Forward-Looking Statements
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. Forward-looking statements include those relating to the offering of the Company’s securities, including as to the consummation of the offering described above, the expected proceeds from the offering, the intended use of proceeds and the timing of the closing of the offering, which may be affected by, among others, delays in satisfying or failure to satisfy closing conditions for the registered direct offering and concurrent private placement and adverse changes in general economic and market conditions. 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, 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 such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of its clinical assets, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 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.

For more information:

AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
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Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: (617) 430-7578 
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1Jin X, et al. Gut 2020:0:1-9.doi:10.1136/gutjnl-2020-320926.
2 Gut Journal: Vol 69, Issue 6: 2020; 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.