AZRX AzurRx BioPharma Inc

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, announced today the administration of the first dose of FW-1022 to a volunteer in the ongoing Phase 2 RESERVOIR clinical trial. FW-1022 is a proprietary oral tablet formulation of micronized niclosamide developed for the treatment of COVID-19-related GI infections. Topline results from the trial are expected in the first quarter of 2022.

“Dosing the first patient in the RESERVOIR clinical trial marks a significant milestone for AzurRx and the development of niclosamide as a potential treatment for COVID-19-related GI infections,” said James Sapirstein, Chief Executive Officer of AzurRx BioPharma. “There are currently no approved treatments available for COVID-19-related GI infections. If our development program is successful, we believe that FW-1022 could help prevent reinfection and the spread of COVID-19, as well as treat certain potentially severe complications that many people believe to be caused by the ability of SARS-CoV-2 to hide in reservoirs within the GI tract. We believe our micronized oral niclosamide therapy has the potential to target the virus directly in the gut and play an important role in treating COVID-19 patients experiencing the damaging aftereffects of COVID-19-related GI infection.”

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 from the GI tract. The primary efficacy measure of the RESERVOIR trial is the rate of fecal SARS-CoV-2 clearance (rectal swab or stool sample) assessed by RT-PCR, comparing the niclosamide arm to the placebo arm for up to six months. These long-term observation data could indicate that niclosamide treatment has the potential to improve “long haul” COVID-19 symptoms.

“As a practicing clinician, I have treated hundreds of COVID-19 patients with many reporting GI issues resulting from the virus, including severe diarrhea, vomiting and abdominal pain. However, COVID-related GI infection remains an underappreciated and often untreated aspect of the disease despite its prevalence and adverse impact on the patient,” said Salma Saiger, M.D., of SMS Clinical Research, LLC and an investigator with the RESERVOIR clinical trial. “Given this, there is a pressing need to develop therapeutics to directly treat SARS-CoV-2 that may be hiding in the GI tract. Preclinical evidence suggests that micronized niclosamide could provide such an opportunity, and I am excited to be part of the investigative team researching the drug in the Phase 2 RESERVOIR trial.”

“Evidence continues to build in support of niclosamide as a potential COVID-19 therapy, including research from the Institut Pasteur Korea suggesting that niclosamide could be 40 times more potent than remdesivir in inhibiting SARS-CoV-2,” said James Pennington, M.D., Chief Medical Officer of AzurRx. “We believe FW-1022, our micronized formulation of niclosamide, is ideally equipped to clear SARS-CoV-2 hiding in the gut due to its proven safety profile and known effectiveness in treating other GI ailments, and its ability to remain in the gut for long periods of time. We look forward to reporting topline data from RESERVOIR in early 2022.”

More information about this clinical trial is available at ClinicalTrials.gov.

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 33 million individuals who are reported to have contracted COVID-19 in the U.S.,2 this would translate into 6 million patients having GI infection. Of the 165 million cases globally,3 it would translate into almost 30 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.

About Niclosamide

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

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 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-1022 for COVID-19 gastrointestinal infections, and FW-420 for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com.

Forward-Looking StatementThis 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 the ability of the Company to finance its operations; 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; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations, including potential delays in clinical trial recruitment and participation. 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.

For more information:

AzurRx BioPharma, Inc.777 Yamato RoadSuite 502Boca Raton, Florida 33431Phone: (561) 589-7020info@azurrx.com

Media contact:

Tiberend Strategic Advisors, Inc.Johanna Bennett/Ingrid Mezo(212) 375-2665/(646) 604-5150jbennett@tiberend.com/imezo@tiberend.com

References:

¹ 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: 20202 New York Times. (5/20/21) https://www.nytimes.com/interactive/2020/world/coronavirus-maps.html3 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.pdf5 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.