AzurRx BioPharma Adds New Clinical Trial Sites in Ukraine for Phase 2 RESERVOIR Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections

Rhea-AI Summary

AzurRx BioPharma has expanded its RESERVOIR Phase 2 clinical trial for FW-1022, targeting COVID-19-related gastrointestinal infections, by adding five new sites in Ukraine. The study aims to evaluate the safety and efficacy of FW-1022, a micronized niclosamide formulation, in clearing SARS-CoV-2 from the GI tract. With COVID-19 symptoms reported in 18% of cases, the trial could provide insights into potential treatments for long-term effects of COVID. Topline data is expected in Q1 2022. The increasing vaccination gap in Ukraine strengthens the trial's patient recruitment potential.

Positive

• Addition of five new clinical trial sites in Ukraine enhances patient recruitment opportunities.
• FW-1022 is expected to address a crucial gap in treatments for COVID-19-related GI infections.
• Topline data from the RESERVOIR trial is anticipated by Q1 2022, potentially advancing treatment options.

Negative

• The trial's success is uncertain, relying on the efficacy of FW-1022 against COVID-19-related GI infections.
• Low vaccination rates in Ukraine may lead to ethical concerns regarding patient recruitment.

BOCA RATON, Fla., Aug. 10, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today announced the completion of site initiation visits and the addition of five (5) new clinical trial sites in Ukraine for 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 for the treatment of COVID-19-related GI infections.

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 (stool sample) assessed by RT-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. Topline data from the study is anticipated during the first quarter of 2022.

“Niclosamide represents an important advance in the fight to help COVID-19 patients overcome the debilitating and often overlooked effect the virus can have on the GI system,” said James Sapirstein, Chairman, CEO and President of AzurRx BioPharma. “While vaccines have been delivered to millions of people, COVID-19, and, in particular, the highly infectious Delta variant, remains a significant concern, especially in regions of the U.S. and areas of the world where vaccination rates are low. The addition of new trial sites in Ukraine provides enhanced opportunity to enroll patients in a country where less than 5% of the population is fully vaccinated for COVID-19.”

“FW-1022 is an orally delivered, non-systemic formulation of niclosamide that is designed to deliver high concentrations of the drug directly to the GI tract,” said Dr. James Pennington, Chief Medical Officer of AzurRx BioPharma. “We believe these properties have the potential to decrease viral load and GI-associated symptoms of COVID and look forward to accelerating the progress of the RESERVOIR trial to, hopefully, introduce the first therapeutic specifically designed to treat COVID GI infections.”

Additional information about the RESERVOIR trial can be found at the www.covidgi.com website and on ClinicalTrials.gov.

The RESERVOIR trial is being managed by PPD, Inc., a leading global contract research organization (CRO). AzurRx is also developing a proprietary formulation of micronized niclosamide (FW-420) as a treatment for immune checkpoint inhibitor-associated colitis.

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 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 pro-inflammatory pathway inhibitor: FW-1022, for COVID-19 gastrointestinal infections and FW-420, for grades 1 and 2 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 http://www.azurrx.com/.

Forward-Looking Statement
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. These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the public offering, the satisfaction of customary closing conditions related to the public offering and the intended use of proceeds from the public offering. 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 risks and uncertainties related to market conditions; 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, 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, 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 Road
Suite 502
Boca Raton, FL 33431
Phone: (561) 589-7020
info@azurrx.com

Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett / David Schemelia
(212) 375-2665 / (609) 468-9325
jbennett@tiberend.com / dschemelia@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: 2020
² New York Times. (7/1/21) https://www.nytimes.com/interactive/2020/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.

FAQ

What is the purpose of the RESERVOIR Phase 2 clinical trial for AZRX?

The RESERVOIR trial aims to evaluate the safety and efficacy of FW-1022 in treating COVID-19-related gastrointestinal infections.

When is the expected topline data release for the FW-1022 trial?

Topline data from the RESERVOIR trial is expected in the first quarter of 2022.

What are the implications of adding clinical trial sites in Ukraine for AZRX?

The addition of new trial sites in Ukraine enhances the potential for patient enrollment, especially in a region with low COVID-19 vaccination rates.

What are the expected outcomes of using FW-1022 for COVID-19-related GI infections?

FW-1022 aims to clear SARS-CoV-2 from the GI tract and may provide treatment for long-term COVID-19 symptoms.