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

Rhea-AI Summary

AzurRx BioPharma, Inc. (NASDAQ: AZRX) announced the activation of seven new clinical trial sites in India for its Phase 2 RESERVOIR trial, aimed at evaluating the safety and efficacy of FW-1022, a niclosamide formulation for treating COVID-19-related gastrointestinal infections. This expands the total number of trial sites to 23, including locations in the U.S. and Ukraine. Topline results are expected in the first quarter of 2022. The trial targets SARS-CoV-2 clearance from the GI tract, addressing an urgent need in the ongoing pandemic.

Positive

• Activation of seven new trial sites in India expands total to 23, increasing recruitment potential.
• FW-1022 has shown antiviral activity with potency 40X greater than remdesivir.
• Topline results expected in Q1 2022 may demonstrate significant treatment potential for GI infections.

Negative

• Current COVID-19 infection rates in India average 38,000 daily, indicating a dire need for effective treatments.
• The trial faces challenges due to ongoing COVID-19 outbreaks and the presence of variants.

Phase 2 placebo-controlled clinical trial to confirm safety of FW-1022 and investigate its ability to remove SARS-CoV-2 virus from the GI tract

BOCA RATON, Fla., Sept. 10, 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 the activation of seven (7) new clinical trial sites in India for the ongoing RESERVOIR trial evaluating FW-1022. FW-1022 is a proprietary oral tablet formulation of micronized niclosamide developed for the treatment of COVID-19-related GI infections.

The seven new clinical trial sites in India, together with the existing eleven sites in the U.S. and the five trial sites recently added in the Ukraine, brings the total number of RESERVOIR trial sites to twenty-three. AzurRx expects to report topline results during the first quarter of 2022.

“Expanding our clinical trial into India provides access to the second most populous country in the world and one that, unfortunately, continues to experience a devastating COVID-19 outbreak,” said James Sapirstein, President and CEO of AzurRx BioPharma. “Despite the global vaccination effort, COVID-19, and the new Delta variant, remain pernicious. Infection rates in India average 38,000 a day with more than 31.1 million people infected overall. The virus’ impact on the GI tract is often overshadowed by its effect on the respiratory system, however COVID-19-related GI infection remains an undertreated symptom with devastating aftereffects. A safe and effective treatment that removes the virus from the gut is needed for the millions who have contracted and continue to fall victim to the virus.”

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, the virus that causes COVID-19, 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 are anticipated during the first quarter of 2022.

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.

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 drug 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 developed 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.

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. 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 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. (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.

FAQ

What is the purpose of AzurRx's RESERVOIR trial for FW-1022?

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

How many clinical trial sites are involved in the RESERVOIR trial?

There are currently 23 clinical trial sites for the RESERVOIR trial, including seven new locations in India.

When can we expect topline results from the RESERVOIR trial?

Topline results from the RESERVOIR trial are anticipated in the first quarter of 2022.

What are the primary objectives of the RESERVOIR trial?

The primary objectives are to confirm the safety of FW-1022 and evaluate its efficacy in clearing SARS-CoV-2 from the GI tract.

What is FW-1022 and how does it relate to COVID-19?

FW-1022 is a proprietary oral formulation of niclosamide developed to treat gastrointestinal infections caused by COVID-19.