Proposed Phase 1b/2a clinical trial designed to determine safety and potential efficacy of oral and topical FW-420

BOCA RATON, Fla., Sept. 08, 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, announced today the submission of an Investigational New Drug (IND) Application seeking permission from the U.S. Food and Drug Administration (FDA) to begin a clinical trial evaluating proprietary formulations of niclosamide for Grade 1 and Grade 2 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors (ICIs).

The planned Phase 1b/2a clinical trial, now known as PASSPORT, is designed to determine the safety and potential efficacy of niclosamide, also known as FW-420, administered as an oral, immediate-release tablet and a topical rectal enema foam formulation. AzurRx is also currently investigating a proprietary formulation of micronized niclosamide (FW-1022) in a Phase 2 clinical trial (RESERVOIR) as a potential treatment for COVID-19-related gastrointestinal (GI) infections.

“We look forward to working with the FDA to advance the clinical development of FW-420 as a safe, effective and non-systemic treatment addressing immune checkpoint inhibitor-associated colitis (ICI-AC), a potentially dangerous side effect of cancer treatment involving immune checkpoint inhibitors,” stated James Sapirstein, President and Chief Executive Officer of AzurRx BioPharma.

Dr. James Pennington, Chief Medical Officer of AzurRx BioPharma added, “As many as 30 percent of patients treated with checkpoint inhibitors develop diarrhea that can progress to colitis, a condition that can be debilitating and, at times, life-threatening due to the compromised heath of the patient. We believe niclosamide has the potential to be the first drug specifically for ICI-AC and, thus, could become a critical component to the treatment regimen for cancer patients receiving immune checkpoint inhibitors.”

Mr. Sapirstein continued, “We are also excited by the potential to initiate a second clinical program involving micronized niclosamide. With our Phase 2 RESERVOIR trial investigating FW-1022 for COVID-19 related GI infections continuing to advance, we believe that niclosamide is ideally suited for addressing a number of GI conditions that are presently underserved and in need of innovation.”

About Immune Checkpoint Inhibitor-Associated Colitis
Immune checkpoint inhibitors (ICIs) are monoclonal antibodies that target down-regulators of the anti-cancer immune response and have revolutionized the treatment of a variety of malignancies. The global market for ICIs is significant; it was over $22 billion in 2019 and growing rapidly.Approximately 44% of patients with advanced cancer tumors (more than 260,000 patients) are eligible to receive immune checkpoint inhibitors.

However, many immune-related adverse events, especially diarrhea and colitis, limit their use.  The incidence of immune-mediated colitis (IMC) with diarrhea ranges from 1% to 30% depending on the type of ICI and whether they are used in combination.2The onset of diarrhea in ICI-AC patients occurs within 6-7 weeks after starting treatment and progressively worsens, and the progression to colitis is rapid and unpredictable. For example, in patients taking ipilimumab (Yervoy), between 25% and 30% of patients developed diarrhea and roughly 8% to 12% developed colitis proven by endoscopy.3 Moreover, the trend is towards the use of combination ICI therapies (e.g., Yervoy and Opdivo) and this will lead to a concomitant increase in both diarrhea and colitis.

Administration of corticosteroids, or treatment with certain immunosuppressive biologics, while withholding ICI therapy are recommended for Grade 2 or more severe colitis (National Cancer Institute 2020).  The impact of this colitis complication and treatment may reduce the goal of progression free cancer survival. An oral, non-absorbed treatment, such as niclosamide, for Grade 1 or 2 colitis with diarrhea may prevent progression to even more severe Grades of colitis. There currently is no approved treatment for Grade 1 colitis.

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.

About the PASSPORT Study
The PASSPORT clinical trial is a Phase 1b/2 trial to determine the safety, and potential efficacy of niclosamide in treatment of ICI-AC. The trial will be in two parts. Part 1 will study 12 patients with ICI-AC using oral niclosamide or oral plus niclosamide enemas, treated for two weeks. If deemed safe, Part 2 will study 90 patients in three arms (30 patients per arm), treated for two weeks. One arm will receive oral niclosamide three times daily, another arm will receive placebo three times daily. These two arms will be blinded. The third arm will employ oral niclosamide, three times daily, plus niclosamide enemas, twice daily. The primary efficacy endpoint for Part 2 will be time needed to resolve the diarrhea. Important secondary endpoints will be sparing of steroids, prevention of progression of disease and recurrence of diarrhea.

About FW-420
FW-420 is a niclosamide-based small molecule anti-inflammatory inhibitor therapy for the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and diarrhea in metastatic cancer patients.  FW-420 will be supplied in two formulations, as an oral immediate-release tablet and as a topical rectal enema foam. The standard care for treating inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn’s Disease, corticosteroids and 5-ASAs, can cause problems when used for check point inhibitor patients due to their immunosuppressant effects.  FW-420 has the potential to safely treat Grade 1 and Grade 2 ICI-associated colitis and diarrhea and prevent its progression to more serious and potentially fatal later stages. The overall goal of early niclosamide treatment is to enable oncology patients to remain on, or spend minimal time off, their ICI treatment programs without interruption.

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.

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
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Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
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References:
1 Immune Checkpoint Inhibitors Market, ResearchAndMarkets.com, 2020.
2 Wang et al. Patients with ICPI-induced diarrhea or colitis have improved survival outcomes. J Immunother Cancer. 2018; 6: 37. Som et al., World J Clin Cases. Feb 26, 2019; 7(4): 405-418
3 Wang DY, Ye F, Zhao S, et al. Incidence of immune checkpoint inhibitor-related colitis in solid tumor patients: a systematic review and meta-analysis. Oncoimmunology 2017; 10: e1344805; Som et al., World J Clin Cases. Feb 26, 2019; 7(4): 405-418


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