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AzurRx BioPharma, Inc. (AZRX)

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0.8400 -0.01 (-1.18%)
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Previous Close0.7943
Open0.8040
Bid0.8400 x 1100
Ask0.8483 x 2200
Day's Range0.7800 - 0.8599
52 Week Range0.5530 - 2.6300
Volume1,659,737
Avg. Volume9,931,390
Market Cap63.273M
Beta (5Y Monthly)1.66
PE Ratio (TTM)N/A
EPS (TTM)-1.4680
Earnings DateAug 13, 2019
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est3.50
  • AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment for Grade 1 Immune Checkpoint Inhibitor-Associated Colitis
    GlobeNewswire

    AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment for Grade 1 Immune Checkpoint Inhibitor-Associated Colitis

    Phase 1b/2a Study Expected to Begin In 2Q 2021DELRAY BEACH, Fla., April 13, 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 that it has entered into an agreement with PPD, Inc. (NASDAQ: PPD), a leading global contract research organization (CRO), for its planned Phase 1b/2a clinical trial evaluating proprietary formulations of micronized niclosamide for grade 1 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors (ICIs). Under the terms of the agreement, PPD will manage the Phase 1b/2a clinical trial using both oral immediate-release tablet and topical rectal enema foam formulations of micronized oral niclosamide, also known as FW-420. AzurRx anticipates initiating the trial during the second quarter of 2021. “The goal of our FW-420 clinical program is to develop a safe, effective, and non-systemic treatment for immune checkpoint inhibitor-associated colitis, and we are excited to once again partner with PPD to begin the preparations for our Phase 1b/2a clinical trial,” said James Sapirstein, President and CEO of AzurRx BioPharma. “The development of immune checkpoint inhibitors has marked a major advance in cancer therapeutics, but the drugs can induce a serious inflammation of the bowels, which if left unchecked, can prove life-threatening and force patients to halt treatment. There are currently no treatments available for grade 1 colitis resulting from the use of ICIs. We believe an oral, non-absorbed treatment, such as FW-420, could prevent the condition from progressing and enable patients to continue their treatment regimen uninterrupted. We hope to rapidly advance the FW-420 program with the support of PPD.” The agreement with PPD marks the second clinical trial involving niclosamide that the CRO will manage for AzurRx. As previously announced, PPD is also managing AzurRx’s Phase 2 clinical trial to investigate niclosamide as a treatment for COVID-19-related gastrointestinal infections, planned for the second quarter of 2021. Daniel Burch, M.D., Senior Vice President and Global Head of PPD® Biotech, stated, “We are pleased to have this opportunity to broaden our collaboration with AzurRx as it expands its clinical program for niclosamide to bring relief to patients suffering from immune checkpoint inhibitor-associated colitis. We look forward to utilizing our expertise and capabilities to advance the development of FW-420, beginning with the upcoming clinical trial.” About Immune Checkpoint Inhibitor-Associated ColitisImmune 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.1 Approximately 44% of patients with advanced cancer tumors (more than 260,000 patients) are eligible to receive immune checkpoint inhibitors.2 However, many immune-related adverse events, especially diarrhea and colitis, limit their use. The incidence of immune-mediated colitis (IMC) ranges from 1% to 25% depending on the type of ICI and whether they are used in combination used in combination.2 Approximately 30% of ICI patients develop diarrhea, which can progress to colitis. The onset of diarrhea in ICI-AC patients occurs within 6-7 weeks 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.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 colitis (diarrhea) may prevent progression to grade 2 disease. There currently is no approved treatment for grade 1 colitis. About NiclosamideNiclosamide 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 FW-420FW-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 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 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. 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 grade 1 Immune Checkpoint Inhibitor-associated colitis and diarrhea in oncology patients. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com. About PPD PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 26,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health. For more information, visit www.ppd.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 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 and current and planned clinical trials, 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.1615 South Congress AvenueSuite 103Delray Beach, Florida 33445Phone: (646) 699-7855info@azurrx.com Media contact: Tiberend Strategic Advisors, Inc.Johanna Bennett/Ingrid Mezo(212) 375-2665/(646) 604-5150jbennett@tiberend.com/imezo@tiberend.com 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): 405-4183 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

  • AzurRx BioPharma To Test Formulated Niclosamide In COVID-19-Related Gastrointestinal Infections
    Benzinga

    AzurRx BioPharma To Test Formulated Niclosamide In COVID-19-Related Gastrointestinal Infections

    AzurRx BioPharma Inc (NASDAQ: AZRX) has initiated Phase 2 RESERVOIR trial evaluating oral formulation of micronized niclosamide (FW-1022) for the treatment of COVID-19 related gastrointestinal (GI) infections. Patient enrollment is expected to begin soon, with topline data anticipated in Q1 2022. The Phase 2 trial is a two-part, two-arm, placebo-controlled study examining the safety and efficacy of FW-1022. This trial's two primary objectives will be to confirm the safety of niclosamide and demonstrate efficacy in clearing the SARS-CoV-2 virus from the GI tract. The trial's primary efficacy measure is the rate of fecal SARS-CoV-2 virus clearance (rectal swab or stool sample), comparing the niclosamide arm to the placebo arm for up to six months. Price Action: AZRX shares are trading 0.95% lower at $0.971 on the last check Tuesday. See more from BenzingaClick here for options trades from BenzingaAzurRx's Stock Falls After MS1819 For Pancreatic Insufficiency Flunks Mid-Stage Study© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • AzurRx BioPharma Initiates Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections
    GlobeNewswire

    AzurRx BioPharma Initiates Phase 2 Clinical Trial of Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections

    “RESERVOIR” trial to evaluate niclosamide’s ability to target SARS-CoV-2 in the GI tract Topline data expected in Q1 2022 DELRAY BEACH, Fla., April 06, 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 that it has initiated its Phase 2 RESERVOIR clinical trial of a proprietary oral formulation of micronized niclosamide (FW-1022) for the treatment of COVID-19 related gastrointestinal (GI) infections. Patient enrollment is expected to begin in April 2021 with topline data anticipated in Q1 2022. The Phase 2 RESERVOIR clinical trial is a two-part, two-arm, placebo-controlled study examining the safety and efficacy of micronized oral niclosamide tablets, known as FW-1022, in patients with COVID-19 GI infection. The two primary objectives of this trial will be to confirm the safety of niclosamide in the treatment of patients with COVID-19 GI infection and to demonstrate efficacy in clearing the SARS-CoV-2 virus from the GI tract. The primary efficacy measure of the RESERVOIR trial is the rate of fecal SARS-CoV-2 virus 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 previously announced, the trial will be managed by PPD, Inc. (NASDAQ: PPD), a leading global contract research organization (CRO). “Initiation of the Phase 2 clinical trial of FW-1022 for the treatment of COVID-19 GI infection, or the RESERVOIR trial, is a significant milestone for AzurRx and an important advance in the ongoing battle to help those infected by COVID-19 to overcome the often long-lasting effects of the virus,” said James Sapirstein, Chairman, CEO and President of AzurRx BioPharma. “COVID-19 is a pernicious disease and, despite the ongoing vaccine rollout, one that continues to impact hundreds of thousands of people worldwide every day in addition to the millions who have already been infected. For many, the after-effects of COVID-19 can be as bad as the disease itself, and this includes a growing number who experience severe GI complications due to what many believe is the ability of SARS-CoV-2 to hide in reservoirs within the GI tract. We believe micronized oral niclosamide has the potential to target SARS-CoV-2 directly in the gut and, doing so, become an important addition to the armamentarium of therapeutics that will unfortunately be required by many who contract COVID-19.” “So called ‘long haul COVID’ cases are becoming a major problem globally, and it is reasonable to expect the GI tract may serve as a silent reservoir,” added Dr. James Pennington, Chief Medical Officer of AzurRx. “We believe that niclosamide is ideally equipped to eradicate these hidden GI SARS-CoV-2 reservoirs due to its proven safety profile, known effectiveness in treating other GI ailments, and unique ability to remain in the gut for long periods of time. These properties, we believe, will be accentuated by our micronized formulation of niclosamide, which allows for local concentrations in the gut that exceed those needed to kill SARS-CoV-2. We look forward to testing this hypothesis in the RESERVOIR Phase 2 trial and reporting topline data from the trial in early 2022.” More information about this clinical trial is available at ClinicalTrials.gov. About Phase 2 RESERVOIR Clinical Trial The Phase 2 RESERVOIR clinical trial is a two-part, two-arm, placebo-controlled study examining the safety and efficacy of an immediate-release capsule formulation of micronized oral niclosamide, known as FW-1022, in patients with COVID-19 GI infection. The two primary objectives of this trial will be to show safety of niclosamide in treatment of patients with COVID-19 GI infection, and to show efficacy in clearing the SARS-CoV-2 (SARS2) virus from the GI tract. Part 1 of the trial will study 9 to 18 patients hospitalized with COVID-19 and GI positive stool or rectal swabs for SARS2. Patients will be treated for 14 days and observed closely for any signs of safety issues. A Data Monitoring Committee will then review the safety profile and if niclosamide is well-tolerated, the trial will move on to Part 2. Part 2 will be conducted in outpatients with COVID-19 and PCR positive stool or rectal swabs for SARS2. Patients will be randomized to either niclosamide, 400 mg tablets, three times a day, or placebo tablets three times a day. After 14 days of treatment, patients will be taken off study drugs and remain on study observation for up to 6 months. The primary efficacy measure of the trial is the rate of fecal SARS2 virus clearance (rectal swab or stool sample) assessed by RT-PCR, comparing the niclosamide arm to the placebo arm. Long term observation will also be important to indicate whether niclosamide treatment might improve ‘long haul’ COVID-19 symptoms. Approximately 100 patients will be studied in Part 2. An IND for the trial has been approved by the FDA, and the trial expects to begin enrolling patients in April 2021. Top line data are expected Q2 2021. About COVID-19 Gastrointestinal InfectionsGastrointestinal infection symptoms (severe diarrhea, vomiting and abdominal pain) have been reported in approximately 18% of COVID-19 cases1. Of the 26.6 million individuals who are reported to have contracted COVID-19 in the U.S., this would translate into 4.8 million patients having GI infection. Of the 105 million cases globally, it would translate into almost 19 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 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.2 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 will 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 Delray Beach, 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 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 and current and planned clinical trials, 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, 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 AvenueSuite 103Delray Beach, Florida 33445Phone: (646) 699-7855info@azurrx.com Media contact: Tiberend Strategic Advisors, Inc.Johanna Bennett/Ingrid Mezo(212) 375-2665/(646) 604-5150jbennett@tiberend.com/imezo@tiberend.com 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 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.