AzurRx BioPharma Engages PPD to Handle Scientific Trial of Niclosamide for Remedy of Colitis Related to Grade 1 Immune Checkpoint Inhibitors Section 1b / 2a Examine Anticipated to Start in Q2 2021



DELRAY BEACH, Fla., April 13, 2021 (GLOBE NEWSWIRE) –AzurRx BioPharma Inc. (NASDAQ: AZRX), (“AzurRx” or the “Firm”), a clinical-stage biopharmaceutical firm specializing within the improvement of focused and non-systemic therapies for gastrointestinal (GI) illness, at present introduced that it has entered into an settlement with PPD, Inc. (NASDAQ: PPD), a number one international contract analysis group (CRO), for its deliberate Section 1b / 2a medical trial evaluating proprietary formulations of micronized niclosamide for grade 1 colitis and diarrhea in oncology sufferers handled with immune checkpoint inhibitors (ICI).

Underneath the phrases of the settlement, PPD will handle the Section 1b / 2a medical trial utilizing each immediate-release oral tablets and topical rectal enema foam formulations of micronized oral niclosamide, also referred to as FW-420. AzurRx plans to launch the trial within the second quarter of 2021.

“The objective of our FW-420 medical program is to develop a protected, efficient and non-systemic therapy for colitis related to immune checkpoint inhibitors, and we’re delighted to associate once more with PPD to start preparations for our section 1b / 2a medical trial, ”stated James Sapirstein, President and CEO of AzurRx BioPharma. “The event of immune checkpoint inhibitors marked a significant breakthrough in most cancers remedy, however medicine can induce extreme irritation of the intestines, which, if left unchecked, can show deadly and trigger extreme illness. sufferers to discontinue therapy. There’s presently no therapy accessible for grade 1 colitis ensuing from using ICI. We consider that an unabsorbed oral therapy, akin to FW-420, may stop the illness from progressing and permit sufferers to proceed their therapy with out interruption. We hope to advance the FW-420 program shortly with the help of PPD. “

The settlement with PPD marks the second niclosamide medical trial that the CRO will handle for AzurRx. As beforehand introduced, PPD can be operating the AzurRx Section 2 medical trial to check niclosamide as a therapy for gastrointestinal infections linked to COVID-19, scheduled for the second quarter of 2021.

Daniel Burch, MD, Senior Vice President and International Head of PPD® Biotech, stated: “We’re happy to have this chance to develop our collaboration with AzurRx because it expands its medical program for niclosamide to supply reduction to sufferers with checkpoint inhibitor-associated colitis. immune. We stay up for utilizing our experience and capabilities to advance the event of FW-420, beginning with the subsequent medical trial. “

About colitis related to immune checkpoint inhibitors
Immune Checkpoint Inhibitors (ICI) are monoclonal antibodies that concentrate on downregulators of the anti-cancer immune response and have revolutionized the therapy of assorted malignant tumors. The worldwide ICI market is giant; it exceeded $ 22 billion in 2019 and was rising quickly.1 About 44% of sufferers with superior most cancers tumors (over 260,000 sufferers) are eligible to obtain immune checkpoint inhibitors.2

Nevertheless, many immune-related opposed occasions, notably diarrhea and colitis, restrict their use. The incidence of immune mediated colitis (BMI) ranges from 1% to 25% relying on the kind of IBI and whether or not they’re utilized in mixture utilized in mixture.2 About 30% of ICI sufferers develop diarrhea, which might progress to colitis. The onset of diarrhea in ICI-AC sufferers happens inside 6 to 7 weeks and regularly worsens, and development to colitis is speedy and unpredictable. For instance, in sufferers taking ipilimumab (Yervoy), between 25% and 30% of sufferers developed diarrhea and about 8% to 12% developed colitis.3 As well as, the pattern is in the direction of using mixture ICI therapies (for instance, Yervoy and Opdivo), which is able to result in a concomitant enhance in diarrhea and colitis.

Administration of corticosteroids or therapy with sure immunosuppressive biologics, whereas stopping ICI therapy, is really useful for grade 2 or extra extreme colitis (Nationwide Most cancers Institute 2020). The influence of this complication and therapy for colitis could scale back the objective of progression-free most cancers survival. Unabsorbed oral remedy, akin to niclosamide, for grade 1 colitis (diarrhea) can stop development to grade 2 illness. There’s presently no accepted therapy for grade 1 colitis.

About niclosamide
Niclosamide is a small molecule prescription drug listed as a necessary drug by the World Well being Group (WHO). Niclosamide has been used safely in hundreds of thousands of sufferers for different medical indications. In america, niclosamide was accepted by america Meals and Drug Administration (FDA) in 1982 for the therapy of intestinal tapeworm infections. Along with its anthelmintic exercise, niclosamide has demonstrated anti-inflammatory and antiviral properties.

Concerning the FW-420
FW-420 is a niclosamide-based small molecule anti-inflammatory inhibitor remedy for the therapy of colitis related to immune checkpoint inhibitors (ICI-AC) and diarrhea in most cancers sufferers. metastatic. FW-420 can be equipped in two formulations, as a direct launch oral pill and as a topical rectal enema foam. Customary take care of the therapy of inflammatory bowel illness (IBD) akin to ulcerative colitis and Crohn’s illness, corticosteroids and 5-ASA, could cause issues when utilized in sufferers with an inhibitor checkpoint on account of their immunosuppressive results. FW-420 has the potential to securely deal with colitis and diarrhea related to grade 1 IBI and stop its development to extra critical and life-threatening later levels. The final objective of early therapy with niclosamide is to allow oncology sufferers to proceed or spend a minimal of free time of their ICI therapy applications with out interruption.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical-stage biopharmaceutical firm specializing within the improvement of focused non-systemic therapies for gastrointestinal (GI) illness. The Firm has a portfolio of three GI property topic to bowel restrictions. The principle therapeutic candidate is MS1819, a recombinant lipase for the therapy of pancreatic exocrine insufficiency (EPI) in sufferers with cystic fibrosis and power pancreatitis. AzurRx can be advancing two medical applications utilizing proprietary formulations of niclosamide, an inhibitor of the pro-inflammatory pathway: FW-1022, for gastrointestinal infections COVID-19 and FW-420, for colitis and diarrhea related to inhibitors. Grade 1 immune checkpoint in oncology sufferers. The corporate is headquartered in Delray Seaside, Florida, and medical operations in Hayward, California. For extra data go to www.azurrx.com.

About PPD
PPD is a number one international contract analysis group offering complete and built-in drug improvement, laboratory and lifecycle administration companies. Our shoppers embrace pharmaceutical, biotechnology, medical machine, tutorial and authorities organizations. With places of work in 47 international locations and greater than 26,000 professionals all over the world, PPD applies progressive applied sciences, therapeutic experience and a robust dedication to high quality to assist shoppers management the fee curve and improvement instances of medicines and to maximise the worth of offering life-changing therapies to enhance well being. For extra data go to www.ppd.com.

Ahead-looking assertion
This press launch could include sure statements referring to future outcomes that are forward-looking statements. It’s attainable that the precise outcomes and the monetary place of the Firm will differ, presumably considerably, from the anticipated outcomes and the monetary place indicated in these forward-looking statements, relying on elements, together with whether or not the outcomes obtained within the preclinical research and non-clinical and medical trials can be indicative. outcomes obtained in future medical trials; whether or not the preliminary or interim outcomes of a medical trial can be indicative of the ultimate trial outcomes; and the influence of the coronavirus pandemic (COVID-19) on the corporate’s operations and ongoing and deliberate medical trials, together with potential delays in recruitment and participation in medical trials. Further data relating to the corporate and its actions, together with an evaluation of things that might have a cloth influence on the monetary outcomes of the corporate, is contained within the annual report of the corporate on Kind 10-Okay for the yr ended. December 31, 2020 beneath the heading “Threat elements”. in addition to the corporate’s subsequent filings with the Securities and Trade Fee. All forward-looking statements included on this press launch are made solely as of the date of this press launch, and we don’t undertake any obligation to publicly replace or appropriate any forward-looking statements to mirror occasions or circumstances that come up. subsequently happen or of which we change into conscious later.

For extra data:

AzurRx BioPharma, Inc.
1615 South Congress Avenue
Workplace 103
Delray Seaside, Florida 33445
Phone: (646) 699-7855
information@azurrx.com

Media contact:

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

1 Immune Checkpoint Inhibitors Market, ResearchAndMarkets.com, 2020.
2 Wang et al. Sufferers with diarrhea or ICPI-induced colitis have higher survival outcomes. J Immunother Most cancers. 2018; 6:37. Som et al., World J Clin Instances. Feb 26, 2019; 7 (4): 405-418
3 Wang DY, Ye F, Zhao S et al. Incidence of colitis related to immune checkpoint inhibitors in sufferers with stable tumors: a scientific overview and meta-analysis. Oncoimmunology 2017; 10: e1344805; Som et al., World J Clin Instances. Feb 26, 2019; 7 (4): 405-418

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