AzurRx SAS

First Wave Biopharma has signed CRO Rho to run a phase 2 trial for the biopharma’s treatment for exocrine pancreatic insufficiency that is expected to launch by the end of the year. First Wave Biopharma has inked a deal for Rho to run a phase 2 trial of the biopharma’s treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and chronic pancreatitis. First Wave’s adrulipase is an oral recombinant lipase enzyme that is designed to break up fat molecules in the digestive tract of EPI patients so the molecules can be absorbed as nutrients. According to the Cystic Fibrosis Foundation, more than 30,000 people in the U.S. suffer from EPI caused by cystic fibrosis, and the National Pancreas Foundation estimates about 90,000 patients in the country have EPI caused by chronic pancreatitis. Rho has managed prior clinical programs involving adrulipase. The latest trial is expected to begin by the end of the year, First Wave said in an Oct. 31 press release. Financial terms weren’t disclosed. “Research, including data recently presented at AAPS 2022, indicates the new adrulipase formulation should deliver the drug in the intended area of the gastrointestinal tract,” First Wave CEO James Sapirstein said in the release. Just over a year ago, AzurRx acquired First Wave and took on its name in a cash-and-stock deal valued at up to $229 million.

Florida-based AzurRx BioPharma is bolstering its gastrointestinal disease pipeline with the $229 million acquisition of First Wave Bio and its small molecule therapeutics for auto-immune inflammatory bowel diseases (IBD) and other serious conditions this morning. The move positions the company to carve out a significant slice of the IBD market share. Following the deal's completion, AzurRx will change its name to First Wave BioPharma, Inc., and the company’s shares will trade on the Nasdaq under the ticker symbol “FWBI.” AzurRx currently trades under the symbol AZRX. This morning, share prices are up slightly to $5.50 in premarket trading after closing at $5.45 on Friday. Trading under the new name is expected to begin on Sept. 23. A new company website will also be launched at . The company leadership will remain the same despite the rebranding, with James Sapirstein remaining as chairman, president, and chief executive officer. News of the acquisition was announced three days after AzurRx said the Independent Data Monitoring Committee approved the initiation of enrollment for the second part of the ongoing RESERVOIR Phase II study of FW-1022 as a potential treatment for gastrointestinal infections related to COVID-19. FW-1022 is a proprietary, oral tablet formulation of micronized niclosamide, which had been licensed from First Wave Bio in January. Merging the First Wave portfolio will bring new assets aimed at IBD indications in ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS), ulcerative colitis (UC), and Crohn’s disease (CD) into the AzurRx arsenal. AzurRx will own all rights to First Wave Bio’s proprietary formulations of niclosamide, a small molecule drug that features anti-viral and anti-inflammatory properties designed to address multiple GI conditions. Additionally, AzurRx will own First Wave Bio’s intellectual property (IP) portfolio, which covers the method of use and delivery of these formulations. Sapirstein called the acquisition and rebranding a “transformative event” for AzurRx. The deal significantly expands the company’s GI development pipeline and puts the company in a position for new growth opportunities in the therapeutic space of inflammatory bowel disease. With the addition of the First Wave assets for multiple IBD indications, Sapirstein added that it represents “multi-billion dollar commercial market opportunities.” The IBD patient population is expected to grow over the next decade. “We believe that our proprietary formulations of niclosamide, with their novel anti-inflammatory mechanism of action, non-systemic absorption, and safety benefits, will enable us to address significant unmet clinical needs for IBD patients, especially in the mild-to-moderate disease categories. With our expanded pipeline and new IBD indications, we expect strong growth and increased shareholder value,” Sapirstein said. James Pennington, chief medical officer of AzurRx, noted that data recently generated by First Wave in ulcerative proctitis supported the broader potential for niclosamide in that indication, as well as other IBDs. Pennington said that data led to the idea that AzurRx’s niclosamide formulations could offer significant advantages over other currently available treatments in the mild-to-moderate disease stage. “Specifically, our niclosamide formulations are orally delivered, are targeted specifically to the areas of the GI tract where the disease-causing inflammation occurs, and avoid the risk of steroid-related immunosuppressant complications. Additionally, the manufacturing process for our niclosamide products can be scaled up to supply large populations quickly.” Pennington said in a statement.

BOCA RATON, Fla., Sept. 07, 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 that James Sapirstein, Chief Executive Officer of AzurRx, will present virtually at the H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021. The prerecorded presentation will be available starting at 9:00 a.m. ET on September 13, 2021 and can be accessed via the conference’s virtual platform by registered conference attendees. During the presentation, Mr. Sapirstein will provide an overview of AzurRx’s business and clinical development programs and discuss anticipated 2021 and early 2022 milestones. Additionally, Mr. Sapirstein and members of the AzurRx management team will participate in virtual one-on-one meetings with registered investors and pharmaceutical company executives. Details of the presentation are as follows: 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 . 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; 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 502Boca Raton, FL 33431Phone: (561) 589-7020info@azurrx.com Media contact:Tiberend Strategic Advisors, Inc.Johanna Bennett / David Schemelia(212) 375-2665 / (609) 468-9325jbennett@tiberend.com / dschemelia@tiberend.com