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NEW YORK, October 14, 2020 (GLOBE NEWSWIRE) – AzurRx BioPharma, Inc. (NASDAQ: AZRX) (“AzurRx” or the “Company”), a company specializing in the progression of recombinant treatments without formula for diseases of the gastrointestinal formula, announced that it has activated two trial sites in Turkey for its phase 2 combination therapy clinical trial to investigate MS1819 in cystic fibrosis (FK) patients with severe pancreatic insufficiency (in total, 8 of the 12 expected sites in Europe are now active and recruit patients.
“In fact, we are very happy and encouraged by the interest generated through the expansion of our global Phase 2 mixing trial,” said Dr. James Pennington, AzurRx’s medical director. “Recently published provisional knowledge suggests promising effects and a full reading of knowledge is expected at the time of next year. Our researchers in Turkey have been incredibly diligent in getting the start of this essay in a very effective and effective way, and we look forward to continuing our paintings. “
Related to the MS1819 Combination Therapy Study The popular digestive treatment for patients with cystic fibrosis and chronic pancreatitis (CP) with PPE is commercially available swine pancreatic enzyme (PERT) replacement therapy. Ideally, a solid daily dose of PERT will allow cystic fibrosis patients to follow high-fat nutrition and minimize unpleasant gastrointestinal symptoms. In practice, however, a significant number of cystic fibrosis patients do not achieve general absorption of FATs with PERT (1. 2). Obtaining optimal nutritional status, adding General fat absorption levels, in patients with cystic fibrosis, is vital to maintain increased lung function, physical functionality and prolong survival. 3. 4).
A mixed treatment of PERT and MS1819 has the potential to: (i) adequate poor digestion of macronutrients and micronutrients; (ii) eliminate abdominal symptoms due to poor digestion; and (iii) optimal nutritional prestige with general nutrition in patients with cystic fibrosis with severe PPE. Planned recruitment is expected to be approximately 24 patients with cystic fibrosis with severe PPE, and the examination is expected to be completed in the quarter of 2021.
About MS1819 MS1819 is a recombinant lipase enzyme for the remedy for exocrine pancreatic insufficiency related to cystic fibrosis and chronic pancreatitis. MS1819, which comes in the form of a non-systemic oral biological capsule, is derived from Yarrowia lipolytic yeast lipase and breaks down fat molecules in the digestive tract of PPE patients so that they can be absorbed as nutrients. Unlike popular care, MS1819 artificial lipase does not contain animal products.
With regard to exocrine pancreatic insufficiency, PPE is a condition characterized by a deficiency of exocrine pancreatic enzymes, which results in the patient’s inability to digest food well or poor digestion. Deficiency of this enzyme could be the cause of fat diarrhea, fecal desire and weight loss.
There are more than 30,000 patients in the United States with cystic fibrosis PPE according to the Cystic Fibrosis Foundation and about 90,000 patients in the United States with CHRONIC pancreatitis ANEP according to the National Pancreas Foundation. update the swine pancreatic enzyme.
AzurRx BioPharma, Inc. AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company that specializes in the studies and progression of non-systemic biological products for gastrointestinal disorders. The company aims to present its main candidate drug, MS1819. AzurRx is currently conducting two phase 2 clinical trials of MS1819: the OPTION 2 monotreation trial and the combination treatment trial, consisting of MS1819 along with a swine pancreatic enzyme replacement treatment, the popular existing treatment. NY, with clinical operations in Hayward, California. Se can obtain additional data about the company in www. azurrx. com.
Forward-Looking Statements This press release may contain certain forward-looking statements regarding long-term effects that are forward-looking statements. These statements are not old facts, but rather constitute the confidence of the company in relation to long-term occasions, many of which, by their nature, are inherently unsafe and beyond the control of the company. It is conceivable that the Company’s actual effects and monetary position will differ, in all likelihood significantly, from the expected effects and monetary position shown in those forward-looking statements, adding whether the effects received in preclinical and non-clinical studies and clinical trials will be indicative of effects received in long-term clinical trials; whether the initial or intermediate effects of a clinical trial, such as the intermediate effects presented, will be indicative of the final effects of the trial. Additional data about the Company and its activities, adding an investigation of points that may also have a drapery effect on the Company’s monetary effects, adding those similar to the clinical progression of MS1819, the effects of its clinical trials and having a effect on coronavirus pandemic (COVID-19) on company operations and ongoing and planned clinical trials, adding, but not limited to, delays in recruitment and participation in clinical trials are included in the report Company’s annual report on Form 10-K for the fiscal year ended December 31, 2019 under the heading “Risk Factors”, as well as the Company’s upcoming 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 assume any legal responsibility to publicly update or appropriate forward-looking statements to reflect upcoming events or occasions or that we now we realize.
For information:
AzurRx BioPharma, Inc. 760 Parkside Avenue, Suite 304 Brooklyn, NY 11226 Phone: (646)-699-7855info@azurrx. com
Investor Relations Contact:
LifeSci Advisors, LLC. Hans Vitzthum, General Manager 1 International Place, Suite 1480 Boston, MA 02110 Phone: 617-430-7578 hans@lifesciadvisors. com
References (1) Freedman, SD, Am. J. Manag. Care, 2017; 23: S2220-S228 (2) Littlewood, J. et al, 2006, Pediatric pneumology, 2006, 41: 35-49 (3) Engelen, M. et al, 2014, Curr. Opin. Clin. Nutr. Metab. Se concern; 17 (6): 515-520 (4) Vandenbranden, S. L. et al, 2012, Pediatric Pneumology, 2012; (2): 135-143
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