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AzurRx BioPharma Reports Second Quarter 2019 Financial Results and Provides Corporate Update | ||
By: Nasdaq / GlobeNewswire - 13 Aug 2019 | Back to overview list |
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On track to report top line data in Phase II OPTION Study in September 2019 NEW YORK, Aug. 13, 2019 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, reported financial results for the three and six months ended June 30, 2019 and highlighted recent corporate progress. Recent Corporate Progress
“AzurRx continues to make great strides in our clinical programs,” said Thijs Spoor, the CEO of AzurRx. “Our current Phase II OPTION Study of MS1819-SD is progressing as planned, we have not seen any serious adverse events and the withdrawal rates have been low, which is compatible with, or below, other trials of synthetic enzymes. We remain on track to announce final data analysis of the OPTION Study in September 2019. Last month, we announced that we initiated a Phase 2 clinical trial to investigate MS1819-SD in combination with PERT, the existing standard of care for treating severe EPI in CF patients. That trial will focus on the clinical needs of the third of patients whose nutritional requirements cannot be met with PERT alone and we expect to announce preliminary data in early 2020. Our goal is to address the needs of CF patients by exploring the efficacy of both MS1819-SD replacement and combination therapies.” During the second quarter, the Company announced that it acquired the intellectual property surrounding MS1819-SD. Mr. Spoor stated that, “Ownership of the patents to MS1819-SD further streamlines the project terms and more fully corresponds with our respective strategic and geographic objectives. We were also pleased to announce the Notices of Allowance in the U.S. and Japan for patents covering our MTAN inhibitor for treating H. pylori infections. We are excited to explore this indication as we believe that the MTAN technology has significant potential to reduce the number of H. pylori infections, and we plan to further develop the technology for narrow-spectrum anti-infectives against other diseases that have been prioritized by the WHO and the CDC. This expansion adds significant value to our portfolio of non-systemic, narrow spectrum therapeutic drugs that target gastrointestinal and bacterial infections and prevent dysbiosis in patients’ microbiomes.” “Finally, AzurRx is pleased to report that we completed a public offering in July 2019 resulting in gross proceeds of $5 million, which consisted of straight equity and no warrants or other convertible instruments,” Mr. Spoor added. Second Quarter 2019 Financial Results Second quarter 2019 research and development expense increased to $2.7 million from $926 thousand in the second quarter of 2018. The second quarter increase was primarily due to increased development activities both for the MS1819-SD OPTION trial in the United States and Poland and the initiation of the MS1819-SD combination therapy study in Hungary. General and administrative expense for the second quarter 2019 was approximately $2.2 million, compared with approximately $2.2 million in the second quarter of 2018. About MS1819-SD MS1819-SD, supplied as an oral non-systemic biologic capsule, is a recombinant enzyme that is derived from the Yarrowia lipolytica lipase, and unlike the PERT-based standard of care, does not contain any animal products. In a Phase 2 trial of MS1819-SD in patients with chronic pancreatitis, MS1819-SD showed a favorable safety profile with good tolerability. Additionally, a statistically significant (p=0.002) improvement in the coefficient of fat absorption of 21.8% was observed at the highest studied dose (per protocol). The Company is also currently conducting the OPTION Study, the Company’s Phase 2 multi-center study to investigate the safety, tolerability and efficacy of MS1819-SD in a head-to-head comparison against the current PERT standard of care for EPI in CF patients. The Company recently announced the completion of patient enrollment in the OPTION Study, with top-line results expected late Summer 2019. AzurRx also recently started a combination study of MS1819-SD and PERT in CF patients who are not adequately treated with PERT therapy. About Exocrine Pancreatic Insufficiency: EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in the inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss. AzurRx BioPharma, Inc. AzurRx BioPharma, Inc. (NASDAQ: AZRX) is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. MS1819-SD recombinant lipase for EPI is the Company's lead development program, and additional early stage research is being conducted for the prevention of hospital-acquired infections. The Company is headquartered in Brooklyn, New York, with scientific operations based in Langlade, France. Additional information on the Company can be found at www.azurrx.com. |
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Copyright 2019 Nasdaq / GlobeNewswire | Back to overview list |