AzurRx BioPharma Receives Approval to Conduct its Phase 2 OPTION 2 Clinical Trial of MS1819 in Cysti
On track to initiate the OPTION 2 trial by the end of Q2 2020
OPTION 2 trial to compare efficacy of standard of care to 2.2 and 4.4 gram doses of MS1819 in enteric capsules
Trial completion and top-line data expected in Q1 2021
NEW YORK, April 29, 2020 (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, today announced that the Company received approval to conduct of its Phase 2 OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI) in Therapeutics Development Network (TDN) clinical sites. The TDN is a collaborative network of CF clinical trial specialists supported by the Cystic Fibrosis Foundation (CFF). TDN support (formally called ‘sanction’ by the TDN) allows for access to 91 accredited U.S. care centers with established expertise in CF clinical research that facilitate recruitment and implementation of studies.
The Phase 2 multi-center study is designed to investigate the safety, tolerability and efficacy of MS1819 using 2.2 and 4.4 gram doses in enteric capsules head-to-head against the current standard of care, porcine pancreatic enzyme replacement therapy (PERT) pills. The study is expected to enroll 30 CF patients with target enrollment expected in Q4 2020 and study completion anticipated in Q1 2021.
“We are very pleased to receive the continued support of the Therapeutics Development Network for our Phase 2b OPTION 2 trial, which will allow for full study participation in the TDN sites,” said James Pennington, M.D., Chief Medical Officer of AzurRx. “We are optimistic that either the 2.2g or 4.4g dose of MS1819, in conjunction with the use of enteric capsules for delayed-release drug delivery, will enable us to successfully achieve our primary and secondary efficacy endpoints. A study conducted through the TDN provides a valuable platform for conduct of OPTION 2 in the U.S. and we look forward to beginning our enrollment.”
James Sapirstein, Chief Executive Officer of AzurRx, commented that “TDN approval is an important milestone for the Company and we look forward to initiating our OPTION 2 clinical trial in the CF patient population. Patients have expressed a desire for non-porcine derived alternatives to the current PERT therapies given ongoing safety and dietary concerns and now more recent concerns around availability given supply chain issues in China due to the COVID-19 pandemic and prior swine flus. We believe that our yeast-based recombinant enzyme therapy has the potential to become an effective and safer therapy for CF patients, with a more consistent and reliable manufacturing process and supply chain.”
MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.
About Exocrine Pancreatic Insufficiency
Exocrine Pancreatic Insufficiency (EPI) is a condition characterized by a deficiency of the pancreatic digestive enzymes in the intestinal tract needed to breakdown the nutrients in food so that they can be properly absorbed. This deficiency results in abdominal discomfort and pain, frequent bowel movements, steatorrhea, poor fat absorption, weight loss and chronic malnutrition. There are approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation, and more than 30,000 patients with EPI caused by CF according to the Cystic Fibrosis Foundation. The current therapeutic standard of care for these patients are porcine pancreatic enzyme replacement therapy (PERT) pills.
About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company engaged in the development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. 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. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation 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.
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