Results on First Six Patients Expected in September
Company Adds Additional Clinical Trial Site to Further Support Enrollment in this Study and Other Planned Future Studies
BROOKLYN, N.Y., Aug. 23, 2017 (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, announced today that it has reached the 6th patient enrollment point in the ongoing 12-15 patient open-label Phase IIa trial of MS1819 for the treatment of exocrine pancreatic insufficiency (EPI) associated with chronic pancreatitis (CP), which is being conducted in partnership with Mayoly Spindler, a European pharmaceutical company. AzurRx expects to report data from the first six patients in this study in September 2017.
While enrollment in the Phase IIa trial has been slower than anticipated, in order to further support enrollment in both this study and other planned future trials, AzurRx has added an additional clinical site in Australia.
“We are pleased to reach this point in enrollment of this important clinical trial,” said Thijs Spoor, CEO of AzurRx BioPharma. The additional clinical site in Australia is expected to drive enrollment in both this study and other future planned clinical trials. Following the positive interim data we reported in the second quarter on the first three patients in the Phase IIa study, we look forward to the availability of additional results from the first six patients in September.”
AzurRx previously reported data from the first three patients enrolled in the Phase IIa trial in the second quarter of 2017. The results indicated that MS1819 is active, as measured by coefficient of fat absorption (CFA), which is the parameter being measured for the primary efficacy endpoint. There was a favorable dose response of greater than 20% improvement in CFA seen in all patients at either the second or third of the four escalating dosage levels of MS 1819. The product candidate also exhibited a favorable safety profile, with no moderate or severe adverse events having been reported.
MS1819 Phase IIa Trial
AzurRx is currently conducting a Phase IIa trial of MS1819 for the treatment of exocrine pancreatic insufficiency (EPI) associated with chronic pancreatic pancreatitis (CP). The study is being performed at four sites in Australia and New Zealand with a target enrollment of 12-15 patients. In addition to assessing safety, AzurRx is evaluating four escalating dose increments of MS1819, with the aim of elucidating the optimal treatment dose to be taken into subsequent registration trials in EPI patients with chronic pancreatitis (CP) and cystic fibrosis (CF). AzurRx continues to expect completion of this Phase IIa trial in the second half of 2017. Information about the trial can be found on the following website: http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ms1819&isBasic=True.
About MS1819, a Recombinant Lipase
MS1819, a recombinant lipase derived from the yeast Yarrowia Lipolytica, is in development for the treatment of exocrine pancreatic insufficiency (EPI) associated with chronic pancreatitis (CP) and cystic fibrosis (CF). Early Phase Ib data in EPI patients treated with MS1819 showed a favorable safety profile and encouraging preliminary signals of efficacy.
There are approximately 100,000 patients in the U.S. with EPI caused by CP according to the National Pancreas Foundation and more than 30,000 patients with EPI caused by CF according to the Cystic Fibrosis Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills. The U.S. market for such EPI porcine replacement therapy pills in 2016 was estimated to be approximately $950 million in the U.S. and $1.5 billion globally according to IMS data and Wall Street estimates.
AzurRx and Laboratoires Mayoly Spindler are party to a joint Research and development agreement and are collaborating on the development of a yeast derived recombinant lipase for the oral treatment of Exocrine pancreatic insufficiency (EPI). Under terms of their partnership agreement, AzurRx has marketing rights for the recombinant Lipase in various geographies, including exclusive rights for North America.
About Laboratoires Mayoly Spindler, SAS
Mayoly Spindler is a French, independent, family-owned pharmaceutical company, active in research, development, manufacturing, registration and marketing of pharmaceuticals and dermo-cosmetics in more than 70 countries. The company aims to become a global reference in gastroenterology and dermocosmetics. Mayoly Spindler is headquartered in the Paris area of France, and employs 800 people worldwide.
Mayoly Spindler website address: www.mayoly-spindler.com
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigations Reform Act of 1995. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the development and testing of our drug candidates, the regulatory approval process, our ability to secure additional financing, the protection of our patent and intellectual property, the success of strategic agreements and relationships, and the potential commercialization of any product we may successfully develop. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. For a discussion of such risks and uncertainties, see “Risk Factors” in AzurRx’s annual report on Form 10-K, its quarterly reports on Form 10-Q, and its other reports filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the dates on which they are made.