Full Press Release Details
AzurRx Provides Update on MS1819 Phase II Trial
Initial patient experience shows no safety issues
MS1819 appears active, as demonstrated by CFA increases >20% at
various dosing levels
N.Y., April 11, 2017 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc.
( AzurRx or the Company ), a company
specializing in the development of non-systemic, recombinant
therapies for gastrointestinal diseases, today is providing an
update on the ongoing open-label Phase IIa trial of lead candidate
MS1819 for the treatment of exocrine pancreatic insufficiency (EPI)
associated with chronic pancreatitis (CP). The trial is being
conducted in partnership with Mayoly Spindler, a European
pharmaceutical company.
results indicate that MS1819 exhibits a favorable safety profile,
with no moderate or severe adverse events having been reported to
date. Additionally, no patients have dropped out of the study once
they have qualified to take the active drug. Regarding efficacy,
results to date indicate 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.
early efficacy and favorable safety results from the ongoing Phase
IIa trial confirm data from the previously performed Phase Ib trial
of MS1819. The company expects study completion in the
third-quarter of 2017.
Spoor, CEO of AzurRx BioPharma, said We are extremely
encouraged by these early Phase IIa MS1819 data, observing a clear
dose-response pattern with clean safety characteristics. We
continue to expect MS1819 to show a superior efficacy, safety, and
dosing profile relative to the currently marketed pancreatic enzyme
replacement therapies (PERT).
Richard Stubbs, Managing Director of P3 Research, in Wellington,
New Zealand and Clinical Investigator said Our patient
satisfaction is very high in this study as underscored by an
expressed interest in joining in further studies of MS1819.
Physician response has also been favorable. We are delighted to
play a key role in developing products that have significant
potential to change patient care.
MS1819 Phase IIa Trial
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). The primary efficacy
endpoint is the change in CFA from baseline and measured at the end
of the open label treatment part of the trial (Phase C) on
standardized high-fat meals and stool collection for 3 days. AzurRx
continues to expect completion of this Phase IIa trial in 3Q17.
Information about the trial can be found on the following
About MS1819, a Recombinant Lipase
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
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.
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
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 750
Spindler website address: www.mayoly-spindler.com
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