AzurRx Provides Update on MS1819 Phase II Trial
11 April 2017 - 10:00PM
Initial patient experience shows no safety
issues
AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“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.
Early 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.
These 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.
Thijs 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).”
Dr. 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
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). 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 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 750
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.
CONTACT: For more Information:
AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 217
Brooklyn, NY 11226
Phone: 646.699.7855
http://www.azurrx.com info@azurrx.com
Laboratories Mayoly Spindler
6 Avenue de l'Europe
B.P. 51 - 78401
CHATOU Cedex - France
Phone: +33(0)1 34 80 57 00
Fax: + 33(0)1 34 80 41 11
http://www.mayoly-spindler.com contact@mayoly.com
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