Attached files
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| 8-K - CURRENT REPORT - AzurRx BioPharma, Inc. | azurrx8k.htm |
| EX-99.1 - CORPORATE PRESENTATION - AzurRx BioPharma, Inc. | ex99-1.htm |
Exhibit
99.2
AzurRx BioPharma Announces Enrollment of Three New Patients
for its Phase IIa Study of MS1819-SD
In conjunction with already identified patients in France, the
company expects to complete enrollment in first half of
2018
BROOKLYN, N.Y., Feb. 12, 2018 (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 in
partnership with Mayoly Spindler, a French pharmaceutical
company, it has enrolled three new patients to its phase IIa
study of MS1819-SD for patients with exocrine pancreatic
insufficiency (EPI) caused by chronic pancreatitis (CP).
Patients were enrolled at sites in Australia and with an enrollment
target of 12-15 patients, this brings the total number of patients
dosed in the trial to nine.
The primary objective of this Phase II study is to investigate the
safety of escalating doses of MS1819-SD in patients with CP. The
secondary objective is to investigate the efficacy dose response of
MS1819-SD in these patients by analysis of the coefficient of fat
absorption (CFA) and its change from baseline. Safety will be
assessed at the end of each treatment period with particular
attention paid to immunoallergic effects, digestive symptoms and
clinical laboratory tests.
“We are very pleased that our existing clinical sites have
recruited these new patients. After a rapid clearance of the
Investigational Medicinal Product Dossier (IMPD) for our site in
France (La Timone Hospital, Marseille), we believe have now
identified enough potential patients to complete enrollment of the
study in the first half of 2018, in line with previously published
guidance,” said Thijs Spoor, CEO of AzurRx
BioPharma.
MS1819-SD, an oral non-systemic biologic capsule, is a recombinant
enzyme that is derived from the yeast
strain Yarrowia
lipolytica, and is entirely
plant-based/vegan. In early animal and human trials, it
demonstrated an appropriate profile to compensate the pancreatic
lipase (enzyme) deficiency that is common with CP patients. The
deficiency of this enzyme can be responsible for greasy diarrhea,
fecal urge and weight loss.
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 2017 was estimated to be
approximately $1.1 billion in the U.S. and $1.6 billion globally
according to IMS data and Wall Street estimates.
About 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 recombinant lipase for exocrine pancreatic
insufficiency 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, NY, with scientific operations based in
Langlade, France. Additional information regarding the Company
can be found at www.azurrx.com.
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
dermocosmetics 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 900 people worldwide.
Mayoly Spindler website address: www.mayoly-spindler.com
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About Exocrine Pancreatic Insufficiency:
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.
About MS1819
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 standard of care, does not contain any animal
products. In an animal model, the in-vivo activity of MS1819
was superior to the activity seen in-vivo using the standard of
care porcine pancreatic extracts. A previous study has found
that MS1819 was well tolerated in humans with no serious adverse
events.
Information about the trial can be found on the following
website:
http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ms1819&isBasic=True
Forward-Looking Statements:
The statements in this press release that are not historical facts
may constitute forward-looking statements that are based on current
expectations and are subject to risks and uncertainties that could
cause actual future results to differ materially from those
expressed or implied by such statements. Those risks and
uncertainties include, but are not limited to, risks related to the
successful continuation and results of the Company’s phase
IIa clinical study of MS1819-SD, allowance of patent applications
and continued protection of its intellectual property, and the
availability of substantial additional capital to support its
operations, including the phase IIa clinical development activities
described above. These and other risks and uncertainties are
identified and described in more detail in the Company’s
filings with the Securities and Exchange Commission (SEC). These
filings are available on the SEC’s website
at www.sec.gov.
The Company undertakes no obligation to publicly update or revise
any forward-looking statements.
CONTACT:
For more Information:
AzurRx BioPharma, Inc.
760 Parkside Avenue,
Suite 304
Brooklyn, NY 11226
Phone: 646.699.7855
http://www.azurrx.com
info@azurrx.com
For more Information:
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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