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8-K - CURRENT REPORT - AzurRx BioPharma, Inc. | azurrx8k_apr232018.htm |
Exhibit 99.1
AzurRx BioPharma and Mayoly-Spindler Announce Additional Positive
Interim Data for MS1819-SD Phase II in Exocrine Pancreatic
Insufficiency (EPI)
BROOKLYN, N.Y., April 23, 2018
(GLOBE NEWSWIRE) -- AzurRx BioPharma Inc.
(NASDAQ:AZRX) (“AzurRx” or the
“Company”), today provided an update on the first nine
treated patients in its ongoing Phase IIa trial of MS1819-SD, a
recombinant lipase, for the treatment of exocrine pancreatic
insufficiency (EPI) caused by chronic pancreatitis.
The
Company observed both clinical activity and a clear dose response,
where the highest MS1819-SD dose cohort continued to show greater
than 21% improvement in CFA (coefficient of fat absorption) in
evaluable patients. Additionally, maximal absolute CFA
response to treatment was up to 57%, with an inverse relationship
to baseline CFA. Favorable trends were also observed on other
evaluated endpoints, such as Bristol stool scale, number of daily
evacuations and weight of stool, and these were consistent with the
CFA results.
With
regard to safety, no serious adverse events or notable mild to
moderate events have been reported in the open-label, ascending
dose Phase IIa trial. Other markers relating to nutritional
status including patients’ plasma albumen were unchanged with
treatment. Similarly, fecal nitrogen assessments and nitrogen
output showed favorable trends.
“We
remain encouraged by this Phase IIa data as the results continue to
be consistently positive on both the intent to treat and per
protocol groups” said Thijs Spoor, CEO of AzurRx
BioPharma. “The data further confirms the activity of
MS1819-SD and demonstrate its dose response characteristics.
Additionally, secondary efficacy endpoints are consistently
aligning with the CFA data and the safety profile of MS1819-SD
remains favorable.”
Phase IIa Study
The
open-label, dose escalation Phase IIa study is being conducted in
France, Australia, and New Zealand and has been designed to enroll
12-15 patients with EPI caused by chronic
pancreatitis.
The
primary objective of the Phase IIa study is to investigate the
safety of escalating doses of MS1819-SD in patients with chronic
pancreatitis. The secondary objective is to investigate the
efficacy of MS1819-SD in these patients by analysis of the
coefficient of fat absorption and its change from baseline. Safety
is being assessed at the end of each treatment period with
particular attention paid to immunoallergic effects, digestive
symptoms and clinical laboratory tests.
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 $1.2 billion in the U.S. and over $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 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 on 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 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 900 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 regulatory approval process, the
development, testing, production and marketing of our drug
candidates, patent and intellectual property matters and strategic
agreements and relationships. 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
more Information:
AzurRx
BioPharma, Inc.
760
Parkside Avenue, Suite 304
Brooklyn,
NY 11226
Phone:
646-699-7855
www.azurrx.com
info@azurrx.com
IR
contact:
LifeSci
Advisors, LLC.
Hans
Vitzthum, Managing Director
250
West 55th Street - Suite 16B
New
York, NY 10019
Phone:
212-915-2568
www.lifesciadvisors.com
hans@lifesciadvisors.com