Blueprint
Exhibit
99.1
AzurRx BioPharma Announces FDA Acceptance of IND Application for
Phase 2 Clinical Trial of MS1819-SD in Patients with Exocrine
Pancreatic Insufficiency Due to Cystic Fibrosis
On track to initiate Phase 2 trial in cystic fibrosis patients in
the fourth quarter of 2018 and conclude in 2019
NEW
YORK, Oct. 16, 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,
today announced that the United States Food and Drug Administration
(FDA) has cleared its Investigational New Drug (IND) application
for the Company’s lead asset, MS1819-SD, in patients with
exocrine pancreatic insufficiency (EPI) due to cystic fibrosis
(CF). The Company further announced that it plans to initiate
the multi-center Phase 2 study that was the subject of the IND in
the United States and Europe in the fourth quarter of 2018 and
expects it to conclude in 2019.
“FDA
clearance for our Phase 2 study of MS1819-SD in cystic fibrosis
patients represents a major milestone for the company,”
stated Thijs Spoor, CEO of AzurRx. “This approval
follows on the heels of our successful Phase 2a EPI trial in
patients with chronic pancreatitis (CP), which demonstrated both
safety and statistically significant efficacy. As previously
announced, MS1819-SD showed a statistically significant improvement
in the coefficient of fat absorption (CFA) of 21.8% at the highest
dose on a per protocol basis, which compares favorably with
historical data for the currently available porcine agents in
patients with chronic pancreatitis. As a result, we are
excited to move ahead with our planned phase 2 multi-center EPI
trial in patients with CF.”
Mr.
Spoor continued, “CF is a devastating illness with the
majority of patients requiring treatment from early childhood
onwards. Current treatments have a very high pill burden,
which often leads to non-compliance. Additionally, current
treatments utilize animal-based products which can carry inherent
risks, including transmission of pathogens and manufacturing/supply
chain inconsistency. In contrast, MS1819-SD could reduce a
patient’s pill burden and, since it is derived from yeast, we
believe the manufacturing process should be more scalable in larger
volumes. EPI in the U.S. alone is over a billion-dollar
market, and we believe MS1819-SD has the potential to become the
standard of care given its inherent advantages.”
“We
are moving forward aggressively with our plans for the phase 2
multi-center study in cystic fibrosis, which we expect will include
approximately 30 patients in a head-to-head test against the
current standard of care,” commented Dr. James Pennington,
Chief Medical Officer of AzurRx. “We expect to complete this
study in 2019 and look forward to reporting data shortly
thereafter.”
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 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 dermo-cosmetics.
Mayoly Spindler is headquartered in the Paris area of France and
employs 900 people worldwide. Additional information on the company
can be found at www.mayoly-spindler.com
About 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.
There
are approximately 90,000 patients in the U.S. with EPI caused by
chronic pancreatitis 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.
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.
Forward-Looking Statements
This press release may contain certain statements relating to
future results which are forward-looking statements. These
statements are not historical facts, but instead represent only the
Company’s belief regarding future events, many of which, by
their nature, are inherently uncertain and outside of the
Company’s control. It is possible that the Company’s
actual results and financial condition may differ, possibly
materially, from the anticipated results and financial condition
indicated in these forward-looking statements. Additional
information concerning the Company and its business, including a
discussion of factors that could materially affect the
Company’s financial results, including those related to the
clinical development of MS1819-SD and final results of the Phase
IIa study, are contained in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2017 under the
heading “Risk Factors,” as well as the
Company’s subsequent filings with the Securities and Exchange
Commission. All forward-looking statements included in this press
release are made only as of the date of this press release, and we
do not undertake any obligation to publicly update or correct any
forward-looking statements to reflect events or circumstances that
subsequently occur or of which we hereafter become
aware.
For more information:
AzurRx
BioPharma, Inc.,
760
Parkside Avenue
Suite
304
Brooklyn,
NY 11226
Phone:
(646)-699-7855
info@azurrx.com
Investor
Relations 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