AzurRx BioPharma, Inc.
Exhibit 99.1
AzurRx BioPharma Exceeds 50% Enrollment Target for Phase II OPTION
Clinical Trial
●
Enrollment in AzurRx’s Phase II OPTION study passes 50%
enrollment target
●
Initial top line data of MS1819-SD in Cystic Fibrosis
Patients expected in Summer 2019
NEW YORK, April 23,
2019 (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 it has now surpassed the 50%
enrollment target in its ongoing Phase II OPTION study of MS1819-SD
for exocrine pancreatic insufficiency in patients with cystic
fibrosis (CF).
The
Phase II multi-center OPTION study is designed to investigate the
safety, tolerability and efficacy of MS1819-SD in a head-to-head
comparison against the current porcine pancreatic enzyme
replacement therapy (PERT) standard of care for exocrine pancreatic
insufficiency in CF patients. Planned enrollment is expected
to include approximately 30 CF patients, with top-line results
expected in Summer 2019.
Thijs
Spoor, Chief Executive Officer of AzurRx, commented, “The
AzurRx team is very pleased to have reached the half-way mark of
enrollment in our OPTION study of MS1819-SD. This represents an
important milestone for AzurRx and demonstrates that we are on
track to complete enrollment by mid-2019. Once again, we would like
to thank both the participating patients and our clinical
collaborators for insuring successful study
progression.”
About OPTION
The
OPTION study is a Phase II, open-label, multicenter, 2x2 crossover
study assessing the safety and efficacy of MS1819-SD versus porcine
PERT when given at the same dose that was administered during the
pre-study period. Approximately 30 evaluable CF patients will
complete both crossover periods. The primary efficacy
endpoint will be a comparison of the coefficient of fat absorption
(CFAs) after each of the two crossover periods.
Additional
information about the ongoing OPTION MS1819-SD can be found
at https://clinicaltrials.gov/ct2/show/NCT03746483?term=ms1819&rank=2.
About MS1819-SD
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.
About Exocrine Pancreatic Insufficiency (EPI):
EPI is
a condition characterized by deficiency of the
exocrine pancreatic enzymes, resulting in the inability
to digest food properly, or maldigestion. This deficiency 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.
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-SD recombinant lipase for
EPI 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.
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 II
OPTION study, are contained in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2018, filed with the
Securities and Exchange Commission on April 1, 2019, 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:
617-535-7743
www.lifesciadvisors.com
hans@lifesciadvisors.com