Full Press Release Details
AzurRx BioPharma To Present Interim Phase 2 Clinical Study Data for
MS1819-SD, in combination with standard PERT for Cystic Fibrosis
Patients with Severe Exocrine Pancreatic Insufficiency, at Biotech
Showcase 2020 Conference (January 13) in San Francisco
data from the first five patients indicate positive trends for all
primary and secondary safety and efficacy endpoints in
AzurRx's Phase 2 Clinical Study for MS1819-SD, in combination
with standard PERT for Cystic Fibrosis patients with severe
exocrine pancreatic insufficiency.
data underscore the potential of MS1819 to provide meaningful
clinical benefits to patients suffering from severe exocrine
pancreatic insufficiency (EPI) as an add-on therapy.
NEW YORK, January 9, 2020 (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 it will present
new data from five patients enrolled in its Phase 2 study for its
lead development candidate MS1819-SD at the 2020 Biotech Showcase
Conference being held at the Hilton San Francisco Union Square
Hotel (Yosemite C - Ballroom Level) on Monday, January
13th at 3:00 p.m. Pacific Time.
The Phase 2 clinical trial is designed to investigate the safety,
tolerability and efficacy of escalating doses of MS1819-SD, in
conjunction with a stable dose of PERTs, in order to increase the
coefficient of fat absorption (CFA) and relieve abdominal symptoms
in Cystic Fibrosis (CF) patients suffering from severe exocrine
pancreatic insufficiency (EPI). Patients enrolled in the
study continue to experience clinical symptoms of
fat malabsorption, despite efforts to control their
symptoms with commercially-available PERTs.
Data from the initial five patients showed positive trends
regarding the primary efficacy endpoint of CFA improvement with no
adverse events reported. Trends were also positive in the secondary
endpoints of improvements in body weight and stool consistency and
reductions in the number of bowel movements and the incidence of
steatorrhea. Additionally, multiple patients reported experiencing
less abdominal pain while being on the combination
Dr. James Pennington, Chief Medical Officer of AzurRx, will provide
an overview of the new data and the Company's clinical
development programs during a live presentation scheduled for 3:00
p.m. at the Biotech Showcase Conference. After the presentation,
Dr. Pennington and James Sapirstein, the Company's Chief
Executive Officer, will be available for one-on-one meetings with
investors registered for the conference.
About the MS1819-SD Combination Therapy Study
The digestive standard of care for both CF and chronic pancreatitis
(CP) patients with EPI are commercially-available PERTs. Ideally, a
stable daily dose of PERT will enable CF patients to eat a normal
to high-fat diet and minimize unpleasant gastrointestinal symptoms.
In practice, however, a substantial number of CF patients do not
achieve normal absorption of fat with PERTs(1,2).
Achieving an optimal nutritional status, including normal fat
absorption levels, in CF patients is important for maintaining
better pulmonary function, physical performance and prolonging
survival. Furthermore, a decline of body mass index around the age
of 18 years predicts a substantial drop in lung
The Phase 2 multi-center study is designed to investigate the
safety, tolerability and efficacy of escalating doses of MS1819-SD,
in conjunction with a stable dose of PERTs, in order to increase
the patient's CFA levels and relieve abdominal
symptoms. A combination therapy of PERT and MS1819-SD has the
potential to: (i) correct macronutrient and micronutrient
maldigestion; (ii) eliminate abdominal symptoms attributable to
maldigestion; and (iii) sustain optimal nutritional status on a
normal diet in CF patients with severe EPI. Planned enrollment is
expected to include approximately 24 CF patients with severe EPI,
with study completion anticipated in 2020.
MS1819-SD, supplied as an oral non-systemic biologic capsule, is a
recombinant enzyme that is derived from
lipolytica lipase, and
unlike the standard of care, does not contain any animal
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. This deficiency can be
responsible for greasy diarrhea, fecal urge and weight
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 cystic
fibrosis according to the Cystic Fibrosis Foundation. Patients are
currently treated with porcine pancreatic enzyme replacement
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-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
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