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8-K - CURRENT REPORT - AzurRx BioPharma, Inc. | azrx8k_sep272017.htm |
Exhibit 99.1
AzurRx BioPharma and Mayoly-Spindler
Announce
Positive MS1819-SD Phase II Data in Exocrine Pancreatic
Insufficiency (EPI)
Brooklyn, NY –
(GLOBE NEWSWIRE) September 27, 2017 –
AzurRx BioPharma
Inc.(NASDAQ:
AZRX)
(“AzurRx” or the “Company”), today provided
an update on the first six 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.
Importantly, the company observed both clinical activity and a
clear dose response, where the highest MS1819-SD dose cohort showed
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 showed
favorable trends.
“We are encouraged by these Phase IIa data,” said Thijs
Spoor, CEO of AzurRx BioPharma. “They further confirm
the activity of MS1819-SD and also 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 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 $950 million in the U.S. and $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 800 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
Source: AzurRx BioPharma, Inc.