Blueprint AzurRx BioPharma Announces Successful Phase IIa Trial of MS1819-SD in Exocrine Pancreatic Insufficiency

AzurRx BioPharma Announces Successful Phase IIa Trial of MS1819-SD

in Exocrine Pancreatic Insufficiency

NEW YORK, June 29, 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, in partnership with Mayoly Spindler, a European

pharmaceutical company, the completion of its Phase IIa

MS1819-SD, a recombinant lipase, for the treatment of exocrine

pancreatic insufficiency (EPI) caused by chronic pancreatitis.

AzurRx expects to formally report the Phase IIa data in the Fall of

The primary objective of the open-label, multi-center, dose

escalation 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.

Initial data from the Phase IIa study shows a very strong safety

and efficacy profile. Both clinical activity and a clear dose

response have been observed, with the highest MS1819-SD dose cohort

continuing to show greater than 21% improvement in CFA 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,

including Bristol stool scale, number of daily evacuations and

weight of stool, and these were consistent with the CFA

The Company enrolled 11 of a planned 12 chronic pancreatitis

patients over the course of the Phase IIa trial. Due to a

sufficient efficacy and safety signal from the enrolled patients,

AzurRx will now focus on the treatment of EPI in the cystic

fibrosis setting with a planned Phase II trial in patients with

cystic fibrosis scheduled to begin in the second half of

We are very pleased that the MS1819-SD Phase IIa study has

been completed and that results to date show that MS1819-SD

succeeded in its safety and efficacy objectives, commented

Thijs Spoor, CEO of AzurRx. With our recent capital raise

and the addition of a clinical trial operations team with extensive

experience in late stage cystic fibrosis clinical studies, we are

very optimistic about the next phase of MS1819's clinical

development as a new therapy for patients suffering from cystic

The results obtained in all dosed patients are very

encouraging and confirm the safety and efficacy of

MS1819-SD, stated Dr. James Pennington, the Chief Medical

Officer of AzurRx. Based on these data, we believe we have

the basis for initiating a Phase IIb trial of MS1819 in cystic

fibrosis patients in the fall of 2018.

For more information on the Phase IIa study, refer to

ClinicalTrials.gov Identifier: NCT03481803.

About AzurRx BioPharma, Inc.

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

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

About Exocrine Pancreatic Insufficiency:

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 of greasy diarrhea, fecal urge

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 cystic fibrosis according

to the Cystic Fibrosis Foundation. Patients are currently treated

with porcine pancreatic enzyme replacement pills.

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

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 and final results of the Phase IIa

study, are contained in the Company's Annual Report of 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