Full Press Release Details
AzurRx BioPharma Announces Positive Preclinical Data with
is developing AZX1103 for the prevention of nosocomial infections
induced by administration of several classes of
shown to be safe and biologically active in a well-established
Brooklyn, NY (GLOBE NEWSWIRE) April 18, 2018 AzurRx
BioPharma Inc. (NASDAQ: AZRX) ( AzurRx or the
Company ), today announces positive preclinical
results for AZX1103, a -lactamase enzyme combination product being
developed for the prevention of hospital-acquired gastro-intestinal
AZ1103 is designed to be a complementary treatment for patients
receiving antibiotics in the hospital setting. The results from the
preclinical studies showed that AZX1103 had activity and degraded
amoxicillin in the presence of clavulanic acid in the upper GI
tract in the Gottingen minipig model.
The data from these studies are very encouraging, showing
AZ1103 to be safe and capable of inactivating amoxicillin, a member
of the widely used class of -lactam
antibiotics, said Thijs Spoor, CEO of AzurRx. We are
developing AZX1103 to prevent hospital acquired infections, such as
those caused by Clostridium difficile
(C. diff) and vancomycin resistant
enterococcus (VRE). The next
steps in this program will be to conduct toxicity studies in
animals with the goal of receiving the regulatory approvals to
The series of preclinical studies investigated oral delivery of
AZ1103 using three different capsule formulations:
immediate-release, enteric-delivery or colonic-delivery. In all
three formulations and at all doses tested, AZ1103 appeared to be
well tolerated. No side effects were observed and the animals
showed normal behavior, standard food consumption and body weight
gain. There was no evidence of acute toxicity, and no severe
immunoallergic reactions were seen at doses of up to 180mg/day. The
favorable safety profile is partly the result of AZ1103 not being
absorbed by the gut and entering the bloodstream. This property was
confirmed by ELISA testing, which did not detect
the enzyme in AZ1103 in the animal
About AZX1103, An Enzymatic Combination for Prevention of Hospital
-lactamase enzyme combination product
of bacterial origin for the prevention of hospital-acquired
infections (known as nosocomial infections) and
antibiotic-associated diarrhea (AAD) caused by resistant bacterial
strains induced by parenteral administration of several antibiotic
classes, including the -lactams. AZ1103 is not absorbed in the gut,
meaning that it will not disrupt the activity of antibiotics that
are being administered IV to treat severe infections. However,
AZ1103 can inactivate -lactam
antibiotics once they reach the large intestine, thus preventing
the harmful disruptions to the gut microbiome that lead to
The Centers for Disease Control, (CDC) has estimated that
approximately 1.7 million hospital-associated infections (i.e. ~5%
of the number of hospitalized patients), cause or contribute to
99,000 deaths each year in the U.S., with the annual cost ranging
from $4.5 - $11.0 billion.
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
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
LifeSci Advisors, LLC.
Hans Vitzthum, Managing Director
250 West 55th Street - Suite 16B
Source: AzurRx BioPharma, Inc.