AzurRx BioPharma to Report Topline Data from Phase 2b OPTION 2 Clinical Trial of MS1819 in Cystic Fibrosis
March 31 2021 - 4:01PM
AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”),
a clinical stage biopharmaceutical company specializing in the
development of targeted, non-systemic therapies
for gastrointestinal (GI) diseases, announced today that the
Company will host a conference call and live audio webcast today,
Wednesday, March 31, 2021, at 4:30 p.m. ET, to discuss the topline
results from its Phase 2b OPTION 2 clinical trial investigating
MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic
insufficiency (EPI).
Interested participants and investors may access
the conference call by dialing either:
-
(833) 607-1647 (U.S.)
-
(914) 987-7760 (international)
-
Conference ID: 5145118
OPTION 2 was designed as a Phase 2b multi-center
study to investigate the safety, tolerability and efficacy of
MS1819 (in enteric capsules) in a head-to-head comparison against
the current porcine enzyme replacement therapy (PERT) standard of
care. The primary efficacy endpoint was the coefficient of fat
absorption (CFA), with secondary endpoints of stool weight, signs
and symptoms of malabsorption and coefficient of nitrogen
absorption (CNA). The trial also included an extension arm that
used an immediate release MS1819 capsule, allowing the Company to
compare data from the existing arm that uses enteric (delayed
release) capsules with data from the new arm, and ultimately select
the optimal delivery method.
An audio webcast of the conference call will be
accessible via the Investors section of the AzurRx website
https://azurrx.com/. An archive of the webcast will remain
available for 90 days beginning at approximately 5:30 p.m. ET, on
March 31, 2021.
Phase 2 OPTION 2 Trial
DesignThe Phase 2b OPTION 2 multi-center trial was
designed to investigate the safety, tolerability and efficacy of
MS1819 (2.2 and 4.4 gram doses in enteric capsules) in a
head-to-head comparison versus the current standard of care,
porcine pancreatic enzyme replacement therapy pills. The OPTION 2
trial was an open-label, crossover study, conducted in 15 sites in
the U.S. and Europe. A total of 30 CF patients 18 years or older
were enrolled. MS1819 was administered in enteric capsules to
provide gastric protection and allow optimal delivery of enzyme to
the duodenum. Patients were first randomized into two cohorts: to
either the MS1819 arm, where they received a 2.2 gram daily oral
dose of MS1819 for three weeks; or to the PERT arm, where they
received their pre-study dose of PERT pills for three weeks. After
three weeks, stools were collected for analysis of coefficient of
fat absorption. Patients were then crossed over for another three
weeks of the alternative treatment. After three weeks of cross-over
therapy, stools were again collected for analysis of CFA. A
parallel group of patients were randomized and studied in the same
fashion, using a 4.4 gram daily dose of MS1819. All patients were
followed for an additional two weeks after completing both
crossover treatments for post study safety observation. Patients
were assessed using descriptive methods for efficacy, comparing CFA
between MS1819 and PERT arms, and for safety.
About MS1819MS1819 is a
recombinant lipase enzyme for the treatment of exocrine pancreatic
insufficiency associated with cystic fibrosis and chronic
pancreatitis. MS1819, supplied as an oral non-systemic biologic
capsule, is derived from the Yarrowia lipolytica yeast lipase and
breaks up fat molecules in the digestive tract of EPI patients so
that they can be absorbed as nutrients. Unlike the standard of
care, the MS1819 synthetic lipase does not contain any animal
products.
About Exocrine Pancreatic
InsufficiencyEPI is a condition characterized by
deficiency of the exocrine pancreatic enzymes, resulting in a
patient’s inability to digest food properly, or maldigestion. The
deficiency in this enzyme can be responsible for greasy diarrhea,
fecal urge and weight loss.
There are more than 30,000 patients in the U.S.
with EPI caused by cystic fibrosis according to the Cystic Fibrosis
Foundation and approximately 90,000 patients in the U.S. with EPI
caused by chronic pancreatitis according to the National Pancreas
Foundation. Patients are currently treated with porcine pancreatic
enzyme replacement pills.
About AzurRx BioPharma,
Inc.AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical
stage biopharmaceutical company specializing in the development of
targeted, non-systemic therapies for gastrointestinal (GI)
diseases. The Company has a pipeline of three gut-restricted GI
assets. The lead therapeutic candidate is MS1819, a recombinant
lipase for the treatment of exocrine pancreatic insufficiency (EPI)
in patients with cystic fibrosis and chronic pancreatitis,
currently in two Phase 2 clinical trials. AzurRx is launching two
clinical programs using proprietary formulations of niclosamide, a
pro-inflammatory pathway inhibitor; FW-420, for grade 1 Immune
Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology
patients and FW-1022, for COVID-19 gastrointestinal infections. The
Company is headquartered in Delray Beach, Florida with clinical
operations in Hayward, California. For more information visit
www.azurrx.com.
Forward-Looking StatementThis
press release may contain certain statements relating to future
results which are forward-looking statements. 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, depending
on factors including whether results obtained in preclinical and
nonclinical studies and clinical trials will be indicative of
results obtained in future clinical trials; whether preliminary or
interim results from a clinical trial will be indicative of the
final results of the trial; and the impact of the coronavirus
(COVID-19) pandemic on the Company’s operations and current and
planned clinical trials, including potential delays in clinical
trial recruitment and participation. Additional information
concerning the Company and its business, including a discussion of
factors that could materially affect the Company’s financial
results are contained in the Company’s Annual Report on Form 10-K
for the year ended December 31, 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.1615 South Congress AvenueSuite 103Delray
Beach, Florida 33445Phone: (646) 699-7855info@azurrx.com
Media contact:
Tiberend Strategic Advisors, Inc.Johanna Bennett/Ingrid
Mezo(212) 375-2665/(646)
604-5150jbennett@tiberend.com/imezo@tiberend.com
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