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8-K - CURRENT REPORT - AzurRx BioPharma, Inc. | azrx8k_nov172020.htm |
Exhibit 99.1
AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2
Study of MS1819 in Cystic Fibrosis Patients
Potential to add additional study arm utilizing immediate release
capsules
Trial objectives, endpoints and statistical analysis to remain the
same
DELRAY BEACH, Florida, Nov. 17, 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 that it will be
submitting a protocol amendment request to the U.S. Food and Drug
Administration (FDA) for its Phase 2b OPTION 2 trial of MS1819 for
the treatment of exocrine pancreatic insufficiency in patients with
cystic fibrosis. The proposed amendment will add a study arm
that uses 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.
“We are pleased to announce that our OPTION 2 trial is well
ahead of schedule and almost fully enrolled without any safety
issues being observed,” said Dr. James Pennington, Chief
Medical Officer of AzurRx. “As this trial progresses, we
believe there may be significant clinical value in adding a study
arm that uses our immediate release capsules. Our intention is to
identify the optimal delivery method and potentially provide
additional scientific support and optionality for
MS1819.”
Dr. Pennington added, “The key objectives of any Phase 2
program are to test for safety and efficacy, but another important
goal is to determine appropriate doses and drug delivery method
prior to entering the Phase 3 portion of the clinical program. If
the amendment is accepted by the FDA, we anticipate enrollment into
the new study arm to begin in December 2020.”
James Sapirstein, CEO of AzurRx commented, “The protocol
amendment represents an opportunity to gain valuable additional
clinical data with no significant increase in overall trial costs
or delays to our timeline projections. We remain on target to
release top line data in the first quarter of 2021, as has been our
guidance to date.”
About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical
company specialized in the research and development of
non-systemic biologics for gastrointestinal disorders. The
Company is focused on the development of its lead
drug candidate, MS1819. AzurRx is currently conducting two
Phase 2 clinical trials of MS1819: the OPTION 2
monotherapy trial, and the Combination therapy
trial, consisting of MS1819 in conjunction with
porcine-derived pancreatic enzyme replacement therapy, the
current standard of care. The Company is headquartered in Delray
Beach, Florida with clinical operations in Hayward, California.
Additional information on the Company can be found
at www.azurrx.com.
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, 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 such as the interim results presented will be
indicative of the final results of the trial. 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, the results of its clinical trials,
and the impact of the coronavirus (COVID-19) pandemic on the
Company’s operations and current and planned clinical trials,
including, but not limited to delays in clinical trial recruitment
and participation 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.
760 Parkside Avenue, Suite 327F
Brooklyn, NY 11226
Phone: (646)-699-7855
info@azurrx.com
Investor Relations contact:
LifeSci Advisors, LLC.
Hans Vitzthum, Managing Director
1 International Place, Suite 1480
Boston, MA 02110
Phone: 617-430-7578
hans@lifesciadvisors.com