Blueprint
Exhibit 99.1
AzurRx BioPharma CEO Issues Letter to Shareholders
NEW YORK, NY, October 22, 2019 – AzurRx BioPharma, Inc.
(“AzurRx” or the “Company”) (NASDAQ: AZRX),
a company specializing in the development of non-systemic,
recombinant therapies for gastrointestinal diseases,
today issued the following letter to its shareholders and the
investment community from its newly appointed CEO, James
Sapirstein.
Dear
AzurRx Shareholders,
It is
with great pleasure that I am writing to you as the new President
and Chief Executive Officer of AzurRx BioPharma, Inc.
I am
very excited to join the AzurRx team as we advance MS1819 and our
product pipeline towards their next milestones. I joined AzurRx
because I firmly believe in the clinical and commercial potential
of MS1819 and see that there is a clear path to the market.
Additionally, I was drawn by the support of the seasoned management
and world-class clinical teams.
By way
of background, I have over 35 years of pharmaceutical industry
experience spanning areas such as drug development and
commercialization. I have been the CEO of three biotechnology
companies (ContraVir, Alliqua Therapeutics, and Tobira
Therapeutics) and over the course of my career have participated in
23 product launches as a senior executive at such companies as
Gilead, Bristol-Myers Squibb and Roche.
In the
past week, AzurRx has made two major positive announcements. Early
last week we announced that the first patients were dosed in our
Phase 2 combination therapy study for cystic fibrosis (CF) patients
with severe exocrine insufficiency. This has significance for the
one-third of CF patients whose nutritional needs cannot be met with
porcine enzymes alone. Our second announcement was that the Cystic
Fibrosis Foundation Data Safety Monitoring Board (DSMB), which
reviewed our Phase 2 OPTION study results, concluded that MS1819 is
safe and supported our plan to proceed to a higher 4-gram dose of
MS1819 in the next Phase 2 replacement therapy clinical trial. The
DSMB’s support will bolster our investigational new drug
(IND) application with the FDA and enable us to continue working
with Cystic Fibrosis Foundation-supported clinical sites and
investigators.
Looking
forward, we are on track to meet with the FDA in December and to
initiate the Phase 2 4-gram study in Q1 2020. Based on our
experience with the OPTION study, we anticipate rapid enrollment,
completion, and topline data read-out before the end of 2020. In
addition, we anticipate an initial read-out from the combination
therapy study by mid-year 2020.
I would
like to ensure our investors that the entire management team and I
are focused on building shareholder value and on executing upon our
milestones. We firmly believe in the potential for MS1819 and are
committed to moving forward in development, including ensuring that
we have the capital to execute on our plans.
I look
forward to meeting with you and to speaking with you about our
progress.
Best
regards, James
James
Sapirstein
President
& CEO
AzurRx
BioPharma, Inc.
About MS1819-SD
MS1819-SD, supplied as an oral non-systemic biologic capsule, is a
recombinant enzyme that is derived from
the yarrowia
lipolytica lipase, and
unlike PERTS, which are the current standard of care, does not
contain any animal products.
About Exocrine Pancreatic Insufficiency:
EPI is a condition characterized by deficiency of the
exocrine pancreatic enzymes, resulting in the inability
to digest food properly, or maldigestion. This deficiency can be
responsible for greasy diarrhea, fecal urge and weight
loss.
The digestive standard of care for both CF and chronic pancreatitis
(CP) patients with EPI are commercially-available PERTs. Ideally, a
stable daily dose of PERT will enable CF patients to eat a normal
to high-fat diet and minimize unpleasant gastrointestinal symptoms.
In practice, however, a substantial number of CF patients (~30%) do
not achieve normal absorption of fat with PERTs(1,2).
Achieving an optimal nutritional status, including normal fat
absorption levels, in CF patients is important for maintaining
better pulmonary function, physical performance and prolonging
survival. Furthermore, a decline of body mass index around the age
of 18 years predicts a substantial drop in lung
function(3,4).
In many cases, patients with severe EPI cannot use higher doses of
commercially-available PERTs to alleviate these issues because they
are on doses that are at or near the maximum dose recommended by
the CFF guidelines. The concern for higher doses is the risk
of fibrosing colonopathy.
There are approximately 90,000 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.
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-SD recombinant lipase for
EPI 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 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-SD and final results of the Phase 2
combination study described in this press release or any of the
Company’s other clinical development activities, are
contained in the Company’s Annual Report on Form 10-K for the
year ended December 31, 2018 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 304
Brooklyn, NY 11226
Phone: (646)-699-7855
info@azurrx.com
Investor Relations contact:
LifeSci Advisors, LLC.
Hans Vitzthum, Managing Director
250 West 55th Street - Suite 16B
New York, NY 10019
Phone: 617-535-7743
www.lifesciadvisors.com
hans@lifesciadvisors.com
References
(1) Freedman, S.D., Am. J. Manag.
Care, 2017; 23:
S2220-S228
(2) Littlewood, J. et al, 2006, Pediatric
Pulmonology, 2006,
41:35-49
(3) Engelen, M. et al, 2014, Curr. Opin. Clin. Nutr. Metab.
Care;
17(6):515-520
(4) Vandenbranden, S.L. et al, 2012, Pediatric
Pulmonology, 2012; 47(2):
135-143