Attached files
Exhibit
99.1
AzurRx BioPharma Announces Exclusive
Worldwide License Agreement with First Wave Bio for Use of
Proprietary Niclosamide Formulations to Treat Immune Checkpoint
Inhibitor-Associated Colitis and COVID-19 Gastrointestinal
Infections
●
Agreement expands AzurRx’s pipeline of targeted, non-systemic
GI therapies
●
Clinical trials to initiate in 1H’21, with potential for
expedited FDA 505(b)(2) pathway for IND-approved COVID-19 and
breakthrough designation for immune checkpoint colitis
programs
●
Management to
discuss the agreement with First Wave Bio and the company’s
two new clinical programs on a call scheduled for
today, Monday, January 4, 2021, at 8:30 a.m. Eastern
Time
Delray Beach, FL – January 4, 2020 (GLOBE NEWSWIRE) --
AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the
“Company”), a company specializing in
the development of non-systemic therapies
for gastrointestinal (GI) diseases, today announced
that it has signed an exclusive worldwide licensing agreement with
First Wave Bio, Inc. (“First Wave”) for the use of
their patented and proprietary oral and rectal formulations of
niclosamide for the treatment of immune checkpoint
inhibitor-associated colitis (ICI-AC) and COVID-19 GI
infections.
Niclosamide
is a small molecule drug that was approved by the FDA in 1982 for
the treatment of intestinal tapeworm infections and is on the World
Health Organization’s (WHO) list of essential medicines. It
has been safely used by millions of patients and is being
investigated as a potential new therapy for inflammatory diseases
and viral infections. Founded in 2015, First Wave has invested in
translational biology along with process development and
manufacturing to develop proprietary oral and rectal gut-targeted
formulations of niclosamide for the treatment of ICI-AC, COVID-19
GI-infections, and inflammatory bowel disease (IBD).
“The
acquisition of rights to niclosamide for these indications gives us
an opportunity to strategically expand our existing pipeline and
pursue multiple GI indications in the oncology and infectious
disease arenas," said James Sapirstein, President and Chief
Executive Officer of AzurRx. “We are impressed with First
Wave’s Phase 1b/2a clinical data, strong IP and patent
position, and the significant unmet medical needs and market
opportunities addressed by these two assets. We believe these
niclosamide formulations could offer significant advantages over
other currently available treatments. They are not systemically
absorbed, potentially allowing for higher local GI concentrations
of drug delivery and avoiding steroid-related immunosuppressant
complications.”
Mr.
Sapirstein continued, “With these new assets, combined with
our current pipeline, we believe 2021 will be a very exciting and
transformational year for AzurRx. AzurRx is on track to report
top-line data for its two Phase 2 MS1819 clinical trials in the
first and second quarters of 2021 and anticipates initiating both
the Phase 2 COVID-19 GI Infection trial and a Phase 1b/2a ICI-AC
trial in the first half of 2021.”
Gary D.
Glick, Ph.D., Co-Founder and Chief Executive Officer of First Wave
Bio, added “The license of our niclosamide technology for the
immune checkpoint inhibitor and COVID indications is a significant
milestone for our company and we are very pleased to have found a
clinical and commercial development partner in AzurRx. We look
forward to working with the AzurRx team to take our novel
niclosamide therapies to the clinic in 2021 and to rapidly bringing
these therapies to cancer and COVID-19
patients.”
Under
the terms of the agreement, AzurRx is granted a worldwide,
exclusive right to develop, manufacture, and commercialize First
Wave’s proprietary immediate release oral and enema
formulations of niclosamide for the treatment of ICI-AC and
COVID-19 GI infections. First Wave will receive an upfront payment
of $10.25 million in cash payable $9.0 million at closing and $1.25
million by June 30, 2021 and $3.0 million of Convertible Junior
Preferred Stock, which shall be convertible into common stock
following shareholder approval, and up to $74.0 million in
potential development and commercial milestones, as well as mid
single-digit royalties on product sales for the ICI-AC and COVID-19
GI indications.
H.C.
Wainwright & Co. is acting as financial advisor to AzurRx in
connection with the licensing transaction.
About Immune Checkpoint Inhibitor-Associated Colitis and
Diarrhea
Immune checkpoint inhibitors (ICIs) are monoclonal antibodies that
target down-regulators of the anti-cancer immune response and have
revolutionized the treatment of a variety of malignancies. However,
many immune-related adverse events, especially diarrhea and
colitis, limit their use. The incidence of immune-mediated colitis
(IMC) ranges from 1%-25% depending on the type of ICI and whether
they are used in combination used in
combination.1
Approximately
44% of patients with advanced and metastatic cancer tumors
(~260,000 patients) are eligible to receive immune checkpoint
inhibitors (ICIs).2
Approximately
30% of ICI patients develop diarrhea, which can progress to
colitis. The onset of diarrhea in ICI-AC patients occurs within 6-7
weeks and progressively worsens, and the progression to colitis is
rapid and unpredictable. For example, in patients taking ipilimumab
(Yervoy), between 25-30% of patients developed diarrhea and ~8-12%
developed colitis.2
Moreover, the
trend is towards the use of combination ICI therapies (e.g. Yervoy
and Opdivo) and this will lead to a concomitant increase in both
diarrhea and colitis.
Administration of corticosteroids, or treatment with certain
immunosuppressive biologics, while withholding ICI therapy are
recommended for grade 2 or more severe colitis (National Cancer
Institute 2020). The impact of this colitis complication and
treatment may reduce the goal of progression free cancer survival.
An oral, non-absorbed treatment, such as niclosamide, for grade 1
colitis (diarrhea) may prevent progression to grade 2 disease.
There currently is no approved treatment for grade 1
colitis.
About COVID-19 Gastrointestinal Infections
Gastrointestinal infection symptoms (severe diarrhea, vomiting and
abdominal pain) have been reported in ~18% of COVID-19
cases4.
Of the 19 million individuals who are reported to have contracted
COVID-19 in the United States, this would translate into 3.4
million patients having GI infection. Of the 81 million cases
globally, it would be 15 million.
There is some evidence to support the view that the GI tract is a
possible reservoir for recurrence and fecal spread of the COVID-19
virus as ACE-2, the entry receptor for COVID-19, is highly
expressed on GI cells.4
There currently
is no targeted treatment for COVID GI
infections.
Conference Call and Webcast Information
The management team will host a conference call today, Monday,
January 4, 2021 at 8:30 am Eastern Time to discuss the license
agreement with First Wave and the company’s two new clinical
programs that are launching in 2021. To participate in the call,
dial 877-407-0784 (domestic) or 201-689-8560 (international)
fifteen minutes before the conference call begins and reference the
conference passcode 13714501.
The live conference call can be accessed via audio webcast
at http://public.viavid.com/index.php?id=142841
A replay of the call will be available on
the “Investor
Relations”section of the
Company’s website (www.azurrx.com).
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.
About First Wave Bio, Inc.
First Wave Bio was founded to improve the lives of people living
with IBD. Recent discoveries in immune cell metabolism have opened
up the possibility of selectively targeting disease-causing immune
cells to treat inflammatory diseases without unwanted side effects
such as broad immunosuppression. First Wave has developed a suite
of MetaWave product candidates, gut-restricted small molecules that
target the metabolism of disease-causing Th17 cells. The
company’s first clinical MetaWave program, FW-424, has shown
benefits for patients with mild-to-moderate ulcerative colitis in a
Phase 1b/2a trial. First Wave is advancing FW-424 through
additional clinical studies in patients with mild-to-moderate IBD.
Given FW-424’s novel mechanisms of action and established
safety profile, First Wave believes that it has the potential to
replace current standard-of-care and improve the lives of patients
at all stages of IBD. For more information,
visit www.firstwavebio.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 its clinical assets, 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.
1615 South Congress Avenue
Suite 103
Delray
Beach, Florida 33445
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
1 Wang et al. Patients with ICPI-induced diarrhea or colitis have
improved survival outcomes.
J Immunother Cancer.
2018; 6: 37. Som et al.,
World J Clin Cases. Feb
26, 2019; 7(4): 405-418
2 Wang DY, Ye F, Zhao S, et al. Incidence of immune
checkpoint inhibitor-related colitis in solid tumor patients: a
systematic review and meta-analysis. Oncoimmunology 2017; 10:
e1344805; Som et al.,
World J Clin Cases. Feb
26, 2019; 7(4): 405-418
3 Wang et al. Patients with ICPI-induced diarrhea or colitis have
improved survival outcomes.
J Immunother Cancer.
2018; 6: 37.
4 Gut
Journal:
Vol 69, Issue 6: 2020; Gut
Journal:
Vol 69, Issue 6: 2020; JAMA
Network:
Vol 3, Issue 6: 2020; Lancet
Gastroenterol Hepatol: Vol 5, Issue 5: 2020;
Cheung Gastroenterology: Vol. 159, Issue 1:
2020.