Full Press Release Details
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
Agreement expands AzurRx's pipeline of targeted, non-systemic
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
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
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
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).
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
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.
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
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
Wainwright & Co. is acting as financial advisor to AzurRx in
connection with the licensing transaction.
About Immune Checkpoint Inhibitor-Associated Colitis and
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
44% of patients with advanced and metastatic cancer tumors
(~260,000 patients) are eligible to receive immune checkpoint
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%
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
About COVID-19 Gastrointestinal Infections
Gastrointestinal infection symptoms (severe diarrhea, vomiting and
abdominal pain) have been reported in ~18% of COVID-19