AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX),
a company specializing in the development of targeted non-systemic,
recombinant therapies for gastrointestinal (GI) diseases,
today announced the completion of site initiation visits and the
addition of five (5) new clinical trial sites in Ukraine for the
ongoing RESERVOIR Phase 2 clinical trial evaluating FW-1022 as a
treatment for COVID-19-related gastrointestinal (GI) infections.
FW-1022 is a proprietary oral tablet formulation of micronized
niclosamide developed for the treatment of COVID-19-related GI
infections.
The RESERVOIR clinical trial is designed as a two-part, two-arm,
placebo-controlled Phase 2 study. The trial’s primary objectives
are to confirm the safety of FW-1022 in the treatment of patients
with COVID-19-related GI infections and to evaluate its efficacy in
clearing SARS-CoV-2 from the GI tract. The primary efficacy measure
of the RESERVOIR trial is the rate of fecal SARS-CoV-2 clearance
(stool sample) assessed by RT-PCR, comparing the niclosamide arm to
the placebo arm for up to six weeks. These long-term observation
data could indicate that niclosamide treatment has the potential to
improve “long haul” COVID-19 symptoms. Topline data from the study
is anticipated during the first quarter of 2022.
“Niclosamide represents an important advance in the fight to
help COVID-19 patients overcome the debilitating and often
overlooked effect the virus can have on the GI system,” said James
Sapirstein, Chairman, CEO and President of AzurRx BioPharma. “While
vaccines have been delivered to millions of people, COVID-19, and,
in particular, the highly infectious Delta variant, remains a
significant concern, especially in regions of the U.S. and areas of
the world where vaccination rates are low. The addition of new
trial sites in Ukraine provides enhanced opportunity to enroll
patients in a country where less than 5% of the population is fully
vaccinated for COVID-19.”
“FW-1022 is an orally delivered, non-systemic formulation of
niclosamide that is designed to deliver high concentrations of the
drug directly to the GI tract,” said Dr. James Pennington, Chief
Medical Officer of AzurRx BioPharma. “We believe these properties
have the potential to decrease viral load and GI-associated
symptoms of COVID and look forward to accelerating the progress of
the RESERVOIR trial to, hopefully, introduce the first therapeutic
specifically designed to treat COVID GI infections.”
Additional information about the RESERVOIR trial can be found at
the www.covidgi.com website and on ClinicalTrials.gov.
The RESERVOIR trial is being managed by PPD, Inc., a leading
global contract research organization (CRO). AzurRx is also
developing a proprietary formulation of micronized niclosamide
(FW-420) as a treatment for immune checkpoint inhibitor-associated
colitis.
About COVID-19 Gastrointestinal
InfectionsGastrointestinal infection symptoms (severe
diarrhea, vomiting and abdominal pain) have been reported in
approximately 18% of COVID-19 cases.1 Of the 33 million individuals
who are reported to have contracted COVID-19 in the U.S.,2 this
would translate into 6 million patients having GI infection. Of the
165 million cases globally,3 it would translate into almost 30
million patients. Furthermore, approximately 10% of patients who
were infected with COVID have persistent symptoms months after
their initial diagnosis.3 Approximately 86% of these COVID “long
haulers” are reported to have GI infection symptoms, with 60%
continuing to have diarrhea months after their initial
infection.4
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. There currently is no targeted treatment for
COVID GI infections.
About NiclosamideNiclosamide is a prescription
small molecule drug listed as an essential medicine by the World
Health Organization (WHO). Niclosamide has been safely used on
millions of patients for other clinical indications. In the U.S.,
niclosamide was approved by the U.S. Food and Drug Administration
(FDA) in 1982 for the treatment of intestinal tapeworm infections.
In addition to its antihelminthic activity, niclosamide has
demonstrated anti-inflammatory and anti-viral properties.
There remains an urgent need to develop new medicines that can
be manufactured at large scale quickly to treat COVID-19.
Niclosamide was recently identified by the Institut Pasteur Korea
as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19,
with potency 40X greater than remdesivir.5 Additionally, emerging
evidence confirms the severe GI-related complications of COVID and
potential fecal spread of the virus. The Company’s clinical trials
may establish that patients treated with an oral and non-systemic
niclosamide formulation that delivers high local GI concentrations
have decreased viral load and GI-associated symptoms of COVID.
Importantly, the manufacturing process for niclosamide can be
scaled up to supply large populations quickly.
FW-1022FW-1022 is a niclosamide based small
molecule which the Company’s clinical trials may establish has
anti-viral activity that is effective for the treatment of
SARS-CoV-2 (COVID-19) gastrointestinal infections. FW-1022 is
anticipated to be supplied as an oral immediate release tablet. The
formulation to be used has been milled (micronized) to allow
superior dissolution in the gut fluids. This in turn may allow
local niclosamide concentrations to reach anti-viral levels. Thus,
FW-1022 has the potential to benefit COVID patients by decreasing
viral load in the GI tract, treating infection symptoms and
preventing transmission of the virus through fecal spread.
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
two gut-restricted GI assets in three clinical indications. 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. AzurRx is also
advancing two clinical programs using proprietary formulations of
niclosamide, a pro-inflammatory pathway inhibitor: FW-1022, for
COVID-19 gastrointestinal infections and FW-420, for grades 1 and 2
Immune Checkpoint Inhibitor-associated colitis and diarrhea in
oncology patients. The Company is headquartered in Boca Raton,
Florida with clinical operations in Hayward, California. For more
information visit http://www.azurrx.com/.
Forward-Looking StatementThis 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. These
forward-looking statements are subject to risks and uncertainties
including, among other things, the completion of the public
offering, the satisfaction of customary closing conditions related
to the public offering and the intended use of proceeds from the
public offering. 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 risks
and uncertainties related to market conditions; 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; the size of the
potential markets for the Company’s drug candidates and its ability
to service those markets; and the Company’s current and future
capital requirements and its ability to raise additional funds to
satisfy its capital needs. 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, 2020 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.777
Yamato RoadSuite 502Boca Raton, FL 33431Phone: (561)
589-7020info@azurrx.com
Media contact:Tiberend Strategic Advisors,
Inc.Johanna Bennett / David Schemelia(212) 375-2665 / (609)
468-9325jbennett@tiberend.com / dschemelia@tiberend.com
References:
1 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: 20202 New York Times. (7/1/21)
https://www.nytimes.com/interactive/2020/world/coronavirus-maps.html3
Rubin, R. “As their numbers grow, COVID-19 “Long Haulers” Stump
Experts”. https://jamanetwork.com/journals/jama/fullarticle/2771111
September 23, 2020. 4 Davis, et al. “Characterizing
Long Covid in an International Cohort: 7 Months of
Symptoms and their
Impact”. https://www.medrxiv.org/content/10.1101/2020.12.24.20248802v2.full.pdf5
Jeon S, Ko M, Lee J, Choi I, Byun SY, Park S, Shum D, Kim S. 2020.
Identification of antiviral drug candidates against SARS-CoV-2 from
FDA-approved drugs. Antimicrob Agents Chemother
64:e00819-20. https://doi.org/10.1128/AAC.00819-20.
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