AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX),
a company specializing in the development of targeted, non-systemic
therapies for gastrointestinal (GI) diseases, today announced
that it has completed enrollment of the initial cohort into Part 1
of its 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 for the treatment of COVID-19-related GI
infections.
Once all patients in this cohort complete their
full two weeks of treatment, the trial’s Data Monitoring Committee
(DMC) will review the safety data. Successful DMC review will then
trigger enrollment into Part 2 of the trial, focused on
demonstrating efficacy and extending safety observations.
James Sapirstein, President and CEO of AzurRx,
stated, “Completion of enrollment in the first part of our Phase 2
RESERVOIR clinical trial is an important step in our plan to
develop niclosamide as a potential treatment for COVID-19 related
GI infection. Despite the availability of vaccines, COVID-19
continues to infect people at an alarming rate due to the emergence
of more contagious variants. Ultimately, it is our belief that
therapeutic solutions will be needed to truly put an end to this
pandemic. We believe that niclosamide could play an important role
on this front and we look forward to reporting topline results from
the RESERVOIR trial in the first quarter of 2022.”
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 (SARS2), the virus
that causes COVID-19, from the GI tract. The primary efficacy
measure of the RESERVOIR trial is the rate of fecal SARS2 clearance
(stool sample) assessed by 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.
James Pennington, M.D., Chief Medical Officer of
AzurRx, commented, “Physicians continue to report that the GI
infections caused by COVID-19 remain an underappreciated aspect of
the disease, even though these symptoms impact almost 20 percent of
COVID-19 patients. We believe our micronized oral niclosamide
therapy has the potential to target the SARS2 virus directly in the
gastrointestinal tract, where research suggests the virus often
hides, replicates and causes illness long after the initial
infection.”
About Phase 2 RESERVOIR Clinical
TrialThe Phase 2 RESERVOIR clinical trial is a two-part,
two-arm, placebo-controlled study examining the safety and efficacy
of niclosamide in patients with COVID-19 Gastrointestinal
Infection.
The two primary objectives of this trial are to
confirm the safety of niclosamide in treatment of patients with
COVID-19 GI infection, and to demonstrate efficacy in clearing the
SARS-CoV-2 (SARS2) virus from the GI tract. Part 1 of the trial
will study 9 to 18 patients with COVID-19 and GI positive stools
for SARS2. Patients will be treated for 14 days and observed
closely for any signs of safety issues. A Data Monitoring Committee
will then review the safety profile and if niclosamide is
well-tolerated, the trial will move on to Part 2.
Part 2 will be conducted in outpatients with
COVID-19 and PCR positive stools for SARS2. Patients will be
randomized to either niclosamide 400 mg tablets, three times a day,
or to placebo tablets, three times a day. After 14 days of
treatment, patients will be taken off study drugs and remain on
study observation for up to 6 weeks. The efficacy endpoint is
analyzed by time to clearance from stools of SARS2, comparing the
niclosamide arm to the placebo arm. Long term observation will also
be important to indicate whether niclosamide treatment might
improve ‘long haul’ COVID-19 symptoms.
Additional information about the RESERVOIR trial
can be found at www.covidgi.com and on ClinicalTrials.gov.
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, 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 SARS-CoV-2 virus as ACE-2, the entry receptor for
COVID-19, is highly expressed on GI cells. There currently is no
targeted treatment for COVID-19 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-19 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-19. Importantly, the manufacturing
process for niclosamide can be scaled up to supply large
populations quickly.
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
small molecule with anti-viral and anti-inflammatory properties:
FW-1022, for COVID-19 gastrointestinal infections and FW-420, for
Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis
and diarrhea in advanced oncology patients. The Company is
headquartered in Boca Raton, Florida with clinical operations in
Hayward, California. For more information
visit www.azurrx.com.
Forward-Looking StatementThis
press release may contain certain statements relating to future
results which are forward-looking statements. 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 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 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 Road, Suite 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:1Gut 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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