AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”),
a clinical stage biopharmaceutical company specializing in the
development of targeted, non-systemic therapies
for gastrointestinal (GI) diseases, announced today the
administration of the first dose of FW-1022 to a volunteer in the
ongoing Phase 2 RESERVOIR clinical trial. FW-1022 is a proprietary
oral tablet formulation of micronized niclosamide developed for the
treatment of COVID-19-related GI infections. Topline results from
the trial are expected in the first quarter of 2022.
“Dosing the first patient in the RESERVOIR
clinical trial marks a significant milestone for AzurRx and the
development of niclosamide as a potential treatment for
COVID-19-related GI infections,” said James Sapirstein, Chief
Executive Officer of AzurRx BioPharma. “There are currently no
approved treatments available for COVID-19-related GI infections.
If our development program is successful, we believe that FW-1022
could help prevent reinfection and the spread of COVID-19, as well
as treat certain potentially severe complications that many people
believe to be caused by the ability of SARS-CoV-2 to hide in
reservoirs within the GI tract. We believe our micronized oral
niclosamide therapy has the potential to target the virus directly
in the gut and play an important role in treating COVID-19 patients
experiencing the damaging aftereffects of COVID-19-related GI
infection.”
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 (rectal swab or stool sample) assessed
by RT-PCR, comparing the niclosamide arm to the placebo arm for up
to six months. These long-term observation data could indicate that
niclosamide treatment has the potential to improve “long haul”
COVID-19 symptoms.
“As a practicing clinician, I have treated
hundreds of COVID-19 patients with many reporting GI issues
resulting from the virus, including severe diarrhea, vomiting and
abdominal pain. However, COVID-related GI infection remains an
underappreciated and often untreated aspect of the disease despite
its prevalence and adverse impact on the patient,” said Salma
Saiger, M.D., of SMS Clinical Research, LLC and an investigator
with the RESERVOIR clinical trial. “Given this, there is a pressing
need to develop therapeutics to directly treat SARS-CoV-2 that may
be hiding in the GI tract. Preclinical evidence suggests that
micronized niclosamide could provide such an opportunity, and I am
excited to be part of the investigative team researching the drug
in the Phase 2 RESERVOIR trial.”
“Evidence continues to build in support of
niclosamide as a potential COVID-19 therapy, including research
from the Institut Pasteur Korea suggesting that niclosamide could
be 40 times more potent than remdesivir in inhibiting SARS-CoV-2,”
said James Pennington, M.D., Chief Medical Officer of AzurRx. “We
believe FW-1022, our micronized formulation of niclosamide, is
ideally equipped to clear SARS-CoV-2 hiding in the gut due to its
proven safety profile and known effectiveness in treating other GI
ailments, and its ability to remain in the gut for long periods of
time. We look forward to reporting topline data from RESERVOIR in
early 2022.”
More information about this clinical trial is
available at ClinicalTrials.gov.
About COVID-19 Gastrointestinal
Infections
Gastrointestinal 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 Niclosamide
Niclosamide 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-1022
FW-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 three gut-restricted GI
assets. 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,
currently in two Phase 2 clinical trials. AzurRx is launching two
clinical programs using proprietary formulations of niclosamide, a
pro-inflammatory pathway inhibitor: FW-1022 for COVID-19
gastrointestinal infections, and FW-420 for grade 1 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 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 the ability of the Company to finance its
operations; 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; and the impact of the coronavirus (COVID-19) pandemic on
the Company’s operations, including potential delays in clinical
trial recruitment and participation. 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 RoadSuite 502Boca Raton,
Florida 33431Phone: (561) 589-7020info@azurrx.com
Media contact:
Tiberend Strategic Advisors, Inc.Johanna Bennett/Ingrid
Mezo(212) 375-2665/(646)
604-5150jbennett@tiberend.com/imezo@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.
(5/20/21)
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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