First Wave BioPharma
Announces Independent Data Monitoring Committee Provides Positive
Interim Safety Assessment for Part 2 COVID-19 RESERVOIR Clinical Trial
of Niclosamide for the Treatment of Gastrointestinal Infections
Review of Data from Initial 25 Patients Completed with Favorable Recommendation
BOCA RATON, Fla., Nov. 30, 2021 (GLOBE NEWSWIRE) --
First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or
the “Company”), a clinical-stage biopharmaceutical company specializing
in the development of targeted, non-systemic therapies
for gastrointestinal (GI) diseases, today announced that an independent
data monitoring committee (DMC) has recommended that enrollment continue
in Part 2 of the ongoing RESERVOIR Phase 2 trial evaluating FW-COV as a
treatment for COVID-19-related gastrointestinal (GI) infections. FW-COV
is a proprietary, oral, tablet formulation of micronized niclosamide
developed to remove SARS-CoV-2 (SARS2), the virus that causes COVID-19,
from the GI tract.
The DMC recommendation
was based on its review of the safety data collected from the first 25
patients enrolled in Part 2 of the RESERVOIR trial. The review of the
data uncovered no safety issues. Part 2 of the study will enroll up to
150 patients.
James Sapirstein, President and
CEO of First Wave BioPharma, stated, “The DMC’s review of interim safety
data was very positive with no substantive safety issues documented in
the initial 25 patients dosed in Part 2 of the RESERVOIR trial. This
news comes at a critical time in the COVID-19 pandemic with the rise of
the fast-spreading Omicron variant, declared last week by the World
Health Organization as a variant of concern. Because niclosamide targets
the entire virus, and not just the spike protein, we believe that
FW-COV may prove effective against multiple strains of COVID-19 and may
provide an effective therapeutic to help millions of COVID-19 patients
overcome the debilitating and often overlooked effect the virus can have
on the GI system. Based on current timelines and pacing of enrollment,
which is strong, we expect to report topline results from the RESERVOIR
trial next year, including an assessment of FW-COV’s ability to clear
the COVID-19 virus from the GI tract.”
RESERVOIR
is designed as a two-part, two-arm, randomized, placebo-controlled
Phase 2 study with a primary purpose to confirm the safety of FW-COV and
assess the drug’s ability to remove the SARS-CoV-2 (SARS2) virus from
the digestive tract. Patients enrolled in Part 2 of the study are
randomized to receive either niclosamide or a placebo treatment for 14
days. After 14 days, patients will cease treatment but remain under
observation for up to six weeks, with additional follow-up observations
at 4 month and 6-months to assess persistence or recurrence of symptoms.
The efficacy of FW-COV is measured by the rate of SARS2 clearance from
stool samples assessed by PCR test, comparing the niclosamide arm and
the placebo arm. Long-term observation could indicate whether
niclosamide treatment has the potential to prevent “long haul” COVID-19
symptoms.
James Pennington, M.D., Chief Medical
Officer of First Wave BioPharma, commented, “Despite vaccination
campaigns and booster shots, COVID-19 and its growing family of
dangerous variants continue to spread, and the virus’ lingering effects
have developed into a major medical issue for millions of people.
Research suggests SARS2 may form reservoirs in the GI tract and cause
illness long after the abatement of the initial infection. Early data
demonstrated that our micronized oral niclosamide therapy is well
tolerated, and we believe that FW-COV may have the ability to remove
these viral reservoirs from the GI tract, adding a much needed drug to
the COVID treatment regimen.”
Gastrointestinal
infection symptoms (severe diarrhea, vomiting and abdominal pain) have
been reported in approximately 18% of COVID-19 cases1 and it is estimated that approximately 43% of all COVID patients may have the virus present in their GI tracts.2 Of the 48 million individuals who are reported to have contracted COVID-19 in the U.S.,3 this
would translate into over 8 million patients having GI infection with
symptoms. Of the 260 million cases reported globally,4 it
would translate into almost 47 million patients with GI infection
symptoms. Furthermore, approximately 10% of patients who were infected
with COVID have persistent symptoms months after their initial
diagnosis.4 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.5 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.6 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-COV FW-COV
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-COV 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 First Wave BioPharma, Inc. The
Company is a clinical-stage biopharmaceutical company specializing in
the development of targeted, non-systemic therapies for gastrointestinal
(GI) diseases. The Company is currently advancing a therapeutic
development pipeline populated with multiple clinical stage programs
built around its two proprietary technologies – niclosamide, an oral
small molecule with anti-viral and anti-inflammatory properties, and the
biologic adrulipase, a recombinant lipase enzyme designed to enable the
digestion of fats and other nutrients. The Company’s niclosamide
portfolio is led by two clinical programs in Phase 2 clinical trials:
FW-COV, for COVID-19 gastrointestinal infections and FW-UP, for
ulcerative proctitis (UP) and ulcerative proctosigmoiditis. Three
additional indications of niclosamide, FW-ICI-AC, for Grade 1 and Grade 2
Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced
oncology patients, FW-UC (ulcerative colitis) and FW-CD (Crohn’s
disease) are expected to enter the clinic in 2022 and 2023. The Company
is also advancing FW-EPI (adrulipase) for the treatment of exocrine
pancreatic insufficiency (EPI) in patients with cystic fibrosis and
chronic pancreatitis. The Company is headquartered in Boca Raton,
Florida. For more information visit www.firstwavebio.com.
Forward-Looking Statement This
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; the effects of the First Wave Bio, Inc. acquisition and
its announcement on the Company’s business, operating results and
financial prospects; the integration of the First Wave Bio, Inc.
business with the Company’s own business; 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: First Wave BioPharma, Inc. 777 Yamato Road, Suite 502 Boca Raton, FL 33431 Phone: (561) 589-7020 [email protected]
References: 1 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. 2 Wong, M, et.
al. “Detection of SARS-CoV-2 RNA in fecal specimens of patients with
confirmed COVID-19: A meta-analysis”. Journal of Infection 81 (2020)
e31-e38; Doorn, A. “Systematic review with meta-analysis: SARS-CoV-2
stool testing and the potential for faecal-oral transmission.”
Alimentary Pharmacology & Therapeutics. 2020: 52:1276-1288. 3 New York Times. (11/26/21) https://www.nytimes.com/interactive/2021/world/coronavirus-maps.html 4 Rubin,
R. “As their numbers grow, COVID-19 “Long Haulers” Stump Experts”.
https://jamanetwork.com/journals/jama/fullarticle/2771111 September 23,
2020. 5 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.pdf 6 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.
BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in the BioPharma, MedTech, Digital Health and Health Systems that collectively employ nearly 107,000 Floridians. Source: TEConomy/BIO (released 2022)
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