First Wave BioPharma Announces FDA Clearance of IND Application for Phase 2a PASSPORT Trial of FW-IC
Tuesday, October 19, 2021
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First Wave BioPharma
Announces FDA Clearance of IND Application for Phase 2a PASSPORT Trial
of FW-ICI-AC as Treatment for Immune Checkpoint Inhibitor-Associated
ColitisBOCA RATON, Fla., Oct. 19, 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, announced today that the U.S. Food
and Drug Administration (FDA) has reviewed the Investigational New Drug
(IND) application and provided a “Study May Proceed” letter for the
Company’s Phase 2a PASSPORT trial investigating FW-ICI-AC as a treatment
for Grade 1 and Grade 2 colitis and diarrhea in oncology patients
receiving treatment with immune checkpoint inhibitors (ICIs). FW-ICI-AC
is a proprietary oral immediate-release tablet formulation of
niclosamide, a prescription small molecule with anti-inflammatory and
anti-viral properties.
The Phase 2a PASSPORT
clinical trial is designed as a double-blind, placebo-controlled study
to determine the safety, tolerability, and preliminary efficacy of
FW-ICI-AC in the treatment of immune checkpoint inhibitor-associated
colitis (ICI-AC) and diarrhea in advanced cancer patients. 60 patients
will be enrolled in the trial and divided into two arms (30 patients per
arm). One arm will receive FW-ICI-AC three times daily for two weeks,
while the other arm will receive placebo three times daily for two
weeks. Following treatment, each patient will enter a four-week
evaluation period. The primary endpoint of the trial is safety and
tolerability of FW-ICI-AC. Additional endpoints will measure early
signals of efficacy, including resolution of the patient’s diarrhea,
sparing of steroids, and prevention of disease progression. “We
are very pleased to have received IND clearance to initiate the
PASSPORT clinical trial investigating FW-ICI-AC as a potential treatment
for immune-checkpoint associated colitis and diarrhea. Importantly, the
approved IND protocol includes an amended trial protocol that is
expected to enable accelerated patient enrollment and a more efficient
time to trial completion,” stated James Sapirstein, President and CEO of
First Wave BioPharma. “As many as 30 percent of cancer patients treated
with checkpoint inhibitors develop diarrhea that can progress to
colitis, a condition that can be debilitating and, at times,
life-threatening due to the compromised health of the patient and the
impact if patients are forced to halt their cancer treatment. We believe
our proprietary formulation of niclosamide has the potential to be the
first drug specifically for early-stage Grade 1 and Grade 2 ICI-AC.” First
Wave BioPharma’s proprietary formulation of niclosamide is also the
subject of a Phase 2 clinical trial (RESERVOIR) as a potential treatment
for COVID-19-related gastrointestinal (GI) infections and a Phase 2b
clinical trial in patients with ulcerative proctitis (UP) and ulcerative
proctosigmoiditis (UPS), two forms of ulcerative colitis – an
inflammatory bowel disease (IBD). James
Pennington, M.D., Chief Medical Officer of First Wave BioPharma,
commented, “The revised clinical trial protocol should allow us to
accelerate patient enrollment and also shorten the time it takes to
complete the trial and report data. This is one of several clinical
programs we are advancing to explore the potential of niclosamide in the
gastrointestinal space, and we look forward to a number of milestones
in the coming months.” About FW-ICI-AC
FW-ICI-AC
is a niclosamide-based, small molecule, anti-inflammatory inhibitor
therapy for the treatment of immune checkpoint inhibitor-associated
colitis (ICI-AC) and diarrhea in advanced cancer patients. FW-ICI-AC
(formerly FW-420) will be supplied to the PASSPORT clinical trial as a
proprietary oral immediate-release tablet formulation. The standard care
for treating inflammatory bowel diseases (IBD) such as ulcerative
colitis and Crohn’s disease, corticosteroids and other immunosuppressive
agents can cause problems when used for check point inhibitor patients
due to their immunosuppressant effects. FW-ICI-AC has the potential to
safely treat Grade 1 and Grade 2 ICI-associated colitis and diarrhea and
prevent its progression to more serious and potentially fatal later
stages. The overall goal of early niclosamide treatment is to enable
oncology patients to remain on, or spend minimal time off, their ICI
treatment programs without interruption. 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. About the PASSPORT Study
The
Phase 2a PASSPORT clinical trial is designed as a double-blind,
placebo-controlled study to determine the safety, tolerability, and
preliminary efficacy of FW-ICI-AC in the treatment of immune checkpoint
inhibitor-associated colitis (ICI-AC) and diarrhea in advanced cancer
patients. 60 patients will be enrolled in the trial and divided into two
arms (30 patients per arm). One arm will receive FW-ICI-AC three times
daily for two weeks, while the other arm will receive placebo three
times daily for two weeks. Following treatment, each patient will enter a
four-week evaluation period. The primary endpoint of the trial is
safety and tolerability of FW-ICI-AC. Additional endpoints will measure
early signals of efficacy, including resolution of the patient’s
diarrhea, sparing of steroids, and prevention of disease progression. About Immune Checkpoint Inhibitor-Associated Colitis
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. The global
market for ICIs was over $22 billion in 2019 and growing rapidly.1
However, many immune-related adverse events, especially diarrhea and
colitis, limit their use. The incidence of ICI-AC with diarrhea ranges
from 1% to 30% depending on the type of ICI and whether they are used in
combination.2 The onset of diarrhea in ICI-AC patients
occurs within 6-7 weeks after starting treatment and progressively
worsens, and the progression to colitis is rapid and unpredictable. For
example, in patients taking ipilimumab (Yervoy), between 25% and 30% of
patients developed diarrhea and roughly 8% to 12% developed colitis
proven by endoscopy.3 Moreover, the 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-systemic therapeutic, such as niclosamide, for Grade 1 or 2 colitis
with diarrhea may prevent progression to even more severe Grades of
colitis. There currently is no approved treatment for Grade 1 colitis. About First Wave BioPharma, Inc.
First
Wave BioPharma, Inc. is a clinical-stage biopharmaceutical company
specializing in the development of targeted, non-systemic therapies for
gastrointestinal (GI) diseases. First Wave BioPharma 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. First Wave BioPharma’s niclosamide portfolio is led by three
clinical programs: FW-COV, for COVID-19 gastrointestinal infections;
FW-UP, for ulcerative proctitis (UP) and ulcerative proctosigmoiditis;
and FW-ICI-AC, for Grade 1 and Grade 2 Immune Checkpoint
Inhibitor-associated colitis and diarrhea in advanced oncology patients.
Two additional formulations of niclosamide, FW-UC (ulcerative colitis)
and FW-CD (Crohn’s disease) are expected to enter the clinic in 2022 and
2023, respectively. First Wave BioPharma 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 with clinical operations
in Hayward, California. 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] Media contact:
Tiberend Strategic Advisors, Inc.
David Schemelia / Ingrid Mezo
(609) 468-9325 / (646) 604-5150
[email protected] / [email protected] References:
1 Immune Checkpoint Inhibitors Market, ResearchAndMarkets.com, 2020.
2
Wang et al. Patients with ICPI-induced diarrhea or colitis have
improved survival outcomes. J Immunother Cancer. 2018; 6: 37. Som et
al., World J Clin Cases. Feb 26, 2019; 7(4): 405-418
3
Wang DY, Ye F, Zhao S, et al. Incidence of immune checkpoint
inhibitor-related colitis in solid tumor patients: a systematic review
and meta-analysis. Oncoimmunology 2017; 10: e1344805; Som et al., World J
Clin Cases. Feb 26, 2019; 7(4): 405-418
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