First Wave BioPharma
Announces Dosing of First Patient in Phase 2b Clinical Trial Evaluating
Topical Niclosamide in Patients with Ulcerative Proctitis and Ulcerative
Proctosigmoiditis
Previous Phase 1b clinical data suggest niclosamide delivers favorable
efficacy compared to topical corticosteroid in the treatment of
ulcerative proctitis and ulcerative proctosigmoiditis
BOCA RATON, Fla., Oct. 14, 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 it has dosed the first patient in a Phase 2b
clinical trial investigating a topical formulation of niclosamide
(FW-UP) as a potential treatment for patients with ulcerative proctitis
(UP) and ulcerative proctosigmoiditis (UPS). The trial formally launches
the expansion of the company’s clinical development program for
niclosamide into indications for inflammatory bowel diseases.
UP
and UPS are two types of ulcerative colitis, a chronic inflammatory
bowel disease (IBD) consisting of fine ulcerations in the inner mucosal
lining of the large intestine that do not penetrate the bowel muscle
wall. UPS causes inflammation in the colon and rectum, while UP is
confined only to the rectum.
“With the first
patient now dosed in our Phase 2b clinical trial of FW-UP, we are a step
closer to bringing forth a potentially new therapeutic option for
people suffering from UP and UPS, debilitating GI diseases that often
impact young children and the elderly and for which there is no cure,”
stated James Sapirstein, President and CEO of First Wave BioPharma.
“Following our recent acquisition of First Wave Bio, our development
program for niclosamide has expanded to multiple ulcerative colitis
indications, which represent a significant and growing patient
population. In the U.S. last year, it is estimated that there were more
than 825,000 ulcerative colitis diagnoses, with the market for
ulcerative colitis, UP and UPS estimated at approximately $5 billion
annually. These are just a few of the IBD indications where we believe
our proprietary formulations of niclosamide could provide potentially
attractive treatment options given that they have a known safety
profile, are non-systemic, and could reduce or eliminate entirely the
need of steroids and immunomodulators.”
The
Phase 2b trial is a placebo-controlled study that will enroll up to 28
patients to compare FW-UP, administered as an enema twice daily at a
dose of 450 mg, to placebo enemas twice daily. Patient screening is
underway at clinical trial sites in Italy and will start soon in Austria
and Germany. First Wave BioPharma is also planning a separate clinical
trial to investigate an oral formulation of niclosamide as a potential
treatment for pancolitis.
The Phase 2b trial
builds on preliminary data from a previous Phase 1b trial evaluating a
low-dose (150 mg/twice daily) and a Phase 2a high-dose (450 mg/twice
daily) of FW-UP in patients with UP and UPS. Data from the first 17
patients treated in the low-dose cohort demonstrated niclosamide to be
well tolerated, with a durable therapeutic effect and a clinical
remission rate of 59%. Although these initial trial results are based
upon early stage data, this rate of remission compares favorably to the
rates of 38% to 44% reported for the commonly used steroid, budesonide.
In data collected from the first four patients in the high-dose cohort,
niclosamide was also shown to be well tolerated.
Giovanni
Monteleone, M.D., primary investigator for the trial and a
gastroenterologist at the University of Rome Tor Vergata, stated, “Small
molecule drugs, and in particular niclosamide, represent one of the
most interesting potential advances in the treatment of IBDs.
Niclosamide can be administered without the use of needles and can be
formulated to target the area of GI tract where disease-causing
inflammation occurs. Moreover, niclosamide offers the potential to avoid
the systemic complications sometimes caused by steroids and other
immunosuppressants. The data from the previous clinical trial provided
the first proof of principle for niclosamide as a treatment for IBD, and
now with this new Phase 2b trial underway, we hope to determine whether
patients will achieve better results from higher doses of the drug.”
About Niclosamide Niclosamide
is a prescription small molecule drug known for its anti-inflammatory
and anti-viral properties. 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.
About FW-UP FW-UP
is a niclosamide-based, small molecule anti-inflammatory inhibitor
therapy for the treatment of ulcerative proctitis (UP) and ulcerative
proctosigmoiditis (UPS). A Phase 1b/2a clinical trial evaluated the
safety and potential efficacy of a topical rectal formulation of FW-UP
in patients with UP and UPS, and First Wave BioPharma has advanced the
compound into a Phase 2b trial.
About Ulcerative Proctitis and Ulcerative Proctosigmoiditis Ulcerative
proctitis and ulcerative proctosigmoiditis are two types of ulcerative
colitis, a chronic inflammatory bowel disease (IBD) consisting of fine
ulcerations in the inner mucosal lining of the large intestine that do
not penetrate the bowel muscle wall. UPS causes inflammation in the
colon and rectum, while UP is confined only to the rectum. Symptoms
include weight loss, fatigue, abdominal pain and cramps, rectal pain and
bleeding, and diarrhea, although constipation can also develop as the
body struggles to maintain normal bowel function. UP and UPS can occur
at any point throughout life, with a high occurrence in young children
and then again around 40-50 years of age. Progression of this disease to
ulcerative colitis, extending farther up the bowel to involve the
sigmoid colon, occurs in about 30-50% of patients. Although there is a
range of treatments to help ease symptoms and induce remission, there is
no cure.
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.
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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