Entero Therapeutics’ Chairman and CEO James Sapirstein Provides Business Update with Focus on Latiglutenase Development Program
31 Juli 2024 - 1:00PM
Entero Therapeutics, Inc., (NASDAQ: ENTO), (“Entero Therapeutics”
or the “Company”), a clinical-stage biopharmaceutical company
specializing in the development of targeted, non-systemic therapies
for gastrointestinal (GI) diseases, today released a letter
from James Sapirstein, the Company’s Chairman and CEO, to provide
stockholders with a business update.
LETTER FROM OUR CHAIRMAN AND CHIEF
EXECUTIVE OFFICER
To my fellow stockholders,
We are making substantial progress in the
development and on the regulatory pathways with our lead product
candidate, latiglutenase, a late-stage clinical asset for the
treatment of celiac disease. Our primary focus is on advancing
latiglutenase into a pivotal Phase 3 trial in 2025. Our recent
regulatory agency interactions and operational changes outlined
below reflect our sharp focus on positioning Entero for success
with this lead program that can potentially address the unmet
treatment needs for the millions of people currently struggling
with celiac disease.
After reviewing previous results from the Phase
2b clinical trial of latiglutenase, we decided to submit two Type D
meeting requests to the FDA to build a more precise and efficient
Phase 3 clinical trial design and development plan for
latiglutenase.
The first meeting request seeks approval to
change the number of proposed cohorts in the latiglutenase Phase 3
trial from three (600 mg, 1200 mg and placebo) to two (1200 mg and
placebo). Since the safety of 1200 mg of latiglutenase has been
shown to be comparable to lower doses in previous Phase 2 trials,
we believe the higher dose will maximize the efficacy of
latiglutenase and provide us with the greatest potential to achieve
success in the primary endpoint and key secondary endpoints. This
adjustment should reduce the number of patients required for a
Phase 3 trial and has the potential to both lower its estimated
cost and shorten the time to an interim data read-out and trial
completion by several months.
We also plan to submit a second Type D meeting
request in the next few weeks to finalize our histology-related
secondary efficacy endpoints based on previous FDA communications
and recent Phase 2 study results demonstrating statistically
significant histologic improvements relative to placebo using the
highest doses of latiglutenase.
Additionally, we are preparing a response to the
most recent end of Phase 2 and Type C meeting correspondence with
the FDA to propose an updated protocol and streamlined trial design
with the single-dose regimen and a focus on the most severe and
symptomatic patient population demonstrating intestinal damage.
These modifications are designed to expedite and maximize the
potential success of the Phase 3 clinical trial.
Despite the challenging market conditions
affecting all clinical-stage biopharma companies, we completed a
small financing that generated $1.9 million in gross proceeds to
help support our movement toward initiation of the Phase 3 trial.
We have also consolidated our bi-coastal operations into one office
at our Boca Raton headquarters. This move streamlines processes,
reduces overhead costs and creates a more cohesive work
environment, enabling our team to work more efficiently and
effectively toward our goals.
We thank our stockholders for their continued
support and confidence. By focusing our resources and efforts on
our most promising program, we are in the strongest position for
near-term success, which will serve as a foundation for the
advancement of latiglutenase.
Sincerely,
James SapirsteinChairman and CEOEntero
Therapeutics, Inc.
About Entero Therapeutics,
Inc.Entero Therapeutics 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 with multiple late-stage clinical programs
built around three proprietary technologies: latiglutenase, a Phase
3-ready, potentially first-in-class, targeted, oral biotherapeutic
for celiac disease; capeserod, a selective 5-HT4 receptor partial
agonist being developed for gastroparesis; and adrulipase, a
recombinant lipase enzyme designed to enable the digestion of fats
and other nutrients in cystic fibrosis and chronic pancreatitis
patients with exocrine pancreatic insufficiency. Entero
Therapeutics is headquartered in Boca Raton, Florida. For more
information visit www.enterothera.com.
Forward-Looking StatementsThis
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 Company’s current and future capital
requirements and its ability to raise additional funds to satisfy
its capital needs, whether any financing or licensing transaction
may be obtained, completed in an untimely manner, or not at all;
whether the Company will be able to realize the expected benefits
of its acquisition of ImmunogenX; the Company’s ability to
integrate the assets and contemplated commercial operations
acquired from ImmunogenX into the Company’s business; 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; whether the Company will be able to maintain compliance with
Nasdaq’s continued listing criteria and the effect of a delisting
from Nasdaq on the market for the Company’s securities; the size of
the potential markets for the Company’s drug candidates and its
ability to service those markets; and the effects of the First Wave
Bio, Inc. acquisition, the related settlement and their effect on
the Company’s business, operating results and financial prospects.
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, 2023, 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:Entero Therapeutics,
Inc.777 Yamato Road, Suite 502Boca Raton, FL 33431Phone: (561)
589-7020info@enterothera.com
Media contact:
Russo PartnersDavid Schull or Liz Phillips(347)
956-7697david.schull@russopartnersllc.comelizabeth.phillips@russopartnersllc.com
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