Full Press Release Details
Entero Therapeutics' Chairman and CEO
James Sapirstein Provides Business Update with Focus on Latiglutenase Development Program
BOCA RATON, Fla., July 31, 2024 (GLOBE NEWSWIRE)
- 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
To my fellow stockholders,
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.
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.
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.
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.
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.
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.
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.
Entero 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 Statements
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 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 502
Boca Raton, FL 33431
Phone: (561) 589-7020
David Schull or Liz Phillips