Entero Therapeutics Announces Peer-Reviewed Publication Unveiling Novel Algorithm for Measuring Intestinal Damage in Celiac Disease
27 Juni 2024 - 12:00PM
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 announced the
publication of “A Composite Morphometric Duodenal Biopsy Mucosal
Scale for Celiac Disease Encompassing Both Morphology and
Inflammation” in Clinical Gastroenterology and Hepatology, a
pre-eminent journal of the American Gastroenterological Association
(AGA) that publishes innovative diagnostic and therapeutic advances
in clinical gastroenterology.
As the number of promising therapies for celiac
disease (CeD) grows, so does the need to improve the measurement of
clinically relevant histological endpoints. The new approach
presented in a peer-reviewed publication, led by Jack Syage, Ph.D.,
President and Chief Scientific Officer of Entero Therapeutics,
recognized the need to advance beyond qualitative measures of
histologic small intestinal health and to develop a more accurate
and sensitive scale based on the independent quantitative measures
of architectural changes (villus height to crypt depth ratio,
Vh:Cd) and inflammation (intraepithelial lymphocyte count, IEL)
already in use. The team created a composite score (VCIEL) for
these two measures that helps overcome the individual variances to
improve the overall accuracy of histological evaluation. The
publication demonstrated the significant benefits of the VCIEL
scale based on the results of four previous clinical trials. The
significance of this achievement was highlighted in a special
editorial feature by the journal, demonstrating the importance of
this novel metric to CeD researchers.
“VCIEL can provide a higher predictive value to
evaluate the efficacy of adjunct therapies in development,” stated
Markku Mӓki, M.D., Ph.D., Faculty of Medicine and Health Technology
at Tampere University and co-author of the publication. “We believe
that using VCIEL will result in a more accurate histological
assessment for CeD patients and greater sensitivity in measuring
therapeutic benefit. With this approach, we anticipate an enhanced
ability to address unmet need in the Celiac
community.”
“We believe the development of VCIEL represents
a significant step forward in the management of Celiac Disease and
offers new possibilities for improving patient care and treatment
outcomes,” stated Dr. Syage. “Moving forward, we anticipate further
validation of VCIEL through future clinical trials, including our
Phase 3 latiglutenase study, with the aim of establishing a new
gold standard for measuring clinically meaningful responsiveness to
treatment.”
About
Latiglutenase Latiglutenase, an oral biotherapeutic
comprising two gluten-specific recombinant enzymes, is being
developed to treat celiac disease in conjunction with a gluten-free
diet. It has demonstrated efficacy in alleviating GI symptoms of
celiac disease and preventing or improving intestinal damage in
Phase 2 trials. The Phase 3 clinical program for latiglutenase is
being discussed with the GI Division of the U.S. Food and Drug
Administration (FDA), and the initiation of the Phase 3 trials is
expected in early 2025.
About Celiac
Disease Celiac disease (CeD) is a chronic, autoimmune
disease in which eating gluten (a protein found in wheat, rye, and
barley) causes damage to the lining of the small intestine, leading
to malabsorption. CeD can present with highly variable
gastrointestinal and extra-intestinal clinical manifestations,
including anemia, chronic migraine, peripheral neuropathy,
cognitive impairment, vitamin B-12 deficiency, unexplained
infertility, and others that impact activities of daily living and
increased healthcare costs. Currently, the only treatment for CeD
is life-long adherence to a strict gluten-free diet. About
one-third of patients on a gluten-free diet persist with symptoms
or malabsorption signs. The seroprevalence of Celiac disease in
adults is approximately 1.4% of the worldwide population.
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 its proprietary technologies, including:
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 whether
any financing or licensing transaction may be completed, completed
with different terms, 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; 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; 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, 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 info@enterothera.com
Media contact: Russo Partners David Schull
or Liz Phillips (347) 956-7697
david.schull@russopartnersllc.com elizabeth.phillips@russopartnersllc.com
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