Entera’s Oral Delivery of GLP-2 Pre-Clinical Data to be Published in Peer Reviewed, International Journal of Peptide Research and Therapeutics
03 5월 2023 - 10:34PM
Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”) a leader
in the development of orally delivered peptides and therapeutic
proteins, today announced that its pre-clinical manuscript entitled
“Oral Delivery Technology Enabling Gastro-Mucosal Absorption of
Glucagon-Like-Peptide-2 Analog (GLP-2), Teduglutide - A Novel
Approach for Injection-Free Treatment of Short Bowel Syndrome” has
been accepted for publication by the International Journal of
Peptide Research and Therapeutics.
Short bowel syndrome (SBS) is a rare and
potentially life-threatening malabsorptive condition caused by a
significant loss of functional bowel mass (secondary to congenital
defects or disease-associated loss of absorption) or physical bowel
mass (secondary to extensive intestinal resection). SBS patients
have a reduced ability to absorb nutrients and fluids and are at
risk of malnutrition, unintended weight loss and additional
symptoms due to the loss of essential vitamins and minerals1. SBS
is the most common cause of chronic intestinal
failure, accounting for approximately 75% of cases of chronic
intestinal failure in adults and 50% such events in children.2
Teduglutide, a GLP-2 analog and mainstay treatment for SBS, is
known to enhance intestinal absorption. Teduglutide treatment
requires daily sub-cutaneous injections.
“There are several new generation GLP-2 analogs
under development which may also require chronic injections. As
part of our R&D initiatives, Entera is leveraging on its
proprietary platform to enable a potential first-in-class oral
GLP-2, daily tablet treatment for patients with short bowel
syndrome (SBS) and other disorders requiring parenteral nutrition.
We are looking forward to sharing our in vivo findings with the
community in the coming weeks,” said Miranda Toledano, Chief
Executive Officer of Entera.
About Entera Bio
Entera is a leader in the development of orally
delivered macromolecules, including peptides and other therapeutic
proteins. The Company focuses on significant unmet medical needs
where a daily mini tablet form of a peptide treatment or
replacement therapy holds the potential to transform the standard
of care. The Company’s most advanced product candidates, EB613 for
the treatment of high risk, post-menopausal osteoporosis and EB612
for the treatment of hypoparathyroidism, are in clinical
development. Both EB612 and EB613 are being developed to address
undertreated diseases which disproportionately afflict women. EB613
is the first oral, once daily mini tablet presentation of synthetic
hPTH (1-34), (teriparatide), consisting of the exact same 34 amino
acid sequence as daily subcutaneous teriparatide injection,
Forteo®, a mainstay anabolic treatment which requires daily SC
injections. A placebo controlled, dose ranging Phase 2 study of
EB613 tablets (n= 161) met primary (PD/biomarker) and secondary
endpoints (BMD) in a dose dependent manner and was presented at the
ASBMR 2021 Annual Conference. A phase 1 PK study of novel PTH
formulations is planned for H1 2023 to ascertain feasibility of a
new hypo candidate (a prior formulation had positive Phase 2a data
announced in 2015 and published in JBMR 2019) and for another
potential indication. For more information on Entera Bio, visit
www.enterabio.com.
Cautionary Statement Regarding Forward
Looking Statements
Various statements in this press release are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements (other
than statements of historical facts) in this press release
regarding our prospects, plans, financial position, business
strategy and expected financial and operational results may
constitute forward-looking statements. Words such as, but not
limited to, “anticipate,” “believe,” “can,” “could,” “expect,”
“estimate,” “design,” “goal,” “intend,” “may,” “might,”
“objective,” “plan,” “predict,” “project,” “target,” “likely,”
“should,” “will,” and “would,” or the negative of these terms and
similar expressions or words, identify forward-looking statements.
Forward-looking statements are based upon current expectations that
involve risks, changes in circumstances, assumptions and
uncertainties. Forward-looking statements should not be read as a
guarantee of future performance or results and may not be accurate
indications of when such performance or results will be
achieved.
Important factors that could cause actual
results to differ materially from those reflected in Entera’s
forward-looking statements include, among others: changes in the
interpretation of clinical data; results of our clinical trials;
the FDA’s interpretation and review of our results from and
analysis of our clinical trials; unexpected changes in our ongoing
and planned preclinical development and clinical trials, the timing
of and our ability to make regulatory filings and obtain and
maintain regulatory approvals for our product candidates; the
potential disruption and delay of manufacturing supply chains; loss
of available workforce resources, either by Entera or its
collaboration and laboratory partners; impacts to research and
development or clinical activities that Entera is contractually
obligated to provide, such as those pursuant to Entera’s agreement
with Amgen; overall regulatory timelines; the size and growth of
the potential markets for our product candidates; the scope,
progress and costs of developing Entera’s product candidates;
Entera’s reliance on third parties to conduct its clinical trials;
Entera’s expectations regarding licensing, business transactions
and strategic collaborations; Entera’s operation as a development
stage company with limited operating history; Entera’s ability to
continue as a going concern absent access to sources of liquidity;
Entera’s ability to obtain and maintain regulatory approval for any
of its product candidates; Entera’s ability to comply with Nasdaq’s
minimum listing standards and other matters related to compliance
with the requirements of being a public company in the United
States; Entera’s intellectual property position and its ability to
protect its intellectual property; and other factors that are
described in the “Cautionary Statements Regarding Forward-Looking
Statements,” “Risk Factors” and “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” sections
of Entera’s most recent Annual Report on Form 10-K filed with the
SEC, as well as the company’s subsequently filed Quarterly Reports
on Form 10-Q and Current Reports on Form 8-K. There can be no
assurance that the actual results or developments anticipated by
Entera will be realized or, even if substantially realized, that
they will have the expected consequences to, or effects on, Entera.
Therefore, no assurance can be given that the outcomes stated or
implied in such forward-looking statements and estimates will be
achieved. Entera cautions investors not to rely on the
forward-looking statements Entera makes in this press release. The
information in this press release is provided only as of the date
of this press release, and Entera undertakes no obligation to
update or revise publicly any forward-looking statements, whether
as a result of new information, future events or otherwise, except
to the extent required by law.
___________________________1
https://rarediseases.org/rare-diseases/short-bowel-syndrome/2 Zhu
C, Li Y. An updated overview of glucagon-like peptide-2 analog
trophic therapy for short bowel syndrome in adults. J Int Med Res.
2022 Mar;50(3):3000605221086145. doi: 10.1177/03000605221086145.
PMID: 35343263; PMCID: PMC8966062.
Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com
Entera Bio (NASDAQ:ENTX)
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