Entera Bio to Present Two Abstracts on its First-in-Class, Once Daily Oral hPTH(1-34) Peptide Tablets (EB613) for the Treatment of Post-Menopausal Women at High Risk of Fracture at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting
August 16 2023 - 8:30AM
Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a
leader in the development of orally delivered peptides and
therapeutic proteins, today announced that it has been selected to
present data for its investigational agent EB613 at the ASBMR 2023
Annual Meeting on October 13-16, 2023 in Vancouver, BC, Canada.
EB613 [hPTH(1-34) tablets] is being developed as the first
once-daily oral anabolic (bone forming) mini tablet therapy for
post-menopausal women with high risk osteoporosis. It is estimated
that 54 million adults, representing 50 percent of the U.S. adult
population over age 50, are at risk of a fragility fracture and
approximately 1 in 5 older adults will die within the year
following a hip fracture. Due to a lower peak bone density as
compared to men and decreases in estradiol after menopause, women
are affected in greater numbers. Post menopausal osteoporosis
afflicts more women globally than cancer and cardiovascular disease
and is a serious health concern. “Available treatments, while
efficacious, fail to provide a viable solution for patients that no
longer respond to antiresorptive medications and are unwilling to
take an injectable anabolic drug or cumbersome device. As
potentially, the first once daily hPTH(1-34) peptide tablet
therapy, our EB613 program is dedicated to address the vast
treatment gap in current osteoporosis care,” said Miranda Toledano,
Chief Executive Officer at Entera.
Abstract Title: Pharmacokinetic (PK)
Profile of EBP05/EB613 Oral Teriparatide Tablets in Women of Post
Menopausal Age Versus Young Adult MenPresentation
Number: SAT-456Presentation
Type: Poster
PresentationSession: Poster Session I
Session Date/Time: Saturday, October 14,
2023, 1:30 pm – 3:00 pm
Abstract Title: First Oral hPTH(1-34)
Tablet Treatment for Osteoporosis Demonstrates Rapid
Pharmacodynamic Effect on Plasma Levels of Endogenous
PTH(1-84)Presentation Number: LB
SUN-646Presentation Type: Late Breaking
Poster PresentationSession: Late-Breaking
Poster Session ISession Date/Time: Sunday,
October 15, 2023, 1:30 pm – 3:00 pm Presentation
Time: 1:30 pm – 3:00 pm
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. EB613 is the first oral, once daily mini tablet
presentation of synthetic hPTH (1-34), consisting of the same 34
amino acid sequence as daily subcutaneous teriparatide injection,
Forteo®. 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. Entera is currently preparing to initiate a
Phase 3 registrational study for EB613. A phase 1 PK study of novel
PTH formulations was initiated in H1 2023 to ascertain feasibility
of a new hypo candidate (a prior formulation had positive Phase 2a
data announced in 2015 and published in the JBMR in 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 may be contractually
obligated to provide; 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.
Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com
Entera Bio (NASDAQ:ENTX)
Historical Stock Chart
From Apr 2024 to May 2024
Entera Bio (NASDAQ:ENTX)
Historical Stock Chart
From May 2023 to May 2024