Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a
leader in the development of orally delivered peptides and
therapeutic proteins, presented 2 posters at the Annual Society of
Bone and Mineral Research (ASBMR) 2023 Annual Meeting held on
October 13-16, 2023 in Vancouver, BC, Canada. Both posters will be
available on the Company’s website, www.enterabio.com.
“Entera’s ability to consistently deliver our
oral PTH(1-34) peptide in a simple mini tablet format with
reproduceable, dose dependent pharmacokinetics and rapid biological
responses irrespective of gender, age, and health status is
testament to the robustness of our oral peptide platform. This work
also builds the foundation for our oral PTH(1-34) tablets to
potentially treat diverse patient populations including younger men
and women athletes at risk of stress fractures,” said Miranda
Toledano, Chief Executive Officer of Entera.
The lead drug candidate of Entera’s EBP05
formulation, EB613 is currently being developed as the first
once-daily oral anabolic therapy for the treatment of osteoporosis.
In a 6-month, 161-patient, placebo-controlled Phase 2 study, EB613
produced rapid dose-proportional changes in biochemical markers and
increased Bone Mineral Density (BMD) in postmenopausal women with
low BMD osteoporosis.
Abstract Title: First Oral
PTH(1-34) Tablet Treatment for Osteoporosis Demonstrates Rapid
Pharmacodynamic Effect on Plasma Levels of Endogenous
PTH(1-84)
A Phase 1 study comparing oral EB613,
subcutaneous (SC) hPTH(1-34) 20 g (Forteo®) and a new generation of
Entera’s oral peptide delivery platform is ongoing. One of the
first objectives of this study is to rapidly evaluate the
pharmacodynamic (PD) effects of Entera’s oral PTH(1-34) tablets.
This analysis relates to Entera’s lead formulation. Additional data
on new formulations will be released later in 2023.
An increase in plasma ionized calcium should
result in decreased secretion and plasma concentrations of
endogenous PTH(1-84). Thus, a reduction in plasma PTH(1-84) should
provide an early indication of the systemic exposure and
pharmacologic activity of Entera’s oral PTH(1-34) tablets. In the
study, the mean percentage of endogenous plasma PTH (1-84) 120
minutes after dosing was 59.2%, 54.3%, and 52.3% for EB613 1.5 mg,
2.5 mg and Forteo®, respectively; and showed consistent effects
across other early PD markers such as serum calcium, phosphorus,
and 1,25-dihydroxyvitamin D.
“EB613 oral tablets (1.5 mg and 2.5 mg doses)
rapidly decreased plasma concentrations of PTH(1-84) in all
subjects, in a dose proportional manner. The results provide early
proof of the systemic exposure and pharmacological activity to
Entera’s orally administered PTH(1-34) tablets. The ability to
rapidly evaluate PD effects as early markers of therapeutic
response is crucial to assessing a drug’s activity in osteoporosis
patients and potentially optimize their management. In contrast,
response with conventional PD markers of bone metabolism may take
several months. Thus, we plan to continue to measure PTH(1-84)
responses in further clinical development of EB613,” said Art
Santora, MD, Entera’s Chief Medical Officer.
Abstract Title:
Pharmacokinetic (PK) Profile of EBP05/EB613 Oral
Teriparatide Tablets in Women of Post Menopausal Age Versus Young
Adult Men.
This retrospective analysis compares the
pharmacokinetic profile of EBP05 in healthy young males versus
female patients of menopausal age with hypoparathyroidism.
A single administration of the same dose, 2.25
mg oral PTH (1-34), in healthy young men (22 years, range 21-26)
and women of postmenopausal age (62 years, range 49 -63) resulted
in a median Cmax of 425 pg/ml vs 521 pg/ml, and a median AUC of 157
pg*hour/ml vs 158 pg*hour/ml respectively.
“The data showed a consistent PK profile following
administration of oral EBP05 tablets in both young men and women of
menopausal age. These similar profiles indicate that similar doses
of our oral PTH tablets may be used across these different
populations,” said Gregory Burshtein PhD, Entera’s Head of Research
and Development.
About Entera Bio
Entera focuses on significant unmet medical
needs where an oral form of a peptide treatment or protein
replacement therapy holds the potential to transform the standard
of care. The Company’s oral PTH*(1-34) teriparatide mini tablets
have been administered to a total of 240 subjects (153 patients)
across Phase 1 and Phase 2 studies, with demonstrated
bioavailability and clinical benefit across two distinct diseases.
The Company’s most advanced product candidate, EB613 (oral
synthetic hPTH (1-34)), is being developed as the first oral,
osteoanabolic (bone building) once-daily tablet treatment for
post-menopausal women with low BMD and high-risk osteoporosis, with
no prior fracture. A placebo controlled, dose ranging Phase 2 study
of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker)
and secondary endpoints (BMD). Entera is preparing to initiate a
Phase 3 registrational study for EB613. EB612 is being developed as
the first tablet peptide replacement therapy for the treatment of
hypoparathyroidism. The Company is currently conducting a phase 1
PK study of novel PTH formulations using its proprietary, next
generation oral delivery platform with data expected in the second
half of 2023. Entera is also developing oral GLP-2 program as an
injection-free alternative for patients suffering from short bowel
syndrome and other severe intestinal and malabsorption metabolic
conditions and oral Oxyntomodulin (GLP1/glucacon) for obesity in
collaboration with OPKO Health. 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
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