Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a
leader in the development of orally delivered peptides and
therapeutic proteins, reports today that the American Society for
Bone and Mineral Research (ASBMR) has announced that the SABRE
(Strategy to Advance BMD as a Regulatory Endpoint) project team has
submitted to the U.S. Food and Drug Administration (FDA) its full
qualification plan to use the treatment-related change in bone
mineral density (BMD) as a surrogate endpoint for fractures in
future trials of new anti-osteoporosis drugs.
BMD is the first surrogate endpoint undergoing
qualification by the FDA under the 21st Century Cures Act which was
signed into law on December 13, 2016, to help accelerate medical
product development and bring new innovations and advances to
patients who need them faster and more efficiently.
“This submission is critical to the future of
osteoporosis drug innovation which has been hampered by ethical and
cost constraints associated with fracture outcome studies. We would
like to sincerely acknowledge and thank the ASBMR-FNIH-SABRE team
for its significant contributions and for furthering this key
initiative with the FDA,” said Miranda Toledano, Chief Executive
Officer of Entera. “The last 15 months have been intense for Entera
from a regulatory standpoint, and we believe EB613 stands as the
first program to potentially avail itself of the ASBMR-SABRE BMD
endpoint. We have powered our proposed phase 3 study using the
published SABRE quantitative thresholds which statistically
correlate to reductions in vertebral, non-vertebral and all site
fracture risk. Much like biomarkers and validated surrogates that
are routinely used across oncology, cardiovascular and metabolic
disorders, we look forward to FDA’s potential qualification of BMD
for osteoporosis and to promptly advancing EB613 forward using this
more ethical approach,” said Ms. Toledano.
EB613 (oral PTH (1-34), teriparatide), is being
developed as the first oral, osteoanabolic (bone building)
once-daily tablet treatment for osteoporosis. In a phase 2,
6-month, 161-patient, placebo-controlled study EB613 produced rapid
dose-proportional increases in biochemical markers of bone
formation, reductions in markers of bone resorption, and increased
lumbar spine, total hip, and femoral neck BMD in postmenopausal
women with low mass or osteoporosis and no prior fracture. In
October 2022, following a Type C meeting, Entera announced FDA’s
concurrence that a 2-year, placebo-controlled phase 3
(registrational) study with Total Hip BMD as primary endpoint could
support an NDA for EB613.
About ASBMR-FNIH
SABREi
Initiated in 2013, the Foundation for the
National Institutes of Health (FNIH) Biomarkers Consortium Bone
Quality Project assembled data from more than 150,000 participants
across more than 50 clinical trials of anti-osteoporosis drugs. The
project team re-evaluated these existing data to understand which
measurements could predict the ability of the treatment to reduce
fractures. The study findings identified an increase in bone
mineral density, as measured by a low-dose X-ray imaging technique,
as a strong predictor of the extent to which treatments reduce
fracture risk. A change in bone mineral density could therefore be
used in future clinical trials to determine the effectiveness of
osteoporosis drugs. Through a partnership with ASBMR, the FNIH
extended and continues to support the original study, renamed
SABRE, to seek FDA approval for the surrogate biomarker.
About the Cures Act
The 21st Century Cures Act (Cures Act), signed
into law on December 13, 2016, is designed to help accelerate
medical product development and bring new innovations and advances
to patients who need them faster and more efficiently.
The law builds on FDA's ongoing work to
incorporate the perspectives of patients into the development of
drugs, biological products, and devices in FDA's decision-making
process. Cures enhances our ability to modernize clinical trial
designs, including the use of real-world evidence, and
clinical outcome assessments, which will speed the development and
review of novel medical products, including medical
countermeasures.
It also provides new authority to help FDA
improve our ability to recruit and retain scientific, technical,
and professional experts and it establishes new expedited product
development programs.
About Entera Bio
Entera focuses on significant unmet medical
needs where an oral tablet 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 PTH
(1-34), teriparatide), 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 peptide as an
injection-free alternative for patients suffering from short bowel
syndrome and other severe intestinal and malabsorption metabolic
conditions and oral Oxyntomodulin (GLP1/glucagon) peptide 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.
______________________________i
https://www.asbmr.org/about/news-release-detail/asbmr-sabre-team-submits-full-qualification-plan-t
Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com
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