Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a
leader in the development of orally delivered peptides, announced
today that The American Society for Bone and Mineral Research
(ASBMR) announced on March 25 2024 that the U.S. Food and Drug
Administration (FDA) has communicated to the SABRE (Study to
Advance BMD as a Regulatory Endpoint) project team that a ruling to
qualify the treatment-related change in bone mineral density (BMD)
as a surrogate endpoint for fractures in future trials of new
anti-osteoporosis drugs would be provided within 10 months.
The proposed registrational Phase 3 study for
EB613, Entera’s lead clinical candidate, which is a first-in-class
PTH(1-34) daily tablet treatment for osteoporosis is designed to
meet the quantitative BMD thresholds proposed by SABRE.
“Following our positive placebo-controlled Phase
2 study and multiple Type C and Type D meetings held with FDA from
June 2022 through 2023, we designed our phase 3 study for EB613 to
meet the SABRE quantitative target BMD thresholds which have been
shown to correlate to reductions in vertebral, non-vertebral and
all site fracture risk. We believe EB613 stands as the first
program to potentially avail itself of the landmark SABRE
initiative which is also the first biomarker to potentially be
approved as part of the 2016 21st Century Cures Act. In
November 2023 we issued a press release echoing ASBMR’s
announcement that SABRE had submitted its final qualification
package to FDA for the replacement of fracture as a regulatory
endpoint. Today we are thrilled to echo ASBMR’s announcement that
FDA has set a concrete timetable to issue its ruling. As the first
potential oral tablet osteoanabolic treatment, EB613 holds the
potential to address the treatment chasm in this severe,
potentially lethal disease which remains significantly undertreated
despite efficacious injectable treatments. Fracture rates continue
to rise globally, and we have not seen any new drugs approved for
osteoporosis since 2019, largely due to the ethical concerns, long
duration and costs of fracture endpoint studies. Our discussions
with key clinicians and patient advocacy groups and other key
stakeholders in this ecosystem indicate that an oral anabolic
treatment is warranted and a potential ‘game changer’ for the
estimated 200 million women with osteoporosis globally,” said
Miranda Toledano, CEO of Entera.
The below is an excerpt from ABSMR March 25th
press release1:
According to the Centers for Disease
Control and Prevention, more than 53 million people in the United
States alone have or are at a high-risk for osteoporosis, a bone
disease that develops when bone mass decreases, leading to an
increase in the risk of fractures. Fractures, particularly of the
hip, are considered the most serious consequence of osteoporosis,
which predominantly affects postmenopausal women and older men.
Patients and their families collectively spend an estimated $52
billion annually in healthcare costs for osteoporosis-related bone
breaks, an expense that is predicted to double in the next decades
due to the increased aging of the US population.
“Preventing and treating osteoporosis-related
fractures isn't just about strengthening bones; it's about
enhancing quality of life and saving lives,” added ASBMR President
Laura Calvi, MD. “Embracing BMD as a surrogate endpoint in clinical
trials will revolutionize the journey of novel therapeutic agents
to the clinic, reducing both time and costs, and ultimately it
will lead to improved treatment options for individuals with
osteoporosis.”
About ASBMR-FNIH SABRE
The American Society for Bone and Mineral
Research (ASBMR) is the leading professional, scientific and
medical society established to bring together clinical and
experimental scientists involved in the study of bone, mineral and
musculoskeletal research.
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. Analysis of these data by the project team
indicated a strong association between the treatment-related
increase in bone mineral density, as measured by dual-energy X-ray
absorptiometry (DXA), and the observed reduction in fracture risk.
These findings provide strong evidence that the change in bone
mineral density could 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 Entera Bio
Entera is a clinical stage company focused on
developing oral peptide or protein replacement therapies for
significant unmet medical needs where an oral tablet form holds the
potential to transform the standard of care. The Company leverages
on a disruptive and proprietary technology platform and its
pipeline includes five differentiated, first-in-class oral peptide
programs, expected to enter the into the clinic (Phase 1 to Phase
3) by 2025. 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
pursuant to the FDA’s qualification of a quantitative BMD endpoint
which is expected to occur by January 2025. The EB612 program is
being developed as the first oral PTH(1-34) tablet peptide
replacement therapy for hypoparathyroidism. Entera is also
developing the first oral oxyntomodulin, a dual targeted
GLP1/glucagon peptide, in tablet form for the treatment of obesity;
and first oral GLP-2 peptide tablet as an injection-free
alternative for patients suffering from rare malabsorption
conditions such as short bowel syndrome in collaboration with OPKO
Health. For more information on Entera Bio, visit www.enterabio.com
or follow us on LinkedIn, Twitter, Facebook, Instagram.
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.
_____________________1 FDA Issues Timeline for
Determination on FNIH-ASBMR-SABRE Application to Qualify BMD as a
Surrogate Endpoint in Future Trials of Anti-Osteoporosis Drugs -
American Society for Bone and Mineral Research
Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com
Entera Bio (NASDAQ:ENTX)
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