Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a
leader in the development of orally delivered peptides, announced
today that data from the Phase 2 Trial of its lead clinical
compound, EB613 (Oral PTH(1-34) Tablets) for the Treatment of
Post-Menopausal Women with Low BMD or Osteoporosis compared to
placebo were published in the Journal of Bone and Mineral Research
(JBMR).
Miranda Toledano, CEO of Entera, commented, “We
are excited to share that data from our successful Phase 2 study of
EB613 has been accepted and now published in the prestigious JBMR.
We believe EB613 addresses the current treatment gap in
osteoporosis as the first oral, osteoanabolic (bone building)
once-daily tablet treatment due to its unique format and
potential dual mode of action. We remain highly committed to moving
EB613 forward to meet the needs of patients.”
As reported in the Journal of Bone
Mineral Research:
Despite the superior benefits of bone building
(anabolic) agents and guidelines supporting their use, these
medications are used in a minority of patients for whom they are
appropriate, in part because they require daily or monthly
injections, which limit patient acceptance.
An oral anabolic tablet has potential to address
this substantial treatment gap.
In this double-blind, placebo controlled,
dose-finding randomized study, 161 postmenopausal women with low
bone mineral density or osteoporosis were treated with varying
doses of the active part of parathyroid hormone [PTH(1-34), EB613]
or placebo given in daily oral tablets for 6 months.
The highest EB613 oral PTH tablet dose
(2.5 mg), produced an increase in markers of bone formation
while simultaneously decreasing the markers of bone breakdown.
Significant gains in bone mineral density of the
spine and hip were observed at the end of the 6-month study and
there were no significant safety concerns.
The 2.5 mg oral PTH tablet dose was well
tolerated when patients were instructed to titrate up to the full
dose.
We conclude that this PTH tablet might be the
first effective orally administered bone building medication and
should be studied further in treatment of women with
osteoporosis.
Reference:
Liana Tripto-Shkolnik, Auryan Szalat, Gloria
Tsvetov, Vanessa Rouach, Chana Sternberg, Anke Hoppe, Gregory
Burshtein, Hillel Galitzer, Miranda Toledano, Gil Harari, Arthur C
Santora, Felicia Cosman, Oral daily PTH(1-34) tablets (EB613) in
postmenopausal women with low BMD or osteoporosis: a randomized,
placebo-controlled, six-month, phase 2 study, Journal of Bone
and Mineral Research, 2024,
zjae057, https://doi.org/10.1093/jbmr/zjae057
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 (N-Tab™) 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)), 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.
Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com
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