Interim Results from Ongoing Clinical Study Confirm EB613 Optimized Profile for Osteoporosis Treatment and Potential for Entera’s Next Generation Oral Peptide Platform
November 29 2023 - 8:30AM
Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a
leader in the development of orally delivered peptides and
therapeutic proteins, reported today interim data from an ongoing
Phase 1 study designed to assess and compare the pharmacokinetic
(PK) and early pharmacodynamic (PD) profile of current and several
next generation compositions of its oral peptide platform
(NCT05965167).
EB613 Continues to Display an Optimal
Profile as First-in-Class Oral PTH(1-34) Peptide for
Osteoporosis
The Phase 1 study first compared the PK profile
of Entera’s Phase 3 candidate, oral once-daily PTH(1-34)
mini-tablets (EB613, a.k.a. EBP05 formulation) with subcutaneous
(SC) PTH(1-34) 20 g (Forteo®). Consistent with previously reported
PK and bioavailability data, EBP05 induced a rapid and
dose-proportional increase in plasma drug concentrations of
PTH(1-34) at all doses tested. The target bioavailability of PTH
(1-34) with EB613 at doses of 1.5 mg and 2.5 mg, covering the dose
range planned for phase 3 was met. Additionally, EB613 exhibited
consistent and statistically significant (p<0.05) effects across
all early PD markers such as plasma levels of endogenous PTH(1-84),
serum calcium, phosphorus, and 1,25-dihydroxyvitamin D.
“EB613’s reproducible PK profile across all our
clinical studies, irrespective of age and gender, demonstrates the
superiority of our platform to consistently deliver oral peptides
in a small and convenient tablet form. Although the amino acid
sequence in our oral PTH(1-34) is identical to commercially
available injectable teriparatide, there is a clear difference in
the exposure profile. EB613 appears to produce a shorter duration
of osteoblast and osteoclast activation, which is essential for
osteoporosis treatment. EB613 induces the “pulsatile” exposure
required to simultaneously stimulate bone formation (anabolic) with
a mild anti-resorptive property, as compared to Forteo®. This
exciting mechanism is consistent with the primary endpoint, bone
turnover data reported from our placebo-controlled Phase 2 study in
post-menopausal women at high risk of osteoporosis and potentially,
the reason we see more rapid BMD increases at 6 months of treatment
with EB613, especially at the total hip and proximal femur sites,”
said Miranda Toledano, Chief Executive Officer of Entera.
Next Generation Platform Demonstrates Robust
Bioavailability with Novel Oral Peptide Compositions
The Phase 1 PK study also assessed novel
compositions comprising PTH(1-34) as a model peptide to test
Entera’s proprietary, next generation platform.
The new compositions show enhanced
bioavailability (BA) versus our first-generation platform, as
expected from pre-clinical data. All formulations demonstrated a
consistent PK profile to EBP05 with rapid absorption and
elimination; and induced fast PD responses increasing calcium,
vitamin D levels along with reducing phosphate and endogenous
PTH(1-84).
Entera expects to unveil additional data at an
upcoming conference.
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 255 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. 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.
Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com
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