Entera Bio Reports Phase 1 Clinical Data of First-in-Class, Oral PTH(1-34) Peptide Candidate (EB612) for Patients with Hypoparathyroidism at ENDO 2024
June 03 2024 - 8:00AM
Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a
leader in the development of orally delivered peptides and small
therapeutic proteins, today announced Phase 1 clinical data for its
hypoparathyroidism focused investigational program, EB612, as
presented on June 1st at the Endocrine Society ENDO 2024 Annual
Meeting.
Entera’s EB612 program aims to provide the first
oral PTH daily tablet hormone replacement therapy for patients
suffering from hypoparathyroidism. Late stage investigational PTH
replacement treatments include TransCon PTH (palopegteriparatide)
by Ascendis Pharma A/S and eneboparatide (AZP-3601) by Amolyt
Pharma. Both these modalities require patients to administer
injections every day. Entera previously published positive Phase 2a
study results in hypoparathyroid patients with four times a day
(QID) regimen (Ish-Shalom, JBMR 2021) of EB612.
The data reported from this Phase 1 clinical
study include pharmacokinetic (PK), pharmacodynamic (PD) and safety
results from the application of a new generation of Entera’s N-Tab™
technology platform and EB612, the active peptide fragment 1-34 of
the N-terminal region of human parathyroid hormone (teriparatide)
dosed twice a day (BID).
Significant systemic exposure was reported
following both administrations of EB612 tablets. Aside from
positive PK measures, sustainable PD effects were reported,
including serum levels of calcium (albumin corrected), phosphate,
and 1,25(OH)2-Vitamin D (reaching +3.9%, -20.8%, and +73.2% change
on average from baseline, respectively) and decreased endogenous
serum PTH(1-84) (reaching -43.0% change on average from baseline).
There were no treatment-emergent Adverse Events of hypercalcemia
reported. There were no treatment-emergent Serious AEs. The only
Study Drug-Related AE was mild headache, reported in two out of
fifteen subjects. No significant findings were observed in blood
and urine lab tests. All vital signs were within the normal
range.
“The encouraging findings from this Phase 1
study reaffirm the ability of our N-Tab™ platform to develop simple
oral tablet treatments of important peptide therapeutics. Here we
suggest that a BID administration of our unmodified PTH(1-34)
peptide may provide a viable alternative for patients with
hypoparathyroidism who require a peptide replacement therapy for
life and are intolerant, adverse or cannot access a daily
injectable product,” said Miranda Toledano, Chief Executive Officer
at Entera.
The poster can be found on the Entera Bio website (Link to
poster)
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 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
Entera Bio (NASDAQ:ENTX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Entera Bio (NASDAQ:ENTX)
Historical Stock Chart
From Jul 2023 to Jul 2024