Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of
orally delivered large molecule therapeutics, announced today the
publication of the results of its previously completed Phase 2a
study of EB612 in the Journal of Bone and Mineral Research. The
article, titled “Safety and Efficacy of Oral Human Parathyroid
Hormone (1-34) in Hypoparathyroidism: An Open-Label Study,”
discussed the results of the four-month study in which EB612 was
evaluated in 2015 as an adjunct to standard calcium and vitamin D
supplement treatment in patients with hypoparathyroidism (HypoPT).
EB612, an oral human parathyroid hormone (1-34) (PTH), has received
Orphan Drug designation from the U.S. Food and Drug Administration
and the European Medicines Agency for the treatment of HypoPT.
The Phase 2a study demonstrated the safety and
tolerability of EB612 administered four times daily for 16 weeks to
patients with HypoPT. The study achieved its primary and secondary
endpoints, including a reduction in calcium supplements, reductions
in serum phosphate and 24-hour urine calcium excretion, maintenance
of albumin-adjusted serum calcium (ACa) within the reference range,
and an improvement in quality of life. Specific results of this
trial included:
- A significant
reduction of 42% (p=0.001) from baseline in median calcium
supplement use;
- Maintenance of
median ACa levels above the lower target level for HypoPT patients
(>7.5 mg/dL) throughout the study;
- A rapid decline
of 23% (p=0.0003) in median serum phosphate levels 2 hours
following the first dose that was maintained within the normal
range for the duration of the study;
- A notable median
decrease of 21% (p=0.07) in 24-hour urine calcium excretion between
the first and last treatment days; and
- An increase in
quality of life score of 5% (p=0.03) from baseline by the end of
the treatment period.
In this study, patients were titrated up to a
maximum of 12 EB612 0.75 mg tablets a day (total daily dose of 9
mg) by the investigator, according to each subject’s ACa, and
supplement treatment regimen. Of the 19 enrolled subjects, 17
completed the trial (of which 15 were per protocol). No
drug-related serious adverse events were reported and most of the
adverse events were not considered study drug-related.
“The publication of our Phase 2a EB612 study
results in this leading peer-reviewed journal support our HypoPT
development program and the value of our platform technology. The
availability of an oral PTH is expected to improve compliance, as
well as therapeutic impact and may offer patients with HypoPT a
much-needed alternative to the currently available parathyroid
hormone replacement therapy options which are administered via
daily injections. We are currently working on improved formulations
of EB612 and the design of the next clinical trial which we expect
to initiate in 2022,” stated Entera CEO Spiros Jamas. “In addition,
through the use of our previously announced at-the-market equity
program, we have continued to strengthen our balance sheet in the
first quarter of 2021, and we are now funded into the fourth
quarter of 2021.”
The full peer-reviewed publication will be
available on Entera’s website once the final article is released
for publication and can be found here.
About Hypoparathyroidism
Hypoparathyroidism (HypoPT) is a rare condition
in which the body produces insufficient amounts of parathyroid
hormone. Individuals with HypoPT typically exhibit abnormally low
levels of calcium in the blood (hypocalcemia), and high levels of
phosphate in the blood (hyperphosphatemia). They also develop
increased urine calcium (hypercalciuria). HypoPT is estimated to
affect approximately 77,000 individuals in the United States.
Historically, the treatments for HypoPT have been calcium
supplements and active vitamin D (calcitriol or alfacalcidol).
Phosphate binders that inhibit phosphate absorption and thiazide
diuretics that reduce urine calcium are occasionally added. It is
often difficult to titrate the dose of both calcium supplements and
active vitamin D to reduce symptoms of hypocalcemia without
producing increased urine calcium or hypercalcemia with tissue
calcification during chronic use, which can result in kidney injury
and significant healthcare costs. Moreover, the high doses of
calcium supplements may produce stomach and gastrointestinal
symptoms as well as other symptoms that negatively affect a
patient’s quality of life. A once-daily, injectable form of
parathyroid hormone has been approved by the FDA and EMA for the
treatment of hypocalcemia in patients with HypoPT.
About Entera Bio
Entera is a leader in the development of orally
delivered large molecule therapeutics for use in areas with
significant unmet medical need where adoption of injectable
therapies is limited due to cost, convenience and compliance
challenges for patients. The Company’s proprietary, oral drug
delivery technology is designed to address the technical challenges
of poor absorption, high variability, and the inability to deliver
large molecules to the targeted location in the body through the
use of a synthetic absorption enhancer to facilitate the absorption
of large molecules, and protease inhibitors to prevent enzymatic
degradation and support delivery to targeted tissues. The Company’s
most advanced product candidates, EB613 for the treatment of
osteoporosis and EB612 for the treatment of hypoparathyroidism are
in Phase 2 clinical development. Entera also licenses its
technology to biopharmaceutical companies for use with their
proprietary compounds and, to date, has established a collaboration
with Amgen Inc. For more information on Entera Bio, visit
www.enterabio.com.
Forward Looking Statements
Various statements in this release are
“forward-looking statements” under the securities laws. 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 our
interpretation of the interim data from the ongoing Phase 2
clinical trial of EB613, the timing of data readouts from the
ongoing Phase 2 clinical trial of EB613, 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; a
possible suspension of the Phase 2 clinical trial of EB613 for
clinical or data-related reasons; the impact of COVID-19 on
Entera’s business operations including the ability to collect the
necessary data from the Phase 2 trial of EB613; the potential
disruption and delay of manufacturing supply chains, loss of
available workforce resources, either by Entera or its
collaboration and laboratory partners, due to travel restrictions,
lay-offs or forced closures or repurposing of hospital facilities;
impacts to research and development or clinical activities that
Entera is contractually obligated to provide, such as pursuant to
Entera’s agreement with Amgen; overall regulatory timelines, if the
FDA or other authorities are closed for prolonged periods, choose
to allocate resources to review of COVID-19 related drugs or
believe that the amount of Phase 2 clinical data collected are
insufficient to initiate a Phase 3 trial, or a meaningful
deterioration of the current political, legal and regulatory
situation in Israel or the United States; the availability, quality
and timing of the data from the Phase 2 clinical trial of EB613 in
osteoporosis patients; the ability find a dose that demonstrates
the comparability of EB613 to FORTEO in the ongoing Phase 2
clinical trial of EB613; the size and growth of the potential
market for EB613 and Entera’s other product candidates including
any possible expansion of the market if an orally delivered option
is available in addition to an injectable formulation; the results
of formulation development work on EB612 the impact on future
clinical trials, the scope, progress and costs of developing
Entera’s product candidates including EB612 and GLP-2; 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 expectations regarding its expenses, revenue, cash
resources, liquidity and financial condition; Entera’s ability to
raise additional capital; Entera’s interpretation of FDA feedback
and guidance and how such guidance may impact its clinical
development plans; 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 “Special Note Regarding
Forward-Looking Statements,” “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” sections of Entera’s annual and current filings which
are on file with the SEC and available free of charge on the SEC’s
website at http://www.sec.gov. Additional factors may be set forth
in those sections of Entera’s Quarterly Report on Form 6-K for the
quarter ended September 30, 2020, filed with the SEC in the fourth
quarter of 2020. In addition to the risks described above and in
Entera’s annual report on Form 20-F and current reports on Form 6-K
and other filings with the SEC, other unknown or unpredictable
factors also could affect Entera’s results. 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 in
such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking
statements attributable to Entera or any person acting on its
behalf are expressly qualified in their entirety by the cautionary
statements contained or referred to herein. Entera cautions
investors not to rely too heavily on the forward-looking statements
Entera makes or that are made on its behalf. The information in
this release is provided only as of the date of this release, and
Entera undertakes no obligation, and specifically declines any
obligation, to update or revise publicly any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contact:
Jonathan Lieber, CFO
Tel: +001 617-362-3579
jon@enterabio.com
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