Entera Bio Announces Collaboration with OPKO Biologics to Develop Oral Peptide Tablet Formulations for Obesity and Intestinal Malabsorption Syndromes
12 Setembro 2023 - 9:30AM
Entera Bio Ltd. (NASDAQ: ENTX, “Entera”) and OPKO Biologics, Inc.,
a subsidiary of OPKO Health, Inc. (NASDAQ: OPK, “OPKO”) have
entered into a Research Collaboration Agreement. Under the terms of
the Agreement, OPKO will supply its proprietary long-acting GLP-2
peptide and certain Oxyntomodulin (OXM) analogs for the development
of oral tablet formulations using Entera’s proprietary oral
delivery technology.
It is challenging to administer peptides orally
due to their rapid degradation in the gastrointestinal tract and
negligible permeability. Treatment with Glucagon-Like Peptide-2
(GLP-2) analogs has been shown to improve the absorption of
nutrients in patients with short bowel syndrome (SBS) and reduce
parenteral support requirements. Teduglutide, the only approved
GLP-2 analog, requires daily subcutaneous injections. In SBS
patients, oral drug delivery is particularly challenging because
the site of absorption, the intestine, is short and less
functional. Entera recently published pre-clinical data
demonstrating that its oral peptide delivery platform enables
gastric absorption of teduglutide, as a convenient potential tablet
alternative to daily injections.
Oxyntomodulin is a naturally occurring peptide
hormone found in the colon, with glucagon-like-peptide 1
(GLP-1) and glucagon dual agonist activity which suppresses
appetite and induces weight loss. OPKO has developed several
proprietary, modified OXM analogs as potential candidates for
treating obesity, including an injectable pegylated peptide which
demonstrated significant reductions in weight loss and decreased
plasma triglyceride levels in a 420 patient phase 2B study.
Under the terms of the agreement, Entera and
OPKO will each be responsible for specific phases of development of
the two oral peptides to the point of demonstrated in vivo
feasibility. Further details of the agreement were not made
public.
"This collaboration with OPKO is important for
Entera as it enables us to expand our oral delivery technology
across additional high value peptides,” said Miranda Toledano,
Chief Executive Officer of Entera. "OPKO is a leader in the
development and commercialization of highly differentiated,
long-acting peptides. Most important, we share a common vision to
create first in class peptide treatments to help patients better
manage serious, undertreated chronic diseases in a more comfortable
way.”
“This collaboration fits with OPKO’s strategy to
expand our pipeline to develop orally administered tablet
presentations of long-acting peptides. Working with Entera and its
unique oral delivery platform compliments our previous experience
in the development of NGENLA, our once weekly human growth hormone
product, in collaboration with Pfizer and serves to enhance the
diversity and strength of our development portfolio. We look
forward to working with Entera,” said Phillip Frost, Chairman and
Chief Executive Officer of OPKO Health.
About Entera Bio
Entera focuses on significant unmet medical
needs where a daily mini tablet form of a peptide treatment or
replacement therapy holds the potential to transform the standard
of care. The Company’s oral hPTH*(1-34) teriparatide mini tablets
have been administered to a total of 240 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
synthetic hPTH (1-34)), is being developed as the first oral,
osteoanabolic (bone building) once a day 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 expects to report results from a
phase 1B PK study of novel PTH formulations using its proprietary,
next generation oral delivery platform in the second half of 2023.
In May 2023, Entera announced pre-clinical results from its oral
GLP-2 program which is being developed as an injection-free
alternative for patients suffering from short bowel syndrome and
other severe intestinal and malabsorption metabolic conditions. 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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