Oxyntomodulin: Research Collaboration Agreement
Sept 12, 2023 12:33:52 GMT
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Post by luxetvox on Sept 12, 2023 12:33:52 GMT
Entera Bio Announces Collaboration with OPKO Biologics to Develop Oral Peptide
Tablet Formulations for Obesity and Intestinal Malabsorption Syndromes
JERUSALEM, Sept. 12, 2023 (GLOBE NEWSWIRE) -- 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
Tablet Formulations for Obesity and Intestinal Malabsorption Syndromes
JERUSALEM, Sept. 12, 2023 (GLOBE NEWSWIRE) -- 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
