Entera Bio Reports Preclinical Results For Oral Peptide Programs EB612 And EB618, Advancing Toward Clinical Development

EB612, a first-in-class long-acting PTH(1-34) oral peptide  for hypoparathyroidism, produced robust bioavailability and sustained increases in calcium across three preclinical models; IND is expected in late 2026

EB618, a first-in-class dual GLP-1/glucagon oral receptor agonist (oxyntomodulin) for obesity and metabolic disorders, showed dose-proportional pharmacokinetics and a robust effect on blood glucose in non-human primates

TEL AVIV, June 16, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera"), a leader in the development of oral peptides, reported preclinical data at ENDO 2026, the annual meeting of the Endocrine Society, for its EB612 and EB618 pipeline programs. Both EB612 and EB618 programs are being co-developed with OPKO Health Inc. (NASDAQ:OPK).

"The strength of these results underscores the consistency of our N-Tab® platform to develop proprietary oral peptides across a myriad of targets and indications," said Miranda Toledano, Chief Executive Officer of Entera.

EB612: First-in-Class Oral Long-Acting PTH(1-34) Peptide Tablet for Hypoparathyroidism

EB612 is a proprietary first-in-class long-acting PTH(1-34) analog formulated with Entera's N-Tab® oral peptide platform.  As the first oral peptide replacement therapy, EB612 aims to provide patients with an oral alternative to currently approved or development-stage peptides that require injections.

In a poster presentation entitled "Pre-Clinical Results for EB612: First-in-Class Oral Long-Acting PTH(1-34) Analog as Hormone Replacement Tablet for Patients with Hypoparathyroidism," Entera highlighted the following data for EB612:

• In the thyroparathyroidectomized (TPTx) rat model, the established and widely used preclinical model of hypoparathyroidism, the long-acting PTH(1-34) analog, dosed daily for 7 days, restored serum calcium and reduced phosphate to levels comparable to sham control animals.
• In a minipig model, a single oral dose of EB612 reached maximal plasma levels 2 to 3 hours post-dose, with drug remaining detectable in plasma for more than three days. This sustained pharmacokinetic exposure was associated with a rapid and long-lasting increase in serum Ca in all study animals. The calcemic effect lasted for approximately three days.
• In a non-human primate model, a single oral dose of EB612 produced a robust and sustained increase in serum calcium for approximately three days, accompanied by a correlating suppression of endogenous PTH levels.

EB612 was well tolerated, with no safety concerns identified, and the calcemic effects were consistent with those reported for clinically validated injectable PTH-replacement therapies for hypoparathyroidism.

Ongoing studies are advancing EB612 toward first-in-human clinical evaluation. As announced in February 2026, Entera and OPKO expanded their collaboration to advance EB612 on a 50/50 basis, with an intention to file an investigational new drug (IND) application in late 2026.

EB618: First-in-Class Oral Dual GLP-1/Glucagon receptor agonist (Oxyntomodulin) Tablet for Obesity and Metabolic Disorders

Oxyntomodulin (OXM) is a naturally occurring dual GLP-1/glucagon receptor agonist hormone that regulates appetite and glucose metabolism and promotes weight loss, with additional cardioprotective and anti-fibrotic properties; its therapeutic potential as a native hormone is limited by a short plasma half-life.

The EB618 tablet is a proprietary long-acting OXM analog formulated with Entera's N-Tab® platform.

In a poster presentation at ENDO 2026 entitled "EB618, First-In-Class Oral Tablet of Dual GLP-1/Glucagon Receptor Agonist for Patients with Obesity and Metabolic Disorders: Results from PK-PD Study in Non-Human Primates," Entera reported a single dose pharmacokinetic-pharmacodynamic study in non-human primates:

• EB618 exhibited robust bioavailability, with dose-proportional systemic exposure across three tested tablet strengths and low variability.
• A dose-proportional pharmacologic effect on postprandial blood glucose levels was observed.
• EB618 was well tolerated, with no safety concerns identified, at doses exceeding the anticipated clinical dose range by more than tenfold.

These data support the continued clinical development of EB618 as a potential first-in-class oral once-daily GLP-1/glucagon receptor agonist for the treatment of obesity and metabolic disorders.