Efinopegdutide

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. About Entera Entera is a clinical stage company focused on developing oral peptide and 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 a disruptive and proprietary technology platform (N-Tab®) and its pipeline of first-in-class oral peptide programs. 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 for osteoporosis. 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 also developing the first oral Long Acting PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612), the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedIn, Twitter, and Facebook. Cautionary Statement Regarding Forward Looking StatementsVarious 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, clinical development activities, collaboration arrangements and expected financial and operational results are 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 ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; 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 Statement 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 Entera’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. Company Contact:IR@enterabio.com

Three Late-Breaking Posters Highlight DA-1726, a GLP-1/Glucagon Dual Agonist, and Vanoglipel, a GPR119 Agonist CAMBRIDGE, Mass., May 18, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that three late-breaking abstracts highlighting its cardiometabolic assets, DA-1726, a novel dual oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors for the treatment of obesity, and vanoglipel (DA-1241), a novel G-protein-coupled receptor 119 (GPR119) agonist, have been accepted for poster presentations at the American Diabetes Association's (ADA) 2026 Scientific Sessions. The ADA will be held June 5-8, 2026 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. "Having three late-breaking abstracts accepted for poster presentations at the prestigious ADA conference is a testament to the strength of our cardiometabolic portfolio," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "DA-1726 has the potential to be a differentiated obesity treatment and is currently being evaluated in a 16-week Phase 1 Part 3 titration study designed to reach higher therapeutic doses with improved tolerability. We look forward to reporting data from this trial in the fourth quarter of this year. Our second asset, vanoglipel, has demonstrated broad therapeutic potential across liver and metabolic diseases. The two preclinical posters focused on vanoglipel explore combination therapies with current treatments for metabolic dysfunction-associated steatohepatitis (MASH) and Type 2 diabetes." Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DA-1726, an Oxyntomodulin Analogue: Phase 1 Higher-Dose Cohort Results Presenting Author: Weikai "Chris" Fang, Chief Medical Officer, MetaVia Abstract Control Number: 3102-LB Session: 23-B Obesity—Human Presentation Date: Sunday, June 7, 2026 Presentation Time: 12:30-1:30 pm ET Title: Synergistic Hepatoprotective and Weight-Loss Effects of Vanoglipel and Resmetirom Combination Therapy in a Diet-Induced Obese, Biopsy-Confirmed Mouse Model of MASH Presenting Author: Tae Hyoung Kim, Lead Research Scientist, Dong-A ST Research Center Abstract Control Number: 3043-LB Session: 22-C Integrated Physiology—Liver Presentation Date: Sunday, June 7, 2026 Presentation Time: 12:30-1:30 pm ET Title: Synergistic Effects of Vanoglipel and Metformin on Glycemic Control and Body Weight Reduction in a Diet-Induced Obese Mouse Model Presenting Author: Yuna Chae, Lead Research Scientist, Dong-A ST Research Center Abstract Control Number: 2856-LB Session: 12-D Clinical Therapeutics—Other Therapeutic Agents Presentation Date: Sunday, June 7, 2026 Presentation Time: 12:30-1:30 pm ET A copy of the posters will be available on the Posters section of the MetaVia website after the presentation. About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®), a leading GLP-1 receptor agonist. Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared to tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple ascending dose (MAD) trial in obesity, the 32 mg dose of DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist circumference reduction. About Vanoglipel (DA-1241) Vanoglipel is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes (T2D). Agonism of GPR119 in the gut promotes the release of key gut peptides GLP-1, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. Vanoglipel has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies. The therapeutic potential of vanoglipel has been demonstrated in multiple pre-clinical animal models of MASH and T2D where vanoglipel reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. Furthermore, in Phase 1a, 1b and 2a trials, vanoglipel was well tolerated in both healthy volunteers and those with T2DM. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP-1 receptor agonists such as semaglutide. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit . Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's history of net losses, the sufficiency of its existing cash on hand to fund operations and raising additional capital; adverse global economic conditions; MetaVia's ability to execute on its commercial strategy; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws, regulations or Nasdaq listing rules; the effects of changes to MetaVia's stock price; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE MetaVia Inc. 21% more press release views with Request a Demo