EB618 / Entera Bio, OPKO Health - LARVOL DELTA

Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: OPKO Health, Inc. | Initiation date: Dec 2026 ➔ Jul 2026 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

EB618: First-in-Class Oral Dual GLP-1/Glucagon receptor agonist (Oxyntomodulin) Tablet for Obesity and Metabolic Disorders (GlobeNewswire) - "In a poster presentation at ENDO 2026...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....EB618 was well tolerated, with no safety concerns identified, at doses exceeding the anticipated clinical dose range by more than tenfold."

Preclinical • Obesity

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 (ENDO 2026) - "OPK-88006 is a proprietary (OPKO Health Inc.) long-acting OXM analog that has shown promising activity following subcutaneous administration in rodent models of metabolic disorders...Burshtein G, et al. J Endocr Soc 2025; 9(Supp 1):bvaf149-190"

Clinical • Late-breaking abstract • PK/PD data • Genetic Disorders • Metabolic Disorders • Obesity

Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: OPKO Health, Inc.

New P1/2 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Dual GLP-1/Glucagon OXM Tablet Program (in collaboration with OPKO) (GlobeNewswire) - "Encouraging preclinical data presented at the Endocrine Society (ENDO) 2025 annual meeting: In the abstract...PK data reported from a minipig study show plasma levels of OPK-88006 consistent with those reported in humans for the highest, 2.4 mg subcutaneous dose of Wegovy (semaglutide) weekly injection, a standard of care for the treatment of obesity. An IND for oral OXM is planned for H1 2026."

IND • Preclinical • Obesity

SUPERIOR HEPATOPROTECTIVE EFFECTS OF OPK-88006, A NOVEL GLP-1/GLUCAGON RECEPTOR DUAL AGONIST, TO SEMAGLUTIDE AND SURVODUTIDE IN THE GAN DIET-INDUCED OBESE AND BIOPSY-CONFIRMED MOUSE MODEL OF MASH (AASLD 2025) - "OPK-88006 treatment improved metabolic, biochemical and histopathological parameters of MASH, including hepatic transcriptomic profile, in the GAN DIO-MASH mouse model. Notably, OPK-88006 treatment improved NAFLD Activity Score superior to late-stage clinical candidates semaglutide and survodutide, introducing OPK-88006 as a promising treatment for MASH."

Biopsy • Preclinical • Fibrosis • Genetic Disorders • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • TIMP1

First-in-Class Oral Dual GLP-1/Glucagon Agonist for Patients with Obesity and Metabolic Disorders: In Vivo Pharmacokinetic and Pharmacodynamic Results (ENDO 2025) - "These half-lives were found to be comparable to the reported half-lives of approved oral semaglutide, Rybelsus®, and support a once daily oral OXM treatment regimen. In conclusion, the systemic bioavailability and pharmacologic response, combined with the extended biological half-life of the molecule obtained in rats and minipigs, support further development of oral tablets of OPK-88006 as a potentially first-in-class dual GLP-1/glucagon agonist for the treatment of obesity and metabolic syndromes. A Phase 1 clinical study of this novel oral peptide candidate is currently being planned."

Late-breaking abstract • PK/PD data • Preclinical • Gastrointestinal Disorder • Genetic Disorders • Metabolic Disorders • Obesity

OPKO Health and Entera Bio Abstract for First-in-Class Dual GLP-1/Glucagon Tablet Candidate for Patients with Obesity and Metabolic Disorders Selected for Presentation at the ENDO 2025 Annual Meeting (GlobeNewswire) - "OPKO Health...and Entera Bio...announced that new pharmacologic and pharmacokinetic in vivo data for investigational oral OPK-88006 tablet treatment has been selected for presentation at the ENDO 2025 annual meeting of the Endocrine Society....OPKO and Entera expect to file an Investigational New Drug application with the U.S. Food and Drug Administration later this year for both oral OPK-88006 tablet and a weekly injectable variant of the same molecule, which OPKO intends to develop independently. Phase 1 clinical studies are being planned."

IND • PK/PD data • Preclinical • Metabolic Disorders • Obesity

Superior Hepatoprotective Effects of OPK-88006, a Novel GLP-1/Glucagon Receptor Dual Agonist, to Semaglutide and Survodutide in the GAN Diet-Induced Obese and Biopsy-Confirmed Mouse Model of MASH (ADA 2025) - "OPK-88006 treatment improved metabolic, biochemical and histopathological parameters of MASH, including hepatic transcriptomic profile, in the GAN DIO-MASH mouse model. Notably, OPK-88006 treatment improved NAFLD Activity Score superior to late-stage clinical candidates semaglutide and survodutide, introducing OPK-88006 as a promising treatment for MASH."

Biopsy • Late-breaking abstract • Preclinical • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • TIMP1

Entera Bio Announces First Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity...We expect to file an Investigational New Drug application with the FDA later this year or early in 2026...First GLP-2 Peptide Tablets for Short Bowel Syndrome....We plan to submit abstracts to a major clinical conference with PK/PD of the single daily tablet of GLP-2 in late 2025."

Clinical data • IND • Obesity • Short Bowel Syndrome

Opko Health, Entera Bio ink collaboration agreement to advance oral GLP-1/glucagon tablet candidate into the clinic to treat obesity and metabolic disorders (Pharmabiz) - "Opko Health, Inc., a multinational biopharmaceutical and diagnostics company, and Entera Bio Ltd., a leader in the development of oral peptides and proteins replacement therapies, entered into a collaboration and license agreement to advance into the clinic the first oral dual agonist GLP-1/glucagon peptide as a once-daily tablet treatment for patients with obesity, metabolic and fibrotic disorders. The program combines Opko’s proprietary long-acting oxyntomodulin analog (OPK-88006) and Entera’s proprietary N-Tab technology....Under the terms of the agreement, Opko and Entera will hold 60% and 40% pro-rata ownership interests, respectively, in the program and be responsible for 60% and 40% of the program’s development costs, respectively. In connection with the execution of the agreement, Opko purchased 3,685,226 ordinary shares of Entera for a purchase price equal to $2.17 per share."

Licensing / partnership • Metabolic Disorders • Obesity