teriparatide oral (EB612) / Entera Bio - LARVOL DELTA

Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo (clinicaltrials.gov) - P1/2 | N=45 | Active, not recruiting | Sponsor: Entera Bio Ltd. | Trial completion date: May 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Endocrine Disorders • Hypoparathyroidism • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Assess Safety and Compare PK of New Oral HPTH(1-34) Tablet Formulations Vs. EBP05 Tablets and Subcutaneous Forteo (clinicaltrials.gov) - P1/2 | N=45 | Active, not recruiting | Sponsor: Entera Bio Ltd. | Trial completion date: Mar 2024 ➔ Mar 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Endocrine Disorders • Hypoparathyroidism • Renal Disease

Phase 1 Study Results Of EB612, A First-in-Class Oral PTH(1-34) Analog For The Treatment Of Hypoparathyroidism (ENDO 2024) - P1/2 | "Several PTH replacement therapies for the treatment of hypoparathyroidism patients are currently in development, however these require daily or weekly injections and are cumbersome to titrate in this chronic and heterogenous disease. We previously published positive Phase 2a study results in hypoparathyroid patients using a QID regimen of EB612 tablets. In the current study a new generation of Entera's N-Tab™ technology was utilized to enable a BID tablet dosing regimen."

Late-breaking abstract • P1 data • Endocrine Disorders • Hypoparathyroidism • Metabolic Disorders • Nephrology • Renal Disease

Oral daily PTH(1-34) tablets (EB613) in postmenopausal women with low BMD or osteoporosis: a randomized, placebo-controlled, six-month, phase 2 study. (PubMed, J Bone Miner Res) - "In contrast to subcutaneous PTH, the oral PTH tablet appears to increase BMD rapidly by the dual mechanism of stimulating formation and inhibiting bone resorption. This might be the first effective oral anabolic alternative to subcutaneous administration for the treatment of low BMD or osteoporosis."

Journal • P2 data • Osteoporosis • Pain • Rheumatology • COL1A2

Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo (clinicaltrials.gov) - P1/2 | N=45 | Active, not recruiting | Sponsor: Entera Bio Ltd.

Trial completion date • Trial primary completion date • Endocrine Disorders • Hypoparathyroidism • Renal Disease

Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo (clinicaltrials.gov) - P1/2 | N=45 | Active, not recruiting | Sponsor: Entera Bio Ltd. | Recruiting ➔ Active, not recruiting | Phase classification: P1b ➔ P1/2

Enrollment closed • Phase classification • Endocrine Disorders • Hypoparathyroidism • Renal Disease

Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo (clinicaltrials.gov) - P1b | N=45 | Recruiting | Sponsor: Entera Bio Ltd.

New P1 trial • Endocrine Disorders • Hypoparathyroidism • Renal Disease

A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass (clinicaltrials.gov) - P2; N=161; Completed; Sponsor: Entera Bio Ltd.; Active, not recruiting ➔ Completed; Trial completion date: Oct 2021 ➔ May 2021

Clinical • Trial completion • Trial completion date • Osteoporosis • Rheumatology

A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass (clinicaltrials.gov) - P2; N=161; Active, not recruiting; Sponsor: Entera Bio Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Osteoporosis • Rheumatology

A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass (clinicaltrials.gov) - P2; N=160; Recruiting; Sponsor: Entera Bio Ltd.; Trial completion date: Aug 2020 ➔ Oct 2021; Trial primary completion date: Jun 2020 ➔ Apr 2021

Clinical • Trial completion date • Trial primary completion date • Osteoporosis