teriparatide oral (EB613) / 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 | N=45 | Completed | Sponsor: Entera Bio Ltd. | Phase classification: P1/2 ➔ P1 | Recruiting ➔ Completed

Phase classification • Trial completion • 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 | Recruiting | Sponsor: Entera Bio Ltd. | Active, not recruiting ➔ Recruiting

Enrollment open • Endocrine Disorders • Hypoparathyroidism • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Entera Bio’s EB613 Demonstrates Early Impact on Both Trabecular and Cortical Bone Compartments with 6 Months of Treatment in Post-Menopausal Women with Osteoporosis - Highlighted as Oral Presentation at WCO-IOF ESCEO (GlobeNewswire) - P2 | N=161 | NCT04003467 | Sponsor: Entera Bio Ltd.| "The Phase 2 study randomized 161 postmenopausal women with low bone mass or osteoporosis to placebo or four EB613 doses levels for 6 months. Previously published changes in biochemical markers of bone turnover suggest a dual effect to stimulate formation and inhibit resorption. In addition, EB613 significantly increased BMD at each measured skeletal site as compared with baseline and placebo. To explore the dual actions of EB613 further, 3D-DXA analysis was performed....After 6 months of treatment, the findings showed increases with EB613 compared with placebo in a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. The evaluation, 'Showed a fairly broad distribution of bone loss in the femur with placebo and a similarly broad distribution of bone gain in the femur with EB613...'"

P2 data • Osteoporosis

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

EFFECTS OF EB613 TABLETS [ORAL PTH(1-34)] ON TRABECULAR AND CORTICAL BONE USING 3D-DXA: POST-HOC RESULTS FROM PHASE 2 STUDY Accepted for Oral Presentation at World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (GlobeNewswire) - "Entera Bio Ltd...today announced that the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) Scientific Programme Committee has accepted both submitted abstracts related to EB613 for presentation at the WCO-IOF-ESCEO congress...In a Placebo-controlled Phase 2 study, 6 months of EB613 treatment demonstrated fast onset of action and robust increases in BMD at all skeletal sites."

P2 data • Osteoporosis