Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EB612 · 1 trial · 1 indication
Pharmacokinetic Parameter
Pharmacodynamic Parameter
Pharmacodynamic Parameter
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Intervention: EB612 (EBP05) 2.25 mg orally (PO) four times a day (QID) (approximately 5 hours apart) for 4 doses, for a total dose of 9 mg per day |
| Treatment B | EXPERIMENTAL | Intervention: EB612 (EBP05) 2.25 mg PO twice a day (BID) (approximately 10 hours apart) for 2 doses, for a total dose of 4.5 mg per day |
| Treatment C | ACTIVE_COMPARATOR | Intervention: NATPARA/NATPAR PTH(1-84) 100 μg subcutaneous injection once daily (single dose) |
| Treatment D | EXPERIMENTAL | Intervention: EB612 (EBP05) 2.25 mg PO TID (dose 1 and dose 2 approximately 10 hours apart; dose 2 and dose 3 approximately 5 hours apart- TID schedule option 2), for a total dose of 6.75 mg per day |
| Treatment E - EB612 (EBP05) | EXPERIMENTAL | Intervention: EB612 (EBP05) 0.75 mg PO TID (dose 1 and dose 2 approximately 10 hours apart; dose 2 and dose 3 approximately 5 hours apart- TID schedule option 2), for a total dose of 2.25 mg per day |
| Name | Type | Description |
|---|---|---|
| EB612 (EBP05) | DRUG | Entera Bio's proprietary drug for the administration of PTH(1-34) orally |
| NATPARA/NATPAR | DRUG | A PTH replacement (PTH \[1-84\]; NATPARA (Shire-NPS Pharmaceuticals, Inc., Lexington, Massachusetts) was approved by the United States (US) Food and Drug Administration (FDA) in April 2015 / NATPAR (Shire Pharmaceuticals Ltd., Dublin, Ireland) was approved by the European Medicines Agency in April 2017 for use as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Like many other hormonally active peptides, PTH (1 84); NATPARA is parenterally administered. In this protocol when a specific formulation is referenced (e.g. NATPARA) it may be read interchanged with the alternate formulation (e.g. NATPAR). |
-Criteria for Inclusion: 1. Confirmed diagnosis of primary hypoparathyroidism, as defined by the European Society of Endocrinology as a patient with hypocalcemia and inappropriately low PTH levels. If the source of hypoparathyroidism is surgical or iatrogenic, diagnosis must be for more than 1 year...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | eneboparatide |
| Ascendis Pharma A/S | ASND | 3 | PHASE3 | Palopegteriparatide Experimental Arm, Palopegteriparatide Control Arm |
| MBX Biosciences, Inc. | MBX | 1 | PHASE2 | 400 µg of MBX 2109 once-weekly by, 200-1600 µg of MBX 2109 once-weekly by |
EB612 is an investigational oral small molecule being developed for the treatment of hypoparathyroidism, a condition characterized by insufficient parathyroid hormone. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
EB612 is an oral formulation of parathyroid hormone (PTH) 1-34, designed to replace or supplement the missing hormone in patients with hypoparathyroidism. It targets the parathyroid hormone signaling pathway to help regulate calcium and phosphate levels.
EB612 is being developed by Entera Bio Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ENTX. The company is focused on oral delivery of peptides and proteins.
EB612 is in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug remains investigational and has not received FDA approval. Further studies would be needed to establish its safety and efficacy.
EB612 has been studied in one completed Phase 2 trial, NCT03516773, titled 'Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism.' The trial enrolled 20 patients in Israel and was an active-controlled, randomized study.