Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as EB612 (EBP05)
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 |
|---|---|---|---|---|
| Ascendis Pharma A/S | ASND | 4 | PHASE3 | Palopegteriparatide |
| AstraZeneca PLC | AZN | 1 | PHASE3 | eneboparatide |
| MBX Biosciences, Inc. | MBX | 2 | PHASE3 | Canvuparatide |
| BridgeBio Pharma, Inc. | BBIO | 1 | PHASE3 | Encaleret |
EB612 is an investigational oral small molecule developed by Entera Bio Ltd. (ticker ENTX) for the treatment of hypoparathyroidism, an endocrine disorder. It is designed as an oral formulation of PTH(1-34) and has completed a Phase 2 clinical trial. EB612 is also known as EBP05.
EB612 is being developed to treat hypoparathyroidism, a condition in which the body does not produce enough parathyroid hormone. It is an oral small molecule formulation of PTH(1-34) intended to replace or supplement parathyroid hormone. The drug is investigational and has completed a Phase 2 study in patients with this condition.
EB612 targets PTH(1-34), a peptide corresponding to the active fragment of parathyroid hormone. By delivering PTH(1-34) orally, the drug is intended to act on the same pathway that parathyroid hormone normally regulates in calcium and phosphate balance. The molecular target class is peptide.
EB612 is being developed by Entera Bio Ltd., a biopharmaceutical company whose ticker symbol is ENTX. Entera Bio is focused on oral peptide and protein therapeutics. The company has advanced EB612 into Phase 2 clinical development for hypoparathyroidism.
EB612 is in Phase 2 development. It is investigational and has not been approved by the FDA. One Phase 2 trial has been completed, and no active trials are currently listed. The completed study was an active-controlled, randomized Phase 2 trial in patients with hypoparathyroidism.
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, was randomized and active-controlled, and included adults 18 years and older of all sexes.
Yes, EB612 is also known as EBP05. Both names refer to the same oral PTH(1-34) candidate developed by Entera Bio Ltd. (ENTX) for hypoparathyroidism. The alternative designation EBP05 may appear in company materials and earlier references to the program.