Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as hPTH(1-34), Teriparatide
EBP05 · 2 trials · 4 indications
Determine the change in P1NP from baseline during treatment with oral EBP05 for 3 months compared with the change during treatment with placebo
Pharmacokinetic parameter - plasma hPTH(1-34) in pg/mL
Pharmacokinetic parameter - total drug exposure at different time points up to 360 min. post dose
Pharmacokinetic parameter - total drug exposure in pg/mL over time from 0 extrapolated to infinity
Pharmacokinetic parameter - Percent of AUC0-inf extrapolated to confirm reliability
Pharmacokinetic parameter - hPTH (1-34) maximal concentration in pg/mL (Cmax)
Pharmacokinetic parameter - time in minutes to reach max. concentration of hPTH(1-34)
Pharmacokinetic parameter - elimination rate constant in pg/mL, fraction of drug eliminated per time-point up to 360 min. post dose
Pharmacokinetic parameter - terminal elimination half life of hPTH(1-34) in minutes
Pharmacokinetic parameter - time of the last measurable concentration of hPTH(1-34) in minutes
Pharmacokinetic parameter - Coefficient of Variance (CV%) of hPTH (1-34)
Pharmacokinetic parameter
Pharmacokinetic parameter - up to 360 min. post dose
Safety parameter (group mean at each time point up to 360 min. post dose)
Safety parameter (group mean at each time point up to 360 min. post dose)
Safety parameter (group mean at each time point up to 360 min. post dose)
Safety parameter (group mean at each time point up to 360 min. post dose)
Safety parameter - AEs observed over duration of study participation
Safety parameter - SAEs observed over duration of study participation
| Arm | Type | Description |
|---|---|---|
| EBP05 1.5mg | EXPERIMENTAL | subjects will be randomly assigned to receive 3 tablets of EBP05 containing 0.5mg hPTH(1-34) orally each day for 6 months |
| Placebo for EBP05 0.5mg (1, 2, 3 or 5) | EXPERIMENTAL | subjects will be randomly assigned to receive 3 or 5 tablets of matching EBP05 placebo orally each day for 6 months |
| EBP05 2.5mg | EXPERIMENTAL | subjects will be randomly assigned to receive 5 tablets of EBP05 containing 0.5mg hPTH(1-34) orally each day for 6 months |
| EBP05 0.5mg | EXPERIMENTAL | subjects will be randomly assigned to receive 1 tablet of EBP05 containing 0.5mg hPTH(1-34) orally each day for 6 months |
| EBP05 1.0mg | EXPERIMENTAL | subjects will be randomly assigned to receive 2 tablets of EBP05 containing 0.5mg hPTH(1-34) orally each day for 6 months |
| Treatment A EBP05 2.5 mg | EXPERIMENTAL | Single dose of oral EBP05 2.5 mg |
| Treatment B EBP05 1.5 mg | EXPERIMENTAL | Single dose of oral EBP05 1.5 mg |
| Treatment C Forteo 0.02 mg | EXPERIMENTAL | Single SC injection of Forteo 0.02 mg |
| Treatment D EBP11 1.5 mg | EXPERIMENTAL | Single dose of oral EBP11 1.5 mg |
| Treatment E EBP11 BID (dose determined after IA) | EXPERIMENTAL | BID administration of oral EBP11 2.5 mg tablets |
| Treatment F EBP11 BID (dose determined after IA) | EXPERIMENTAL | BID administration of oral EBP11 tablets 1.5 mg tablets (3 x 0.5 mg tablets) as first dose and 2.5 mg (5 x 0.5 mg tablets) as second dose. |
| Treatment G EBP11 1.5 mg | EXPERIMENTAL | Single dose of oral EBP11 1.5 mg |
| Treatment I EBP22 1.5 mg | EXPERIMENTAL | Single dose of oral EBP22 1.5 mg |
| Treatment J EBP22 1.5 mg | EXPERIMENTAL | Single dose of oral EBP22 1.5 mg |
| Treatment K EBP05 1.5 mg | EXPERIMENTAL | Single dose of oral EBP05 1.5 mg |
| Treatment L EBP05 2.5 mg | EXPERIMENTAL | Single dose of oral EBP05 2.5 mg |
| Treatment M Forteo 0.02 mg | EXPERIMENTAL | Single SC injection of Forteo 0.02 mg |
| Treatment N EBP05 3.0 mg | EXPERIMENTAL | Single dose of oral EBP05 3.0 mg |
| Treatment H EBP22 2.5 mg (5 x 0.5 mg tablets) | EXPERIMENTAL | Single dose of oral EBP22 2.5 mg (5 x 0.5 mg tablets) |
| Treatment O EBP11-F4 2.5 mg | EXPERIMENTAL | Single dose of oral EBP11-F4 2.5 mg |
| Treatment P EBP11-F2 1.5 mg | EXPERIMENTAL | Single dose of oral EBP11-F2 1.5 mg |
| Treatment Q EBP11-F4 2.5 mg | EXPERIMENTAL | Single dose of oral EBP11-F4 2.5 mg |
| Treatment R EBP11-F5 3.0 mg | EXPERIMENTAL | Single dose of oral EBP11-F5 3.0 mg |
| Treatment S EBP11-F1 1.0 mg | EXPERIMENTAL | Single dose of oral EBP11-F1 1.0 mg |
| Name | Type | Description |
|---|---|---|
| EBP05 | DRUG | tablets |
| Placebo of EBP05 | DRUG | tablets |
| Forteo 0.02 mg | DRUG | Subcutaneous injection |
| EBP11 | DRUG | Oral tablets |
| EBP22 | DRUG | Oral tablets |
| EBP11-F2 | DRUG | Oral tablets |
| EBP11-F4 | DRUG | Oral tablets |
| EBP11-F1 | DRUG | Oral tablets |
| EBP11-F5 | DRUG | Oral tablets |
Inclusion criteria: 1. Female subjects above 50 years of age 2. Signed Informed Consent Form 3. Able to adhere to the visit schedule and protocol requirements 4. At least 3 years post menopause (physiological or surgical) 5. Women who are less than 55 years old need to have estradiol and LH in the ...
EBP05 is an oral small molecule being developed by Entera Bio Ltd. as a form of parathyroid hormone PTH(1-34). It is designed to be taken as a tablet rather than by injection, and it is being studied in hypoparathyroidism and osteoporosis.
EBP05 is being studied for hypoparathyroidism and osteoporosis. Clinical work has focused on postmenopausal women with low bone mass and on healthy male volunteers, with trial conditions also listing fractures and other bone disease. It is investigational and has not been approved for any use.
EBP05 delivers PTH(1-34), a peptide corresponding to the active portion of human parathyroid hormone. The drug is an oral formulation of this peptide, so its target class is peptide hormone therapy rather than a conventional small molecule receptor target.
EBP05 is developed by Entera Bio Ltd., which trades under the ticker ENTX. The company is advancing the oral PTH(1-34) program in endocrine and bone indications.
EBP05 is in Phase 1 clinical development. A Phase 2 study of oral hPTH(1-34) in postmenopausal women with low bone mass has also been completed, but the program remains investigational and no regulatory approval has been granted.
EBP05 has been evaluated in completed trials including NCT05965167, a Phase 1 study comparing oral hPTH(1-34) tablet formulations with EBP05 tablets and subcutaneous Forteo, and NCT04003467, a six-month Phase 2 study in postmenopausal women with low bone mass.