Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | N/A | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | - | Undisclosed |
EBP05 is an investigational oral small molecule being developed for hypoparathyroidism and osteoporosis. It is a formulation of oral hPTH(1-34), a parathyroid hormone analog, intended to treat conditions related to bone metabolism. The drug is currently in clinical development and has not been approved by regulatory authorities.
EBP05 is being developed by Entera Bio Ltd., a biopharmaceutical company. Entera Bio is publicly traded on the Nasdaq under the ticker symbol ENTX. The company is focused on oral delivery of peptide and protein therapeutics, with EBP05 being one of its lead product candidates.
EBP05 is in Phase 1 clinical development. The drug has completed a Phase 1 study and a Phase 2 study, but it remains investigational and has not received regulatory approval. The most recent trial listed for EBP05 is a Phase 1 study, indicating the drug is still in early-stage clinical testing.
EBP05 has been studied in two completed clinical trials. NCT04003467 was a six-month Phase 2 study in postmenopausal women with low bone mass, enrolling 161 participants. NCT05965167 was a Phase 1 study comparing new oral tablet formulations to EBP05 and subcutaneous Forteo, enrolling 45 healthy male volunteers.
EBP05 is an oral formulation of hPTH(1-34), which is a parathyroid hormone analog. Parathyroid hormone regulates calcium and phosphate metabolism and stimulates bone formation. By delivering hPTH(1-34) orally, EBP05 aims to provide the therapeutic benefits of parathyroid hormone for conditions like osteoporosis and hypoparathyroidism.
Yes, EBP05 is an oral formulation of hPTH(1-34). The clinical trials listed for EBP05 refer to it as oral hPTH(1-34), and the drug is being developed as an oral alternative to injectable parathyroid hormone therapies. This naming is used in the trial titles and descriptions.