Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04003467 | A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass | PHASE2 | COMPLETED | 161 | — | — | Jun 30, 2019 | May 11, 2021 | Jun 28, 2021 | 4 | Israel |
Determine the change in P1NP from baseline during treatment with oral EBP05 for 3 months compared with the change during treatment with placebo
| 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 |
| Name | Type | Description |
|---|---|---|
| EBP05 | DRUG | tablets |
| Placebo of EBP05 | DRUG | 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 | NA | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | — | Undisclosed |