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EBP05

Phase 2

Osteoporosis | Small molecule | Endocrine |Entera Bio Ltd.|Last Updated: Feb 17, 2026

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Market & Valuation
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment161
FDA Designations
No designations recorded
Clinical trial landscape

EBP05 · 2 trials · 4 indications

Phase 2 1Phase 1 1
NCT04003467A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone MassOsteoporosis
COMPLETED161 Analytics
PHASE2COMPLETED
A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass
Osteoporosis
NCT04003467161
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Study Endpoints
Primary Endpoints
Mean % change in P1NP from baseline after 3 months of treatment
baseline, 3 months

Determine the change in P1NP from baseline during treatment with oral EBP05 for 3 months compared with the change during treatment with placebo

Assessment of the pharmacokinetic profile of plasma hPTH(1-34) after single or twice daily oral administration for treatment regimen as listed under Arms and Interventions at 5, 10, 15, 20, 40, 50, 60, 75, 90, 105, 120, 180, 240, 360 min. post dose
6 hours

Pharmacokinetic parameter - plasma hPTH(1-34) in pg/mL

Calculation of plasma levels of hPTH(1-34) AUC0-t for each treatment regimen
6 hours

Pharmacokinetic parameter - total drug exposure at different time points up to 360 min. post dose

Calculation of plasma levels of hPTH(1-34) AUC0-inf for each treatment regimen
6-14 hours

Pharmacokinetic parameter - total drug exposure in pg/mL over time from 0 extrapolated to infinity

Calculation of plasma levels of hPTH(1-34) AUC%extrap for each treatment regimen
6-14 hours

Pharmacokinetic parameter - Percent of AUC0-inf extrapolated to confirm reliability

Calculation of plasma levels of hPTH(1-34) Cmax for each treatment regimen
6-14 hours

Pharmacokinetic parameter - hPTH (1-34) maximal concentration in pg/mL (Cmax)

Calculation of plasma levels of hPTH(1-34) Tmax for each treatment regimen
6-14 hours

Pharmacokinetic parameter - time in minutes to reach max. concentration of hPTH(1-34)

Calculation of plasma levels of hPTH(1-34) Kel for each treatment regimen
6 hours

Pharmacokinetic parameter - elimination rate constant in pg/mL, fraction of drug eliminated per time-point up to 360 min. post dose

Calculation of plasma levels of hPTH(1-34) t½ for each treatment regimen
6-14 hours

Pharmacokinetic parameter - terminal elimination half life of hPTH(1-34) in minutes

Calculation of plasma levels of hPTH(1-34) Tlast for each treatment regimen
6-14 hours

Pharmacokinetic parameter - time of the last measurable concentration of hPTH(1-34) in minutes

Assessment of inter-subject variability of hPTH(1-34) for each treatment regimen
6-14 hours

Pharmacokinetic parameter - Coefficient of Variance (CV%) of hPTH (1-34)

Calculation of dose proportionality for hPTH(1-34) for relevant treatment regimen
6 hours

Pharmacokinetic parameter

Assessment of the duration of exposure to hPTH(1-34) in minutes
6 hours

Pharmacokinetic parameter - up to 360 min. post dose

Vital Signs - body temperature (Celsius)
6 hours

Safety parameter (group mean at each time point up to 360 min. post dose)

Vital Signs - respiratory rate (breaths per minute)
6 hours

Safety parameter (group mean at each time point up to 360 min. post dose)

Vital Signs - blood pressure (systolic/diastolic mmHg)
6 hours

Safety parameter (group mean at each time point up to 360 min. post dose)

Vital Signs - heart rate (beats per minute)
6 hours

Safety parameter (group mean at each time point up to 360 min. post dose)

Incidence of Treatment-Emergent Adverse Events as assessed by the Principle Investigator
6-14 hours

Safety parameter - AEs observed over duration of study participation

Incidence of Serious Adverse Events (SAEs) as assessed by the Principle Investigator
6-14 hours

Safety parameter - SAEs observed over duration of study participation

Secondary Endpoints
Mean % change in BMD (lumbar) from baseline after 6 months of treatment
baseline, 6 months
Mean % change in BMD (Femoral Neck and Total Hip) from baseline after 6 months of treatment
baseline, 6 months
Mean % change in P1NP from baseline after 6 months of treatment
baseline, 6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EBP05 1.5mgEXPERIMENTALsubjects 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)EXPERIMENTALsubjects will be randomly assigned to receive 3 or 5 tablets of matching EBP05 placebo orally each day for 6 months
EBP05 2.5mgEXPERIMENTALsubjects will be randomly assigned to receive 5 tablets of EBP05 containing 0.5mg hPTH(1-34) orally each day for 6 months
EBP05 0.5mgEXPERIMENTALsubjects will be randomly assigned to receive 1 tablet of EBP05 containing 0.5mg hPTH(1-34) orally each day for 6 months
EBP05 1.0mgEXPERIMENTALsubjects 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 mgEXPERIMENTALSingle dose of oral EBP05 2.5 mg
Treatment B EBP05 1.5 mgEXPERIMENTALSingle dose of oral EBP05 1.5 mg
Treatment C Forteo 0.02 mgEXPERIMENTALSingle SC injection of Forteo 0.02 mg
Treatment D EBP11 1.5 mgEXPERIMENTALSingle dose of oral EBP11 1.5 mg
Treatment E EBP11 BID (dose determined after IA)EXPERIMENTALBID administration of oral EBP11 2.5 mg tablets
Treatment F EBP11 BID (dose determined after IA)EXPERIMENTALBID 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 mgEXPERIMENTALSingle dose of oral EBP11 1.5 mg
Treatment I EBP22 1.5 mgEXPERIMENTALSingle dose of oral EBP22 1.5 mg
Treatment J EBP22 1.5 mgEXPERIMENTALSingle dose of oral EBP22 1.5 mg
Treatment K EBP05 1.5 mgEXPERIMENTALSingle dose of oral EBP05 1.5 mg
Treatment L EBP05 2.5 mgEXPERIMENTALSingle dose of oral EBP05 2.5 mg
Treatment M Forteo 0.02 mgEXPERIMENTALSingle SC injection of Forteo 0.02 mg
Treatment N EBP05 3.0 mgEXPERIMENTALSingle dose of oral EBP05 3.0 mg
Treatment H EBP22 2.5 mg (5 x 0.5 mg tablets)EXPERIMENTALSingle dose of oral EBP22 2.5 mg (5 x 0.5 mg tablets)
Treatment O EBP11-F4 2.5 mgEXPERIMENTALSingle dose of oral EBP11-F4 2.5 mg
Treatment P EBP11-F2 1.5 mgEXPERIMENTALSingle dose of oral EBP11-F2 1.5 mg
Treatment Q EBP11-F4 2.5 mgEXPERIMENTALSingle dose of oral EBP11-F4 2.5 mg
Treatment R EBP11-F5 3.0 mgEXPERIMENTALSingle dose of oral EBP11-F5 3.0 mg
Treatment S EBP11-F1 1.0 mgEXPERIMENTALSingle dose of oral EBP11-F1 1.0 mg
Interventions
NameTypeDescription
EBP05DRUGtablets
Placebo of EBP05DRUGtablets
Forteo 0.02 mgDRUGSubcutaneous injection
EBP11DRUGOral tablets
EBP22DRUGOral tablets
EBP11-F2DRUGOral tablets
EBP11-F4DRUGOral tablets
EBP11-F1DRUGOral tablets
EBP11-F5DRUGOral tablets
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Eligibility Criteria
Age Range50 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites4

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 ...

Countries:Israel
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Competitive Landscape -Osteoporosis 8 trials
CompanyTickerTrialsLead PhaseDrugs
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
Precision BioSciences, Inc.DTIL1N/AUndisclosed
SI-BONE, Inc.SIBN1 - Undisclosed
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