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TVB-009

Phase 3

Osteoporosis, Postmenopausal | Small molecule | Endocrine |Teva Pharmaceutical Industries Limited|Last Updated: Apr 18, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment332
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04729621A Study to Test if TVB-009P is Effective in Relieving Postmenopausal OsteoporosisPHASE3 COMPLETED 332 — — Mar 22, 2021Jun 19, 2023Apr 18, 202478 United States, Bulgaria +8
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Study Endpoints
Primary Endpoints
Percent Change From Baseline in LS-BMD at Week 52
Baseline and week 52

Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52

Secondary Endpoints
Percent Change From Baseline in sCTX-1 at Week 26
Baseline and week 26
Percent Change From Baseline in LS-BMD at Week 26
Baseline and week 26
Percent Change From Baseline in Femoral Neck BMD at Week 26
Baseline, week 26
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TVB-009 main treatment periodEXPERIMENTALTVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
PROLIA main treatment periodACTIVE_COMPARATORProlia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
TVB-009 main / TVB-009 transition periodEXPERIMENTALTVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period
PROLIA main / PROLIA transition periodACTIVE_COMPARATORProlia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
PROLIA main / TVB-009 transition periodEXPERIMENTALTVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
Interventions
NameTypeDescription
TVB-009COMBINATION_PRODUCTTVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Prolia®COMBINATION_PRODUCTDenosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
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Eligibility Criteria
Age Range60 Years — 90 Years
SexFEMALE
Healthy VolunteersNo
Study Sites78

Inclusion Criteria: * Postmenopausal womeen (≥60 and ≤90 years) with a diagnosis of osteoporosis * Body weight ≥50 kg and ≤90 kg * Bone Mineral Density (BMD) measurement T score of less than -2.5 but not less than -4.0 by dual-energy X-ray absorptiometry (DXA) at the lumbar spine at screening * At ...

Countries:United StatesBulgariaCzechiaGeorgiaGermanyHungaryPolandRussiaSlovakiaUkraine
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