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ALX1-11

Phase 3

Osteoporosis | Small molecule | Endocrine |Takeda Pharmaceutical Company Limited|Last Updated: May 17, 2021

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment4,523
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00172120Open Label ExtensionPHASE3 COMPLETED 91 — — Jan 10, 2005Oct 27, 2006May 17, 202112 United States, Argentina
NCT00172133Open Label Extension Study of PREOSPHASE3 COMPLETED 1,683 — — Oct 16, 2001Apr 13, 2005May 17, 2021132 United States, Argentina +6
NCT00172081TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal OsteoporosisPHASE3 COMPLETED 2,532 — — Apr 27, 2000Nov 7, 2003May 14, 2021174 United States, Argentina +7
NCT00172107A Study to Assess the Safety and Efficacy of 3 Doses of ALX1-11 (50, 75, and 100µg) in the Treatment of Postmenopausal OsteoporosisPHASE2 COMPLETED 217 — — May 18, 1995Mar 24, 1997May 17, 202119 United States, Canada
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Study Endpoints
Primary Endpoints
The primary objective of this study is to evaluate the safety of continued once-daily dosing with 100 mg ALX1-11 in postmenopausal osteoporotic women who participated in TOP and OLES clinical trials.
Throughout the study period of approximately 18 months.
To evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1-11-93001 (TOP).
24 months of treatment
Compare effects of 18 months of treatment with ALX1-11/placebo on the incidence of new and/or worsened thoracic and lumbar vertebral fractures in postmenopausal women with osteoporosis receiving calcium and vitamin D3 supplements
At Month 18
Efficacy was assessed as percent change from baseline in BMD, BMC, and BMA at the lumbar spine, total hip, femoral neck and whole body (excluding the head) using DXA.
12 months of treatment
Secondary Endpoints
The secondary objective is to evaluate the continued efficacy of once-daily treatment with ALX1-11 for maintaining increases in bone mineral density (BMD).
Throughout the study period of approximately 18 months.
To evaluate the continued efficacy of once-daily treatment with ALX1-11 for maintaining increases in BMD and other measures of bone quality and strength.
24 months of treatment
Incidences of vertebral fractures at Month 12; hip and wrist fractures; and other clinical fractures.
At Month 12
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAll patients entering the study will receive 100mcg daily for up to 6 months, making their total exposure 24 months
placeboPLACEBO_COMPARATORDaily subcutaneous injection into thigh or abdomen with 700 mg Calcium and 400 IU Vitamin D daily
PTH(1-84) 100 mcgEXPERIMENTALSubcutaneous injection of PTH(1-84) with 700 mg Calcium and 400 IU Vitamin D daily
2EXPERIMENTAL50 mcg PTH(1-84)
3EXPERIMENTAL75mcg PTH(1-84)
4EXPERIMENTAL100 mcg PTH(1-84)
Interventions
NameTypeDescription
ALX1-11DRUG -
ALX1-11 (drug)DRUG100 mcg PTH(1-84) injected subcutaneously daily in either the thrigh and abdomen.
placeboDRUGDaily subcutaneous injection with placebo
ALX1-11 50 mcgDRUGPTH(1-84) 50 mcg for subcutaneous injection into thigh or abdomen
ALX1-11 75mcgDRUGPTH(1-84)75 mcg for subcutaneous injection
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Eligibility Criteria
Age Range45 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Received placebo in TOP * Completed 18 months of daily treatment with ALX1-11 in OLES * Received their last dose of ALX1-11 in OLES within 3 months (90 days) of dosing in this study * Have the ability to continue to self-administer, or have a designee administer, a daily injec...

Countries:United StatesArgentinaBrazilCanadaIsraelMexicoRomaniaRussiaBulgaria
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Competitive Landscape -Osteoporosis 8 trials
CompanyTickerTrialsLead PhaseDrugs
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Precision BioSciences, Inc.DTIL1NAUndisclosed
SI-BONE, Inc.SIBN1 — Undisclosed
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