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ETX-018810

Phase 2

Lumbosacral Radiculopathy | Small molecule | Other |Climb Bio, Inc.|Last Updated: Nov 7, 2023

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment149
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04778592Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular PainPHASE2 COMPLETED 149 — — Jan 19, 2021May 25, 2022Nov 7, 202324 United States
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Study Endpoints
Primary Endpoints
Change From Baseline to Week 4 in the Weekly Average of the Daily Pain Score as Derived From the Subject's Responses on the Pain Intensity Numerical Rating Scale (PI-NRS)
Baseline to Week 4

Change from baseline in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS), a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).

Secondary Endpoints
Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score
Baseline to Weeks 1, 2, 3 and 4
Number of Subjects With a ≥30% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score
Baseline to Weeks 1, 2, 3 and 4
Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3
Baseline to Weeks 1, 2, and 3
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ETX-018810EXPERIMENTALDrug: ETX-018810 BID for 4 weeks
PlaceboPLACEBO_COMPARATORMatching Placebo BID for 4 weeks
Interventions
NameTypeDescription
ETX-018810DRUGStudy Drug
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * The subject has pain consistent with a diagnosis of chronic lumbosacral radiculopathy due to injury of the lumbosacral nerve root(s) * The subject reports at least moderate pain intensity at screening. * The subject's onset of leg pain due to LSRP is at least 3 months * The su...

Countries:United States
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