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ETX-018810

Phase 2

Diabetic Peripheral Neuropathic Pain | Small Molecules | Neurology |Climb Bio, Inc.|Trials Updated: Nov 7, 2023

ETX-018810 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Dec 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment316

FDA Designations

No designations recorded

ETX-018810 clinical trials

ETX-018810 · 2 trials · 3 indications

Phase 2 2
NCT04778592Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular PainLumbosacral Radiculopathy
COMPLETED149 Analytics
NCT04688671Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic PainDiabetic Peripheral Neuropathic Pain
COMPLETED167 Analytics
PHASE2COMPLETED
Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
Lumbosacral RadiculopathyUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic PainUnlock trial analytics

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 to 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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Frequently asked questions about ETX-018810

What is ETX-018810?

ETX-018810 is an investigational small molecule developed by Climb Bio, Inc. for neurologic pain conditions. It has been studied in Phase 2 clinical trials for diabetic peripheral neuropathic pain and lumbosacral radiculopathy, also called lumbosacral radicular pain. It is not described as approved and remains in clinical development.

What is ETX-018810 used for?

ETX-018810 has been studied for two pain indications: diabetic peripheral neuropathic pain, a nerve pain condition associated with diabetes, and lumbosacral radiculopathy, which is pain radiating from the lower spine. Both were evaluated in Phase 2 trials conducted in the United States in adults aged 18 years and older.

Who makes ETX-018810?

ETX-018810 is being developed by Climb Bio, Inc., which trades under the ticker CLYM. The company is the sponsor of the clinical program evaluating the small molecule in neurologic pain indications, including diabetic peripheral neuropathic pain and lumbosacral radiculopathy.

What phase is ETX-018810 in?

ETX-018810 is in Phase 2 development. Its two Phase 2 trials, one in diabetic peripheral neuropathic pain and one in lumbosacral radicular pain, are both listed as completed. No Phase 3 program is described, so the asset remains an investigational drug rather than an approved therapy.

What clinical trials is ETX-018810 in?

ETX-018810 has been evaluated in two completed Phase 2 trials. NCT04688671 tested it in diabetic peripheral neuropathic pain with 167 participants, and NCT04778592 tested it in lumbosacral radicular pain with 149 participants. Both were randomized, double-blind, placebo-controlled studies conducted in the United States.

How was ETX-018810 studied in its clinical trials?

Both Phase 2 trials of ETX-018810 were randomized, double-blind, and placebo-controlled, enrolling adults aged 18 years and older of any sex in the United States. NCT04688671 enrolled 167 participants with diabetic peripheral neuropathic pain, and NCT04778592 enrolled 149 participants with lumbosacral radicular pain. Both studies are completed.