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Reldesemtiv

Phase 2

Amyotrophic Lateral Sclerosis | Small molecule | Neurology |Cytokinetics, Incorporated|Last Updated: Sep 11, 2020

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 Trials1
Total Enrollment458
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03160898A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)PHASE2 COMPLETED 458 — — Jul 24, 2017Mar 7, 2019Sep 11, 202064 United States, Australia +4
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Study Endpoints
Primary Endpoints
Change From Baseline to Week 12 in the Percent Predicted Slow Vital Capacity (SVC)
Baseline to Week 12

Slow vital capacity was measured using a spirometer (in units of liters). Following 3 to 5 breaths at rest, patients were instructed to take as deep an inspiration as possible followed by a maximum exhalation (blowing out all the air in their lungs). Values obtained were converted to percent predicted values using the Global Lung Initiative equation (ie, the test result as a percent of predicted values for patients of similar demographic and baseline characteristics \[eg, height, age, sex\]).

Secondary Endpoints
Change From Baseline to Week 12 in the ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score
Baseline to Week 12
Slope of Muscle Strength Mega-score From Baseline to Week 12
Baseline to Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Reldesemtiv 150 mg twice dailyEXPERIMENTALPatients in this arm took 1 reldesemtiv 150 mg oral tablet and 2 matching placebo tablets every 12 hours for 12 weeks.
Reldesemtiv 300 mg twice dailyEXPERIMENTALPatients in this arm took 2 reldesemtiv 150 mg oral tablets and 1 matching placebo tablet every 12 hours for 12 weeks.
Reldesemtiv 450 mg twice dailyEXPERIMENTALPatients in this arm took 3 reldesemtiv 150 mg oral tablets every 12 hours for 12 weeks.
PlaceboPLACEBO_COMPARATORPatients in this arm took 3 placebo oral tablets every 12 hours for 12 weeks.
Interventions
NameTypeDescription
ReldesemtivDRUGOral tablet
PlaceboDRUGOral tablet
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites64

Inclusion Criteria: * Diagnosis of familial or sporadic ALS ≤ 24 months prior to screening * Upright Slow Vital Capacity (SVC) ≥ 60% of predicted for age, height and sex at screening * Able to swallow tablets * A caregiver (if one is needed) * Able to perform reproducible pulmonary function tests *...

Countries:United StatesAustraliaCanadaIrelandNetherlandsSpain
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