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ISIS CRP Rx

Phase 2

Paroxysmal Atrial Fibrillation | Small molecule | Cardiovascular |Ionis Pharmaceuticals, Inc.|Last Updated: Aug 26, 2015

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-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01710852Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial FibrillationPHASE2 COMPLETED 7Oct 1, 2012Apr 1, 2014Aug 26, 20151 United Kingdom
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Study Endpoints
Primary Endpoints
AF burden reduction
113 Days

Burden measured as percentage of time spent in AF as derived from continuous pacemaker monitoring

Secondary Endpoints
To assess the effect of ISIS CRP Rx on the:
113 Days
To assess the effect of ISIS CRP Rx on ventricular rate during sinus rhythm
113 Days
To assess the effect of ISIS CRP Rx on measures of Quality of Life
113 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTALISIS CRP Rx followed by Placebo
Group BEXPERIMENTALPlacebo followed by ISIS CRP Rx
Interventions
NameTypeDescription
ISIS CRP RxDRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male of female; age over 18 years * Dual chamber permanent pacemaker implanted * Confirmed diagnosis of paroxysmal atrial fibrillation with an AF burden of 1 to 50%, as derived from pacemaker diagnostic algorithms * Able to have pacemaker antiarrhythmic algorithms turned off f...

Countries:United Kingdom
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