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LP-08

Phase 2

Interstitial Cystitis | Small molecule | Other |Lipella Pharmaceuticals Inc.|Last Updated: Nov 1, 2018

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 Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01393223Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder SyndromePHASE2 COMPLETED 21Jul 21, 2015Jun 14, 2018Nov 1, 20181 United States
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Study Endpoints
Primary Endpoints
Safety of Intravesical LP08: number/severity of adverse events
Up to 31 weeks following treatment

The number/severity of adverse events throughout the study

Secondary Endpoints
Efficacy Voids Per Day (VPD)
2, 4, 8, 16, 24 weeks following treatment
Efficacy Global Response Assessment (GRA)
4, 8, 16, 24 weeks following treatment
Efficacy Symptom
2, 4, 8, 16, 24 weeks following treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LP-08 80mgACTIVE_COMPARATOR4 weekly intravesical administration of LP-08 80mg
LP-08 20mgACTIVE_COMPARATOR4 weekly intravesical administration of LP-08 20mg
Normal SalinePLACEBO_COMPARATORFour weekly normal saline intravesical administration
Interventions
NameTypeDescription
LP-08 80mgDRUGIntravesical instillation of 80mg LP08
Normal salineDRUGIntravesical instillation of normal saline
LP-08 20mgDRUGIntravesical instillation of 20mg LP08
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: A patient is deemed suitable for inclusion in the study if the patient meets the following criteria: 1. Male or female at least 18 years of age 2. IC/BPS diagnosed by a health care provider based the following criteria: Complaint of suprapubic pain related to bladder fillin...

Countries:United States
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