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PIPE-307 Dose A

Phase 2

Relapsing Remitting Multiple Sclerosis | Small molecule | Immunology |Contineum Therapeutics, Inc.|Last Updated: Oct 23, 2025

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 Enrollment182
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06083753Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple SclerosisPHASE2 COMPLETED 182 — — Nov 6, 2023Aug 4, 2025Oct 23, 202521 United States
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Study Endpoints
Primary Endpoints
Treatment-emergent adverse events (TEAE)
From baseline to week 26 (end of treatment period)

Number of participants with TEAEs

Change in binocular 2.5% low contrast letter acuity (LCLA)
From baseline to week 26 (end-of-study)
Secondary Endpoints
Percentage of subjects with >/=5-letter gain in binocular 2.5% LCLA
From baseline to week 26
Change in monocular 2.5% LCLA
From baseline to week 26
Number of subjects with at least a 15% change in disability with the Timed 25-Foot Walk Test (T25WT)
From baseline to week 26
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PIPE-307 Dose AEXPERIMENTAL -
PIPE-307 Dose BEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PIPE-307 Dose ADRUGSubjects will receive daily oral doses of PIPE-307
PIPE-307 Dose BDRUGSubjects will receive daily oral doses of PIPE-307
PlaceboDRUGSubjects will receive daily oral matching dose of Placebo
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Subject is fluent in English. * Male or female 18 to 50 years of age, inclusive, at the first Screening visit. * A diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the 2017 Revised McDonald Criteria. * Expanded Disability Status Scale (EDSS) and retinal ...

Countries:United States
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