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PIPE-307

Phase 2

Relapsing Remitting Multiple Sclerosis | Small molecule | Neurology |Contineum Therapeutics, Inc.|Trials Updated: Sep 25, 2026

PIPE-307 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Jan 2021

PIPE-307 target and mechanism

Molecular targetM1 receptor
Target classReceptor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment258

FDA Designations

No designations recorded

PIPE-307 clinical trials

PIPE-307 · 3 trials · 2 indications

Phase 2 1Phase 1 2
NCT06083753Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing Remitting Multiple Sclerosis
COMPLETED182 Analytics
PHASE2COMPLETED
Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis
Relapsing Remitting Multiple SclerosisUnlock trial analytics

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)
M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours
24 hours
Safety: Treatment-Emergent Adverse Events (TEAE)
From baseline to 7 days post dosing for SAD cohorts and 21 days post dosing for MAD cohorts

Number of participants with TEAEs

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 -
PIPE-307EXPERIMENTALSubjects will receive an oral dose of PIPE-307 and 3 intravenous injections of \[11C\] PIPE- 307.

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
PIPE-307DRUGEach dose cohort will receive a single oral dose of PIPE-307. Doses to be tested in subsequent cohorts will be determined by the analysis of the exposure from PK data and the PET scans with \[11C\] PIPE-307. Subjects will receive an intravenous dose of the radioligand \[11C\] PIPE-307 prior to PET imaging.
Placebo oral tabletDRUGSingle and multiple ascending oral doses of matching Placebo tablets
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Eligibility Criteria

Age Range18 Years to 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 StatesUnited KingdomAustralia
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Recent Changes (Last 90 Days)

MEDIUMAug 15, 2026NCT06083753TRIAL_REMOVED: changed
MEDIUMAug 15, 2026NCT06083753TRIAL_REMOVED: changed
MEDIUMAug 15, 2026NCT06083753TRIAL_REMOVED: changed

Frequently asked questions about PIPE-307

What is PIPE-307 used for?

PIPE-307 is an investigational small molecule being developed for the treatment of multiple sclerosis, including relapsing remitting multiple sclerosis. It is designed as a selective muscarinic M1 receptor agonist with the goal of promoting remyelination in patients with demyelinating diseases such as MS.

What does PIPE-307 target?

PIPE-307 targets the muscarinic M1 receptor, a G protein-coupled receptor. By selectively activating this receptor, PIPE-307 is intended to stimulate oligodendrocyte precursor cells to differentiate and remyelinate damaged axons, offering a potential approach to restoring neurological function in multiple sclerosis.

Who is developing PIPE-307?

PIPE-307 is being developed by Contineum Therapeutics, Inc., a clinical-stage biopharmaceutical company. Contineum Therapeutics trades on the Nasdaq under the ticker symbol CTNM. The company focuses on discovering and developing novel therapies for neuroscience and immunology indications.

What phase is PIPE-307 in?

PIPE-307 is in Phase 1 clinical development, with completed Phase 1 trials in healthy volunteers. A Phase 2 trial in relapsing remitting multiple sclerosis has also been completed. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is PIPE-307 in?

PIPE-307 has been evaluated in three completed clinical trials. These include a Phase 2 study in relapsing remitting multiple sclerosis (NCT06083753), a Phase 1 PET study in healthy volunteers (NCT04941781), and a Phase 1 single and multiple ascending dose study with food effect assessment (NCT04725175).

Is PIPE-307 the same as PIPE-307 Dose A?

Yes, PIPE-307 Dose A is an alternative name for PIPE-307. Both refer to the same investigational small molecule developed by Contineum Therapeutics for multiple sclerosis. The dose designation may be used in certain study contexts, but the underlying drug candidate is identical.