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PIPE-307

Phase 1

Multiple Sclerosis | Small molecule | Neurology |Contineum Therapeutics, Inc.|Last Updated: Oct 5, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

PIPE-307 · 2 trials · 1 indication

Phase 1 2
NCT04941781PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy VolunteersMultiple Sclerosis
COMPLETED6 Analytics
NCT04725175Phase I Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of of PIPE-307 and Food Effect in Healthy VolunteersMultiple Sclerosis
COMPLETED70 Analytics
PHASE1COMPLETED
PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers
Multiple SclerosisUnlock trial analytics
PHASE1COMPLETED
Phase I Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of of PIPE-307 and Food Effect in Healthy Volunteers
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Safety: Cardiac repolarization using Fridericia-corrected QT interval (QTcF)
From baseline to 14 days post dose for SAD cohorts and 21 days post last dose for MAD cohorts
Pharmacokinetics (PK): Blood concentration levels of PIPE-307
From baseline to 14 days post dose for SAD cohorts and 21 days post last dose for MAD cohorts
PK: Urine concentration levels of PIPE-307
From baseline on day 1 through day 2 for SAD cohorts, and from baseline on day 1 though day 7 for the MAD cohorts
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
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 Range25 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Criteria: * Normotensive male or female volunteers between 25-65 years old * Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine Key Exclusion Criteria: * Clinically relevant abnormal findings at the screening asse...

Countries:United KingdomAustralia
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Frequently asked questions about PIPE-307

What is PIPE-307 used for in Multiple Sclerosis?

PIPE-307 is an investigational small molecule being developed for Multiple Sclerosis. It is currently in Phase 1 clinical development, with studies conducted in healthy volunteers to evaluate safety, tolerability, and receptor occupancy. PIPE-307 is not yet approved and remains under investigation for this condition.

What does PIPE-307 target?

PIPE-307 targets the Muscarinic Type 1 Receptor (M1AChR). A Phase 1 PET study was conducted to determine the relationship between plasma concentrations and M1AChR occupancy of PIPE-307 in healthy volunteers, indicating that the drug is designed to interact with this receptor.

Who makes PIPE-307?

PIPE-307 is being developed by Contineum Therapeutics, Inc., a biopharmaceutical company traded under the ticker CTNM. The company is conducting Phase 1 clinical trials for this investigational drug in Multiple Sclerosis.

What phase is PIPE-307 in?

PIPE-307 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is PIPE-307 in?

PIPE-307 has two completed Phase 1 trials. NCT04725175 evaluated safety and tolerability of escalating single and multiple doses and food effect in 70 healthy volunteers in Australia. NCT04941781 was a PET study in 6 healthy volunteers in the United Kingdom to determine M1AChR occupancy.

Is PIPE-307 the same as other names?

PIPE-307 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information.