Recent Updates
Recently added Catalysts

PIPE-791

Phase 1

Multiple Sclerosis | Small molecule | Immunology |Contineum Therapeutics, Inc.|Last Updated: Feb 14, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05983939Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy VolunteersPHASE1 COMPLETED 56 — — Jun 26, 2023Feb 1, 2024Feb 14, 20241 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety: Treatment-Emergent Adverse Events (TEAE)
Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts

Number of participants with TEAEs

Secondary Endpoints
Safety: Cardiac repolarization using Fridericia-corrected QT interval (QTcF)
Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts
Pharmacokinetics (PK): Blood concentration levels of PIPE-791
Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts
Pharmacokinetics: Urine concentration levels of PIPE-791
Baseline on day 1 through day 2 for SAD cohorts and from baseline on day 1 through day 7 for MAD cohorts
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PIPE-791EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PIPE-791DRUGSingle and multiple ascending oral doses of PIPE-791 tablets.
PlaceboDRUGSingle and multiple ascending oral doses of matching placebo tablets.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female between 18 and 55 years of age (inclusive) at the time of signing informed consent. * Male or female subjects with reproductive potential agree to comply with protocol-approved double barrier contraceptive method 30 days prior to the first dose and up to 90 days...

Countries:United States
Unlock Eligibility Criteria
Competitive Landscape -Multiple Sclerosis 98 trials
CompanyTickerTrialsLead PhaseDrugs
Sanofi SA Sponsored ADRSNY6PHASE3Frexalimab, MRI contrast-enhancing agents, Tolebrutinib, Teriflunomide, Cholestyramine
Novartis AG Sponsored ADRNVS23PHASE3Remibrutinib, Teriflunomide, Fingolimod, Ofatumumab, Siponimod
Biogen Inc.BIIB6PHASE3BIIB017, Interferon beta type 1a, Diroximel, Dimethyl, Fingolimod
Bristol-Myers Squibb CompanyBMY8PHASE3Ozanimod, Fingolimod, BMS-986368, CC-97540, Fludarabine
TG Therapeutics, Inc.TGTX8PHASE3Ublituximab, Fingolimod
Zenas BioPharma, Inc.ZBIO3PHASE3Orelabrutinib, Obexelimab
Immunic, Inc.IMUX3PHASE3IMU-838
Amgen Inc.AMGN1PHASE3Ocrelizumab, ABP 692
Eli Lilly and CompanyLLY1PHASE2LY3541860
Moderna, Inc.MRNA1PHASE2mRNA-1195
Kyverna Therapeutics, Inc.KYTX3PHASE2KYV-101, Standard lymphodepletion regimen, Anti-CD20 mAB, KYV-101 - 0.33 ×10^8 cells, KYV-101 - 1 ×10^8 cells
Tiziana Life Sciences Ltd.TLSA2PHASE2Foralumab TZLS-401 100 µg, Foralumab
Supernus Pharmaceuticals, Inc.SUPN1PHASE2Phase 2; Low Dose MYOBLOC, Phase 3; MYOBLOC
AstraZeneca PLCAZN1PHASE1AZD0120 - Regimen 1, AZD0120 - Regimen 2
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Cabaletta Bio, Inc.CABA1PHASE1CABA-201
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE1Obecabtagene autoleucel
TScan Therapeutics, Inc.TCRX1 — Undisclosed
Merck & Co., Inc.MRK1 — Mavenclad
Solana Company Class AHSDT1 — Undisclosed
Unlock Competitive Intelligence