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MTX-463

Phase 1

Healthy | Monoclonal antibody | Other |Icon Plc|Last Updated: Jan 17, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06401213A First-in-Human Safety Trial of MTX-463PHASE1 COMPLETED 56 — — Apr 15, 2024Nov 15, 2024Jan 17, 20251 United States
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Study Endpoints
Primary Endpoints
Incidence of Treatment-Related Adverse Events in healthy volunteers
Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)

Clinical Safety Labs are collected, and Adverse Events are assessed in both inpatient and outpatient clinic visits

MTX-463 PK by dose will be evaluated for Cmax, as feasible
Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)

Blood serum samples will be collected at protocol-specified timepoints throughout the study

Serum sample results will be summarized for presence of Anti-Drug Antibodies during the SAD and MAD portions of the study.
Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)

Blood serum samples will be collected at protocol-specified timepoints throughout the study to assess for the presence and titer (if applicable) of Anti-Drug Antibodies.

MTX-463 PK by dose will be evaluated for AUC0-t, as feasible.
Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)

Blood serum samples will be collected at protocol-specified timepoints throughout the study

MTX-463 PK by dose will be evaluated for AUC0-tau (MAD only), as feasible
Through Day 82 (MAD Cohort)

Blood serum samples will be collected at protocol-specified timepoints throughout the study

MTX-463 PK by dose will be evaluated for AUC0-∞, as feasible
Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)

Blood serum samples will be collected at protocol-specified timepoints throughout the study

Secondary Endpoints
Blood serum samples will be collected to determine the level of WISP1 engagement of MTX-463 in healthy adult participants
Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)
To assess the effect of baseline body mass index (BMI) on total and free WISP1 levels
Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
MTX-463EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
MTX-463BIOLOGICALMTX-463 is an immunoglobin G1 (IgG1) monoclonal antibody directed against WNT-inducible signaling pathway protein 1 (WISP1). WISP1 (aka CCN-4) is a matricellular protein that appears to be upregulated locally in response to certain chronic diseases and malignancies.
PlaceboOTHERMatching Placebo-- Normal Saline
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * All genders, ages 18 to 60 years, inclusive * Willing and able to complete all protocol-required study visits and procedures * Non-smoker and has not used nicotine- or cotinine-containing products (including tobacco, nicotine gum, patches, and e-cigarettes) for at least 90...

Countries:United States
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