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ARO-MMP7

Phase 1

Idiopathic Pulmonary Fibrosis | Small molecule | Respiratory |Arrowhead Pharmaceuticals, Inc.|Last Updated: Oct 15, 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 Enrollment105
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05537025Study of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary FibrosisPHASE1 COMPLETED 105 — — Jan 30, 2023Sep 5, 2025Oct 15, 202519 Denmark, Italy +4
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over Time
From first dose of study drug through the end of study (EOS; up to 85 days, or until sputum MMP7 protein concentration is ≥ 70% of the baseline value, whichever is later)
Secondary Endpoints
Change From Baseline Over Time in Forced Expiratory Volume (FEV1)
Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is ≥ 70% of the baseline value, whichever is later)
Change From Baseline Over Time in Forced Vital Capacity (FVC)
Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is ≥ 70% of the baseline value, whichever is later)
Change From Baseline Over Time in Diffusing Capacity for Carbon Monoxide (DLCO)
Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is ≥ 70% of the baseline value, whichever is later)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARO-MMP7EXPERIMENTALsingle or multiple doses of ARO-MMP7 by inhalation of nebulized solution
PlaceboPLACEBO_COMPARATORsingle or multiple doses of placebo by inhalation of nebulized solution
Interventions
NameTypeDescription
ARO-MMP7 Inhalation SolutionDRUGARO-MMP7 by inhalation of nebulized solution
PlaceboDRUGCalculated volume of normal saline (0.9% NaCl) to match active treatment by inhalation of nebulized solution
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites19

Inclusion Criteria (NHVs): * Normal pulmonary function tests at Screening * Normal electrocardiogram (ECG) at Screening * Non-smoking * Female participants cannot be pregnant or lactating * Male and female participants of childbearing potential must agree to use highly effective contraception and m...

Countries:DenmarkItalyNew ZealandSouth KoreaSpainUnited Kingdom
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Competitive Landscape -Idiopathic Pulmonary Fibrosis 22 trials
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Cumberland Pharmaceuticals Inc.CPIX1PHASE2Ifetroban
Avalyn Pharma IncAVLN3PHASE2AP02, AP01
MannKind CorporationMNKD1PHASE1MNKD-201
Trevi Therapeutics, Inc.TRVI1PHASE1NAL
AgomAb Therapeutics NV ADRAGMB1PHASE1AGMB-447
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