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AOC 1044

Phase 2

DMD | Small molecule | Neurology |Atrium Therapeutics, Inc.|Last Updated: May 14, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06244082Ph2 Open-label Study of AOC 1044 in Duchenne Muscular Dystrophy Participants With Mutations Amenable to Exon44 SkippingPHASE2 ACTIVE NOT_RECRUITING 39Jan 22, 2024Jul 31, 2027May 14, 202510 United States
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Study Endpoints
Primary Endpoints
Incidence of Treatment Emergent Adverse Events (TEAEs)
Through study completion (approximately 2 years)
Secondary Endpoints
Change from baseline in serum creatine kinase concentration at Study Weeks 24, 48, and 102
Through study completion (approximately 2 years)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AOC 1044 Multiple Dose LevelsEXPERIMENTALAOC 1044 will be IV infused every 6 weeks for approximately 2 years.
Interventions
NameTypeDescription
AOC 1044DRUGAOC 1044 will be administered via intravenous (IV) infusion
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Eligibility Criteria
Age Range7 Years — 27 Years
SexMALE
Healthy VolunteersNo
Study Sites10

Key Inclusion Criteria Rollover Participants: * Satisfactorily completed AOC 1044-CS1 (EXPLORE44) as determined by the Investigator and Sponsor * No significant tolerability issues with AOC 1044 De novo Participants: * Aged 7 to 27 years, inclusive, at the time of informed consent * Clinical dia...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06244082primaryCompletionDate: changed
LOWMay 24, 2026NCT06244082studyFirstPostDate: changed