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BMN 307

Phase 1

Phenylketonuria (PKU) | Small molecule | Rare Disease |BioMarin Pharmaceutical Inc.|Last Updated: Dec 12, 2024

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04480567AAV Gene Therapy Study for Subjects with PKUPHASE1 ACTIVE NOT_RECRUITING 100Sep 24, 2020Dec 1, 2027Dec 12, 20243 United States, United Kingdom
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Study Endpoints
Primary Endpoints
Change from baseline in mean Plasma Phe levels
baseline, week 12
Secondary Endpoints
Change from baseline in mean Plasma Phe levels
baseline, week 96
Change from baseline in dietary protein intake from intact food
baseline, week 96
Number of participants with treatment-emergent adverse event
At 5 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose 1 of BMN 307EXPERIMENTAL -
Dose 2 of BMN 307EXPERIMENTAL -
Dose 3 of BMN 307EXPERIMENTAL -
Interventions
NameTypeDescription
BMN 307DRUGAAV Gene Therapy Infusion
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Eligibility Criteria
Age Range15 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Male and female subjects with diagnosis of PKU which is a condition characterized by PAH deficiency * Ability and willingness to maintain dietary protein intake consistent with baseline intake * Willingness to abstain from hepatotoxic substances post-BMN 307 administration * W...

Countries:United StatesUnited Kingdom
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Competitive Landscape -Phenylketonuria 12 trials
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04480567primaryCompletionDate: changed
LOWMay 24, 2026NCT04480567studyFirstPostDate: changed