Recent Updates
Recently added Catalysts

BMN 331

Phase 1

Hereditary Angioedema | Gene therapy | Immunology |BioMarin Pharmaceutical Inc.|Last Updated: May 16, 2024

Target and mechanism

Molecular targetSERPING1
ModalityGene therapy

Also known as Dose 1 of BMN 331

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

BMN 331 · 1 trial · 2 indications

Phase 1 1
NCT05121376A Gene Therapy Study of BMN 331 in Subjects With Hereditary AngioedemaHereditary Angioedema
ACTIVE NOT_RECRUITING44 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Gene Therapy Study of BMN 331 in Subjects With Hereditary Angioedema
Hereditary AngioedemaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with treatment-emergent adverse events following a single IV administration of BMN 331
At 5 years

Secondary Endpoints

Time-normalized number of investigator-confirmed HAE attacks
At 5 years
Time-normalized number of investigator-confirmed HAE attacks by severity (mild, moderate, severe)
At 5 years
Time-normalized use of HAE-specific medication
At 5 years
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMN 331EXPERIMENTALAAV Gene Therapy Infusion

Interventions

NameTypeDescription
Dose 1 of BMN 331GENETICBMN 331 AAV Gene Therapy
Dose 2 of BMN 331GENETICBMN 331 AAV Gene Therapy
Dose 3 of BMN 331GENETICBMN 331 AAV Gene Therapy
Dose 4 of BMN 331GENETICBMN 331 AAV Gene Therapy
Dose 5 of BMN 331GENETICBMN 331 AAV Gene Therapy
Dose 6 of BMN 331GENETICBMN 331 AAV Gene Therapy
Dose 7 of BMN 331GENETICBMN 331 AAV Gene Therapy
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: 1. Female or male adults ( ≥ 18 years old) 2. Part A only: Confirmed diagnosis of Type I HAE due to C1-INH deficiency confirmed by genotyping of the SERPING1 gene Part B only: Confirmed diagnosis of Type I or II HAE due to C1-INH deficiency confirmed by genotyping of the SERPING...

Countries:United StatesAustraliaSpain
Unlock Eligibility Criteria

Frequently asked questions about BMN 331

What is BMN 331 used for?

BMN 331 is an investigational gene therapy being developed for the treatment of hereditary angioedema (HAE), a genetic condition characterized by recurrent episodes of severe swelling. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing BMN 331?

BMN 331 is being developed by BioMarin Pharmaceutical Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BMRN. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of this gene therapy in patients with hereditary angioedema.

What phase is BMN 331 in?

BMN 331 is currently in Phase 1 clinical development. It is an investigational gene therapy for hereditary angioedema and has not yet received regulatory approval. The ongoing Phase 1 study is active but not recruiting participants, with a planned enrollment of 44 subjects.

What clinical trials is BMN 331 in?

BMN 331 is being studied in a single Phase 1 clinical trial registered as NCT05121376, titled 'A Gene Therapy Study of BMN 331 in Subjects With Hereditary Angioedema.' The trial is active but not recruiting, enrolling 44 participants across the United States, Australia, and Spain.

Is BMN 331 a gene therapy?

Yes, BMN 331 is a gene therapy being developed by BioMarin Pharmaceutical Inc. for the treatment of hereditary angioedema. It is currently in Phase 1 clinical trials, and its mechanism of action involves delivering genetic material to address the underlying cause of the condition.