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BMN 110 Weekly

Phase 3

MPS IV A | Small molecule | Rare Disease |BioMarin Pharmaceutical Inc.|Last Updated: Jul 7, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment177

FDA Designations

No designations recorded

Clinical trial landscape

BMN 110 Weekly · 1 trial · 1 indication

Phase 3 1
NCT01275066A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)MPS IV A
COMPLETED177 Analytics
PHASE3COMPLETED
A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)
MPS IV AUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Endurance as Measured by the 6-minute Walk Test
Baseline to Week 24

Secondary Endpoints

Change From Baseline in Endurance as Measured by the 3-minute Stair Climb Test
Baseline to Week 24
Percent Change From Baseline in Urine Keratan Sulfate Normalized for Urine Creatinine
Baseline to Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
BMN 110 WeeklyEXPERIMENTAL -
BMN 110 Every Other WeekEXPERIMENTAL -

Interventions

NameTypeDescription
BMN 110 WeeklyDRUGBMN 110 Weekly: Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
PlaceboDRUGIntravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
BMN 110 Every Other WeekDRUGBMN 110 Every Other Week: Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
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Eligibility Criteria

Age Range5 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * At least 5 years of age. * Documented clinical diagnosis of MPS IVA based on clinical signs and symptoms of MPS IVA and documented reduced fibroblast or leukocyte GALNS enzyme activity or genetic testing confirming diagnosis of MPS IVA. * Willing and able to provide written, s...

Countries:United StatesArgentinaBrazilCanadaColombiaDenmarkFranceGermanyItalyJapanNetherlandsPortugalQatarSaudi ArabiaSouth KoreaTaiwanUnited Kingdom
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Frequently asked questions about BMN 110 Weekly

What is BMN 110 Weekly used for in MPS IV A?

BMN 110 Weekly is an investigational small molecule being studied for the treatment of Mucopolysaccharidosis IV A (MPS IV A), also known as Morquio A syndrome. It is developed by BioMarin Pharmaceutical Inc. (BMRN) and is currently in Phase 3 clinical development for this rare disease indication.

What does BMN 110 Weekly target?

BMN 110 Weekly is a small molecule therapy. The specific molecular target of BMN 110 Weekly is not disclosed in the available clinical trial information. The drug is being evaluated for its efficacy and safety in patients with Mucopolysaccharidosis IV A (Morquio A syndrome).

Who makes BMN 110 Weekly?

BMN 110 Weekly is developed by BioMarin Pharmaceutical Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BMRN. BioMarin is conducting Phase 3 clinical trials to evaluate the drug for the treatment of Mucopolysaccharidosis IV A (Morquio A syndrome).

What phase is BMN 110 Weekly in?

BMN 110 Weekly is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, including a double-blind, placebo-controlled study and a long-term extension study, both in patients with MPS IV A.

What clinical trials is BMN 110 Weekly in?

BMN 110 Weekly has been studied in two completed Phase 3 trials. The first, NCT01275066, was a double-blind, placebo-controlled study in 177 patients with MPS IV A. The second, NCT01415427, was a long-term extension study enrolling 173 patients. Both trials included patients aged 5 years and older across multiple countries.

Is BMN 110 Weekly the same as elosulfase alfa?

BMN 110 Weekly is the investigational name for the drug also known as elosulfase alfa. It is developed by BioMarin Pharmaceutical Inc. for the treatment of Mucopolysaccharidosis IV A (Morquio A syndrome). The drug has been evaluated in Phase 3 clinical trials under the name BMN 110.