BioMarin (BMRN) Announces Completion of Enrollment for Phase 3 Study on GALNS
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BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that enrollment is complete for the pivotal Phase 3 trial for N-acetylgalactosamine 6-sulfatase (GALNS or BMN-110), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), also called Morquio A Syndrome. The company expects to report results in the fourth quarter of 2012.
The Phase 3 trial is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of GALNS in patients with MPS IVA. The study is exploring doses of two mg/kg/week and two mg/kg/every other week for a treatment period of 24 weeks. The primary endpoint is the six-minute walk test, and the secondary endpoints are the three-minute stair climb test and urine keratan sulfate concentration.
The Phase 3 trial is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of GALNS in patients with MPS IVA. The study is exploring doses of two mg/kg/week and two mg/kg/every other week for a treatment period of 24 weeks. The primary endpoint is the six-minute walk test, and the secondary endpoints are the three-minute stair climb test and urine keratan sulfate concentration.
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