• BioMarin Pharmaceutical Inc., of Novato, Calif., said updated data from its Phase I/II extension study of GALNS (N-acetylgalactosamine 6-sulfatase), showed no new or consistent patterns of clinically meaningful or treatment-limiting adverse events in patients with mucopolysaccharidosis Type IVA. Measures of the six-minute walk distance, three-minute stair climb and pulmonary function all generally improved and were sustained for at least two years, and for the patient group with a baseline six-minute walk distance of < 325 meters, mean walk distance remained consistently improved for the entire period of observation. Overall, BioMarin said the additional data supported the use the six-minute walk test as the primary endpoint for the ongoing Phase III study. (See BioWorld Today, Feb. 2, 2011.)

• Merck KGaA, of Darmstadt, Germany, said its Merck Serono division and partner Newron Pharmaceuticals SpA, of Milan, Italy, completed patient enrollment in the SETTLE1 Phase III study of safinamide, an alpha-aminoamide, as an adjunctive therapy to a stable dose of levodopa in Parkinson's disease patients. A total of 549 patients with mid- to late-stage disease with motor fluctuations were recruited for the six-month study, which is measuring the change in daily "on" time, as assessed by the recordings of diary cards maintained by patients, from baseline to week 24 as the primary endpoint.