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February 4, 2013
16:02 EDTGEVASynageva announces publication of sebelipase alfa study
Synageva BioPharma announced publication of the 12-week Phase I/II extension study data of sebelipase alfa in adults with lysosomal acid lipase deficiency in the online version and an upcoming print edition of Hepatology. Nine adults with LAL Deficiency were enrolled in the Phase I/II trial. After completing the initial portion of the Phase I/II trial, patients were allowed to continue treatment with sebelipase alfa as part of a long-term, open-label extension study. In the extension study, patients received four once-weekly infusions of sebelipase alfa and then transitioned to every other week infusions of sebelipase alfa. Eight of nine patients enrolled in the extension study. Data published in Hepatology were derived from the seven patients who completed the first 12 weeks of dosing in the extension study. Sebelipase alfa was well tolerated throughout the initial 12 weeks of the extension study, the company said.
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December 15, 2014
07:10 EDTGEVASynageva announces active IND for SBC-103
Synageva BioPharma announced that the investigational new drug, or IND, application to the FDA to evaluate SBC-103 as a treatment for mucopolysaccharidosis IIIB, also known as Sanfilippo B syndrome, is active. The company plans to start enrolling patients with MPS IIIB in a Phase 1/2 study investigating intravenous administration of SBC-103 shortly and to report preliminary data from this study in 2015. The company recently completed a study assessing the integrity of the blood-brain barrier and other disease abnormalities in patients with MPS IIIB and plans to report data during the first quarter of 2015. The company is also conducting natural history studies in MPS IIIB. These include a retrospective natural history study of deceased MPS IIIB patients that began in July 2013 and a prospective, longitudinal natural history study in living MPS IIIB patients that began in September 2014.

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