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January 3, 2013
07:41 EDTZGNXZogenix reports positive results from Relday Phase 1 clinical trial
Zogenix announced positive single-dose pharmacokinetic, or PK, results from the Phase 1 clinical trial of Relday, an investigational candidate of a proprietary, once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia. Adverse events in the Phase 1 trial in patients diagnosed with schizophrenia were generally mild to moderate and consistent with other risperidone products. Based on the favorable safety and PK profile demonstrated with the 25 mg and 50 mg once-monthly doses tested in the Phase 1 trial, Zogenix has extended the current study to include a 100 mg dose of the same formulation. The addition of this dose arm to the study will enable evaluation of dose proportionality across the full dose range that would be anticipated to be used in clinical practice. Positive results from this study extension would better position Zogenix to begin a multi-dose clinical trial, which would provide the required steady-state PK and safety data prior to initiating Phase 3 development studies. Zogenix expects to complete the extension of the Phase 1 clinical trial during Q2.
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May 27, 2015
08:44 EDTZGNXZogenix announces new efficacy data from study of low-dose fenfluramine
Zogenix announced new data demonstrating sustained efficacy and tolerability for patients treated with low-dose fenfluramine as an adjunctive therapy for Dravet syndrome. The data was authored by world-renown experts in the field of Dravet syndrome, Berten Ceulemans, M.D., Ph.D. and Lieven Lagae, M.D., Ph.D., from the Universities of Antwerp and Leuven in Belgium, and was presented at the European Paediatric Neurology Society meeting taking place this week in Vienna, Austria. Zogenix intends to initiate Phase 3 clinical studies for ZX008, the company's investigational proprietary pediatric formulation of low-dose fenfluramine, during the second half of 2015. ZX008 is designated as an orphan drug in both the U.S. and Europe for the treatment of Dravet syndrome. The results presented are from the latest 5-year follow-up period in a group of Dravet syndrome patients being treated with low-dose fenfluramine. This analysis, which includes ten patients from the original study group and two patients who began treatment in 2011, demonstrated that during any given year of the follow-up period, at least 80% of patients achieved a greater than or equal to 75% reduction in the frequency of seizures. In addition, three patients were seizure-free for all 5 years and five patients were seizure-free for 2 to 4 years. The use of low-dose fenfluramine in this group of patients was shown to be generally well tolerated, with the most common adverse events being transient loss of appetite and fatigue/somnolence. No clinically meaningful cardiac adverse events were noted. No patient discontinued treatment due to adverse events. In addition, a recently published translational research study to elucidate fenfluramine's mechanism of action in Dravet syndrome demonstrated the ability of fenfluramine to significantly reduce locomotion and eliminate epileptiform EEG activity in a gene knockdown zebrafish model of Dravet syndrome. These data support the clinical results obtained in the Belgium cohort of patients.

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