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Zogenix Presents Positive Findings On The Impact Of Treatment With FINTEPLA

Zogenix Inc. (ZGNX) announced results from a post-hoc analysis of its investigational drug, FINTEPLA (ZX008), on caregiver-reported everyday executive function in children and young adults with Dravet syndrome, who participated in the Company's first pivotal Phase 3 clinical trial, Study 1.

In Study 1, of the 119 total patients in the trial, 77 patients, aged 5-18 years, were assessed using the Behavior Rating Inventory of Executive Function (BRIEF®) scale. The BRIEF scale was developed to assess everyday executive function in the home and school environments for children and young adults from 5-18 years of age. The data from Study 1 were mapped to the BRIEF 2 scale, which is a more current, validated version with more stable and sensitive scales for assessing changes related to everyday executive function.

Patients were randomized to one of three treatment groups: FINTEPLA 0.8 mg/kg/day (30 mg maximum daily dose; n=28), FINTEPLA 0.2 mg/kg/day (n=24) or placebo (n=25). Using the BRIEF2 scale, Reliable Change Index scores (RCIs) were calculated to evaluate whether changes from baseline to end of study in individual scores were clinically meaningful or were changes greater than expected due to measurement error, practice effects, and other factors, such as age.

Following 14 weeks of treatment, patients treated with FINTEPLA experienced clinically meaningful improvement on the Behavior Regulation and Emotion Regulation Indexes compared with those in the placebo group (p=0.02). A significantly greater proportion of patients in the pooled FINTEPLA treatment group also showed benefit on the Plan/Organize scale of the Cognitive Regulation Index compared with the placebo group (p<0.04). No significant, clinically meaningful differences were observed among the treatment groups for worsening of everyday executive function.

Two other presentations at AES include new analyses of data from the Sibling Voices Survey, which was developed by Zogenix to assess the emotional impact of growing up with a sibling with severe childhood epileptic encephalopathies (EE), such as Dravet syndrome and Lennox-Gastaut syndrome. Both analyses involved anonymous sibling and parent respondents representing 107 families of patients with EE, and these new findings again underscore the need to address disease burden on the family in addition to the patient.

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