Zogenix Presents Positive Findings at American Epilepsy Society

Data Presented During Late-Breaker Session at 72^nd American Epilepsy Society Annual Meeting

Additional New Analyses Underscore Psychosocial Burden on Family

Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare diseases, today 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. These data, as well as results from two analyses assessing the impact of Dravet syndrome on patients’ siblings and caregivers, will be presented during the 72^nd American Epilepsy Society (AES) Annual Meeting taking place in New Orleans. Full posters can be found on http://www.zogenix.com here.

In Study 1 (poster 2.406), 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.

“The clinically meaningful impact of FINTEPLA on behavioral and emotional regulation is encouraging, as these are considered the ‘building blocks’ necessary for higher-level cognitive function,” said Gerard A. Gioia, Ph.D., Division Chief, Neuropsychology, Children’s National Health System, Rockville, MD, co-author of the BRIEF and BRIEF2 scales. “Ongoing studies will be important for fully evaluating the longer-term impacts of FINTEPLA treatment on executive function.”

https://www.marketscreener.com/ZOGENIX-INC-22779450/news/Zogenix-Presents-Positive-Findings-on-the-Impact-of-Treatment-with-FINTEPLA-ZX008-on-Everyday-Exe-27693533/