Zogenix Announces New Efficacy and Safety Data for ZX008 in Treatment of Seizures in Lennox Gastaut Syndrome & Dravet Syndrome
- New Clinical Data Presented at 70th Annual American Epilepsy Society Meeting
- Posters Highlighting Potential Protective Effect of ZX008 in Pre-Clinical Model of Sudden Unexpected Death in Epilepsy (SUDEP) and Results of Roundtable Discussions Evaluating Burden of Illness on Caregivers in Dravet Syndrome Also Presented
- Company Evaluating Potential Phase 3
Program for ZX008in Lennox Gastaut Syndrome
The LGS data presented were from an interim analysis of the first 13 patients to have completed at least 12 weeks of a Phase 2 open-label, dose-finding investigator-initiated study, led by
There were no cardiovascular-related adverse events observed. The most common treatment-related adverse events were decreased appetite (n=3), decreased alertness/fatigue (n=3) and insomnia (n=2). Three patients withdrew due to adverse events (decreased alertness (n=2) and insomnia (n=1) and one patient withdrew due to lack of effect (the patient was initially a responder, but lost response after undergoing surgery during the trial).
“These initial results for ZX008 in LGS are quite compelling for this refractory group of patients,” said Professor Lagae. “A significant unmet medical need currently exists in the treatment of LGS and these initial data indicate that ZX008 has the potential to be a safe and effective adjunctive treatment for this rare pediatric epilepsy condition. I look forward to continuing to evaluate ZX008 in this ongoing Phase 2 open-label study.”
The Dravet syndrome data highlighted updated results from the ongoing prospective study in
Treatment with low-dose fenfluramine continues to be generally well-tolerated. The most common treatment-emergent adverse events were mild-to-moderate somnolence (n=5) and anorexia (n=4). No evidence of cardiac valvulopathy or pulmonary hypertension was observed in any patient on any echocardiogram. There were no patient discontinuations.
Two additional posters were also presented in the main exhibit hall at the
The second poster highlighted the findings from roundtable discussions with parents and caregivers of children with Dravet syndrome that sought to identify those aspects of caregivers’ lives that are most impacted by caring for a child with Dravet syndrome (see study data here). These roundtable discussions identified significant impacts on the lives of these families in four overarching areas: physical, mental, social, and financial. Future work by this group will focus on developing a validated measure of caregiver burden in Dravet syndrome.
“The Zogenix team is extremely pleased with all of the data presented at this year’s
Zogenix’s Phase 3 program for Dravet syndrome continues to enroll patients in the U.S. and internationally, and the Company expects the availability of Phase 3 top-line data in Dravet syndrome in the second quarter of 2017, and potential regulatory submissions for approval to occur by year-end 2017. ZX008 is designated as an orphan drug in both the U.S. and Europe, and also received Fast Track designation in the U.S., for the treatment of Dravet syndrome.
For more information, visit www.zogenix.com.
Forward Looking Statements
Andrew McDonaldFounding Partner, LifeSci Advisors LLC646-597-6987 | Andrew@lifesciadvisors.com