Zogenix has reported that its Fintepla drug led to a long-term, clinically meaningful decrease in seizures of study participants with Dravet syndrome.
The new data was obtained from an ongoing open-label extension (OLE) trial named Study 1503 and post hoc analysis of two prior Phase III clinical trials, Study 1 and Study 1504.
Fintepla is an investigational drug consisting of ZX008 and fenfluramine. It is being developed to treat seizures caused by Dravet and Lennox-Gastaut syndromes, which are rare, childhood-onset epilepsies.
The drug was found to reduce convulsive seizure frequency in patients aged six and under.
At the time of analysis, a 75.5% median decrease in monthly convulsive seizure frequency was observed in patients aged six and under compared to baseline, while the decrease was 60.1% in those aged above six years and 63.6% in patients aged two to 18.
The Phase III trials showed that Fintepla reduced high-risk tonic-clonic (grand-mal) seizure frequency.
A total of 206 patients were recruited as part of the trial. Data showed an 80%, 64% and 48% median decrease in monthly generalised tonic-clonic seizures with 0.7mg/kg a day, 0.4mg/kg a day and 0.2mg/kg a day doses of the drug, respectively.
Meanwhile, the decrease was 10% in the placebo group.
In addition, 97%, 33% and 69% median decrease in monthly focal-to-bilateral tonic-clonic seizures was reported for the 0.7mg/kg a day, 0.4mg/kg a day, and 0.2mg/kg a day doses versus 39% for those on placebo.
Zogenix executive vice-president and chief medical officer Bradley Galer said: “These data continue to demonstrate the significant clinical impact Fintepla has shown in studies of Dravet syndrome patients.
“These new results clearly show the impact this drug candidate has had on some of the most vulnerable patients, those who are younger than six years of age, as well as those suffering from generalised tonic-clonic seizures, a recognised risk factor for sudden unexplained death in epilepsy (SUDEP).”
The drug was generally well-tolerated in all studies, without any valvular heart disease or pulmonary arterial hypertension occurrences.