Top-line results from the Phase III clinical trial of Zogenix’s Fintepla have demonstrated that the primary endpoint was met in patients with Lennox-Gastaut Syndrome (LGS), a type of childhood-onset epilepsy.
Fintepla is an oral solution made up of ZX008 and fenfluramine. It is being developed to treat seizures caused by Dravet and Lennox-Gastaut syndromes.
The first part of the global, multi-centre Phase III trial evaluated the safety, tolerability and efficacy of the drug when given with a patient’s anti-epileptic regimen.
A total of 263 patients aged two to 35 years who had seizures that were uncontrollable using anti-epileptic drugs participated in the trial. Participants were treated with 0.7mg/kg/day or 0.2mg/kg/day Fintepla or placebo.
The primary endpoint was met with a statistically significant decrease in the median percent change in monthly drop seizure frequency from baseline compared to placebo.
Patients on a 0.7mg/kg/day dose of the drug experienced a 26.5% median reduction compared to 7.8% on placebo. The 0.2mg/kg/day dose did not achieve statistical significance on the median percent decrease in monthly drop seizures when compared to placebo.
Fintepla was generally well-tolerated during the trial. The adverse events were observed to be consistent with prior Phase III data in Dravet syndrome.
The most common adverse events in the investigational drug arm were decreased appetite, somnolence, fatigue, vomiting, diarrhoea and pyrexia.
Zogenix president and CEO Stephen Farr said: “We are pleased with the top-line efficacy and safety results from Study 1601, which highlight FINTEPLA’s potential to be an important new treatment option for one of the most difficult to treat rare epilepsies. We look forward to working with regulatory agencies to potentially bring Fintepla to the LGS patient community.”
In October last year, Zogenix reported that Fintepla led to a long-term, clinically meaningful decrease in seizures of study participants with Dravet syndrome.