Zogenix said Monday that new data demonstrated the mechanism of action of ZX008, a low-dose fenfluramine treatment being developed as an adjunctive treatment for Dravet syndrome, a rare epileptic encephalopathy. “The assumption to date has been that the anti-seizure activity of fenfluramine is mediated through known, primarily serotonergic mechanisms. However, the meaningful and prolonged reductions in seizure frequency observed following the use of fenfluramine in patients with DS has not been replicated in studies with other serotonergic agents, such as fluoxetine and lorcaserin. These new results exploring mechanism of action demonstrate that fenfluramine, in addition to its serotonergic effects, also exhibits activity at the sigma-1 receptor,” the company said in a statement.
Zogenix’s phase 3 program for ZX008 is further evaluating the potential of low-dose fenfluramine as an adjunctive treatment for seizures in Dravet syndrome. Data from the company’s first phase 3 clinical trial is expected in Q3.