Zogenix's Fintepla Associated With Improvements in Seizure Control, Executive Functions In Childhood Epilepsy Disorder

  • Zogenix Inc (NASDAQ: ZGNX) has announced new data showing the positive impact of treatment with Fintepla (fenfluramine) on everyday executive function for children and young adults with Lennox-Gastaut syndrome (LGS), a rare and severe kind of childhood epilepsy characterized by different types of seizures.

  • These posthoc analysis data were presented at the virtual American Academy of Neurology (AAN) Annual Meeting.

  • The objective of this posthoc analysis was to assess the impact of the treatment with abilities to self-regulate behavior, emotions, and cognition as part of a 14-week Phase 3 trial in 263 LGS patients aged 2-35 years.

  • More LGS study patients treated with Fintepla showed improvement in behavior, emotion, and cognitive function in intractable epilepsy and other developmental conditions.

  • Improvement was statistically significant for cognition (27% vs. 13% placebo, p=0.046) and the composite score (25% vs. 11% placebo, p=0.034), wherein around twice as many patients achieved clinically meaningful improvement.

  • Fintepla oral solution has been approved by the FDA and the European Medicines Agency and is in development in Japan to treat seizures associated with Dravet syndrome.

  • The company has two additional late-stage development programs, one in Lennox-Gastaut syndrome and one in a mitochondrial disease called TK2 deficiency.

  • Price Action: ZGNX shares are up 2.01% at $19.33 in market trading hours on the last check Thursday.

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