Phase II results show promise for soticlestat in Dravet Syndrome, says GlobalData

Following the news that Takeda and Ovid’s epilepsy drug soticlestat achieved positive Phase II trial results in children with hard-to-treat epilepsy syndromes;

Philippa Salter, Neurology Analyst at GlobalData, a leading data and analytics company, offers her view:

“While the trial ELEKTRA as a whole met its primary endpoint, demonstrating a reduction in seizure frequency, soticlestat performed best in children with Dravet syndrome compared with Lennox-Gastaut syndrome (LGS). As such, it is expected that the focus will be on Dravet syndrome moving forward, with a Phase III study in just this patient population expected. If soticlestat can be shown to still be effective in a larger Phase III trial GlobalData expects global annual revenue of $667m by 2026.

“Although the results were not statistically significant when looking at just LGS, it could still be possible for the companies to move forward with this indication if further analysis of the trial data shows that soticlestat is effective for a sub-set of LGS patients.

“Any drug being developed for these syndromes will face the challenge of having to compete with GW Pharmaceutical’s Epidiolex, which currently dominates the market. Not only does Epidiolex have first-to-market advantage, but as a cannabis-derived drug it also has strong patient advocacy behind it. In future Phase III trials, soticlestat has the potential to demonstrate more efficacy for Dravet syndrome than Epidiolex, allowing it to compete in this space.

“As Dravet syndrome and LGS are generally treatment resistant to typical antiepileptic drugs, more treatment options are needed, particularly for patients who do not respond to Epidiolex.”

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