Rare Daily Staff
Ovid Therapeutics said Takeda Pharmaceutical notified it that two planned pivotal phase 3 studies of their experimental therapy soticlestat for the treatment of Dravet and Lennox Gastaut syndromes, will likely face delays due to enrollment challenges.
In a filing with the U.S. Securities and Exchange Commission, Ovid said the delays related to the geopolitical situation in Ukraine and Russia and COVID-19 lockdowns in China.
Takeda said it is working on multiple approaches to minimize delays, accelerate recruitment, and optimize regulatory timelines for the soticlestat programs. It said the studies are actively recruiting patients and “remain one of Takeda’s highest priority, late-stage programs.”
Takeda estimated on its annual earnings call, held on May 11, 2022, that the primary completion date for the soticlestat studies will be March 2024 and anticipates regulatory filings in its fiscal 2024.
Dravet syndrome and Lennox-Gastaut syndrome are types of developmental and epileptic encephalopathies, a heterogeneous group of rare epilepsy syndromes. Dravet and Lennox-Gastaut syndrome typically become apparent during infancy or early childhood and are highly refractory to many antiseizure medications.
Soticlestat is a potent, highly selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H), with the potential to reduce seizure susceptibility and improve seizure control. CH24H is predominantly expressed in the brain, where it converts cholesterol into 24S-hydroxycholesterol (24HC) to adjust the homeostatic balance of brain cholesterol. 24HC is a positive allosteric modulator of the NMDA receptor and modulates glutamatergic signaling associated with epilepsy. Glutamate is one of the main neurotransmitters in the brain and has been shown to play a role in the initiation and spread of seizure activity.
In 2021, Takeda secured global rights from Ovid to develop and commercialize soticlestat for children and adults with Dravet syndrome and Lennox-Gastaut syndrome. The deal provided Ovid with $196 million in an upfront payment and an additional $660 million in potential milestones. Ovid will also receive tiered royalties beginning in the low double-digits and up to 20 percent on sales of soticlestat, if approved and commercialized. Takeda is responsible for global commercialization.