London: Japanese drugmaker Takeda said on Monday that its experimental drug has been under testing for two years Epileptic disorders failed to reduce the frequency of seizures in patients final stage studies,
Medicine, SoticalstateThe trial was being conducted in combination with standard-of-care treatment in adults and children Dravet Syndrome (DS) and Lennox-Gastaut syndrome (LGS) – a rare and severe form of epilepsy characterized by frequent, prolonged seizures that usually appear in infancy or early childhood.
According to Takeda, DS affects about one in 21,000 people in the United States, and LGS affects less than one in 1,000.
Treatments currently available in the U.S. for both conditions include Jazz Pharmaceuticals’ cannabis-based drug Epidiolex and Belgian biotech company UCB SA’s Fintepla.
Takeda acquired the global rights to soticlestat from Ovid Therapeutics in 2021 for an upfront payment of $196 million. Under the agreement, Ovid could also receive payments of up to $660 million if the drug achieves certain developmental and regulatory milestones.
Ovid shares fell 64.7% to $1.16 in premarket trading.
In a late-stage study involving 144 patients aged 2 to 21 years with Dravet syndrome, the combination of soticlestat and an antiseizure therapy did not help reduce the frequency of convulsive seizures after 16 weeks of treatment, marginally achieving the main goal of the study.
Takeda said the drug showed “nominally significant” improvements in secondary targets such as seizure intensity and duration.
The combination of soticlestat and antiseizure therapy also failed to reduce a serious type of seizure called drop attacks in patients with Lennox-Gastaut syndrome. The study included 270 patients aged 2 to 55 years.
Takeda said the drug was found to be generally safe and well-tolerated in both studies.
Takeda plans to discuss with regulatory authorities to determine next steps for the drug. It is also assessing the financial implications of the study results.
(Reporting by Mariam Sunny in Bengaluru; Editing by Shailesh Kuber and Devika Shyamnath)
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