Takeda’s soticlestan misses main goal of two pivotal epilepsy studies

17 Jun 2024
firstwordpharma.com
Clinical ResultClinical Study
Two late-stage studies of Takeda’s experimental drug soticlestan in patients with Dravet syndrome and Lennox-Gastaut syndrome failed to meet their primary endpoints, although the company pointed out that one of the trials only “narrowly” missed, offering a glimmer of hope for the selective CH24H inhibitor.
“While we would have wished for more declarative results on the primary endpoints, we are encouraged by positive outcomes seen in the totality of the data and are looking forward to engaging health authorities to determine the best path forward,” remarked Sarah Sheikh, head of global development at Takeda.
The SKYLINE study included 144 paediatric and young adult participants with refractory Dravet syndrome, while the SKYWAY trial enrolled 270 paediatric and adult patients with Lennox-Gastaut syndrome. In both studies, participants were randomised to receive soticlestat or placebo twice daily for 16 weeks on top of their current antiseizure therapy.
SKYLINE’s primary endpoint was percent change from baseline in convulsive seizure frequency per 28 days, while the main goal of SKYWAY was percent change from baseline in major motor drop (MMD) seizure frequency per 28 days.
Top-line results showed that soticlestat narrowly missed the primary endpoint in SKYLINE, with a p-value of 0.06. Takeda added that in the study, the drug showed clinically meaningful and nominally significant results in a number of key secondary goals, including responder rate, and seizure intensity and duration scales. The company did not provide details of how soticlestat fared on secondary endpoints in the SKYWAY trial.
Takeda indicated that the drug, also known as TAK-935, was generally well tolerated in both studies. The drugmaker said it will assess the financial impacts of the results, including any impairment loss for intangible assets, having paid nearly $200 million back in 2021 to regain full rights to soticlestat from Ovid Therapeutics.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
Drugs
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.