We already know that Takeda is hoping to find a path to the FDA for epilepsy medicine soticlestat despite a phase 3 miss but the Japanese pharma has now revealed that the clinical trial failure will cost the company about $140 million.
Takeda reported an impairment charge of JPY 21.5 billion, the equivalent of about $143 million in a fiscal year 2024 first-quarter earnings report (PDF) Wednesday. The charge was booked in the quarter, taking a chunk out of operating profit amid a company-wide restructuring.
The soticlestat results were reported in June, showing that the Ovid Therapeutics-partnered asset failed to reduce seizure frequency in patients with refractory Lennox-Gastaut syndrome, a severe form of epilepsy, missing the primary endpoint of the late-stage test.
Another phase 3 trial in patients with Dravet syndrome also failed on the primary goal, although to a lesser extent. The study narrowly missed the primary endpoint of reduction from baseline in convulsive seizure frequency as compared to placebo and met secondary objectives.
Takeda had been hoping for much stronger results to make up for the $196 million that was paid to Ovid in 2021.
But the company pointed to the “totality of the data” as a glimmer of hope that soticlestat could one day earn an FDA nod anyway. Takeda promised to engage regulators to discuss the path forward.
The tune was the same in this week’s earnings report, with Takeda suggesting that there still could be a clinically meaningful benefit for patients with Dravet syndrome despite the primary endpoint miss. Soticlestat has an orphan drug designation from the FDA for the seizure disorder.
So soticlestat still had a prime position on Takeda’s pipeline chart in the earnings presentation Wednesday.
“The totality of data from this study with meaningful effects on key secondary endpoints, combined with the highly significant results from the large phase 2 study, suggest clear clinical benefits for soticlestat in Dravet patients with a differentiated safety profile,” said Andrew Plump, M.D., Ph.D., Takeda’s director and president of R&D, during the company’s earnings call. “Given the large unmet medical need, we are investigating a potential regulatory path forward.”