Takeda's seizure drug fails to meet main goal in late-stage studies

Takeda Pharmaceutical Co's logo is seen at its new headquarters in Tokyo

(Reuters) -Japanese drugmaker Takeda said on Monday its experimental drug being tested for two epileptic disorders failed to reduce frequency of seizures in patients across late-stage studies.

The drug, soticlestat, was being tested in combination with standard-of-care treatment in adults and children with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) - rare and severe forms of epilepsy characterized by frequent, prolonged seizures that typically manifest in infancy or early childhood.

DS affects about one in 21,000 people and LGS affects fewer than one in 1,000 people in the United States, according to Takeda.

The treatments currently available in the U.S. for both the conditions include Jazz Pharmaceuticals' cannabis-based drug Epidiolex and Belgian biotech firm UCB SA's Fintepla.

Takeda acquired 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 upon the drug achieving certain developmental and regulatory milestones.

Shares of Ovid slumped 64.7% to $1.16 in premarket trading.

In a late-stage study that enrolled 144 patients aged 2 to 21 years with Dravet syndrome, a combination of soticlestat and an antiseizure therapy did not help reduce the frequency of convulsive seizures after 16 weeks of treatment, narrowly missing the main goal of the study.

Takeda said the drug showed "nominally significant" improvement in secondary goals like seizure intensity and duration.

A soticlestat and antiseizure therapy combination also failed to reduce a severe type of seizure called the drop attack in patients with Lennox-Gastaut syndrome. This study enrolled 270 patients aged 2 to 55 years.

The drug was generally safe and well-tolerated across both the studies, Takeda said.

Takeda plans to discuss with regulatory authorities to determine the next steps for the drug. It is also assessing the financial impacts of the study results.

(Reporting by Mariam Sunny in Bengaluru; Editing by Shailesh Kuber and Devika Syamnath)