Takeda's seizure drug fails to meet main goal in late-stage studies
Adds details in paragraphs 6-10, Ovid shares in paragraph 13, background throughout
June 17 (Reuters) -Japanese drugmaker Takeda 4502.T TAK.N saidon Monday its experimental drug being tested for two epileptic disorders failed to reduce frequency of seizures in patientsacross 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 characterizedby frequent, prolonged seizures thattypically manifest ininfancy 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' JAZZ.O cannabis-based drug Epidiolex and Belgian biotech firm UCB SA's UCB.BR Fintepla.
Takeda acquired global rights to soticlestat from Ovid Therapeutics OVID.O 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-toleratedacross both the studies, Takeda said.
Takeda plansto discuss with regulatory authorities to determine the nextsteps for the drug. It is also assessing the financial impacts of the studyresults.
Reporting by Mariam Sunny in Bengaluru; Editing by Shailesh Kuber and Devika Syamnath
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