March 9 (Reuters) – Xenon Pharmaceuticals said on Monday its experimental epilepsy drug met the main goal of showing a statistically significant reduction in focal onset seizures in a late-stage trial, sending its shares up 53% before the bell.
The company was testing azetukalner in patients with focal onset seizures, a form of epilepsy characterized by seizures that originate in one area of the brain.
In the late-stage study, patients treated with azetukalner saw a median reduction in monthly seizure frequency of 53.2% at the 25 mg dose and 34.5% at the 15 mg dose, compared with 10.4% for placebo over 12 weeks.
The placebo-adjusted reduction for the 25 mg dose was 42.7%, which the company said exceeded results seen in earlier studies.
“Investors were debating if the bar should be 25% or 30% on a placebo-normalized basis and the data clearly blasts through both,” said William Blair analyst Myles Minter.
More than half of those given the 25 mg dose saw their seizure frequency cut by at least half, compared with 20.8% of patients on placebo.
“We believe that strong efficacy demonstrated by azetukalner in its topline data exceeded investor expectations, delivering the best placebo-adjusted efficacy of any other antiseizure medicine tested in pivotal trials,” said RBC Capital Markets analyst Brian Abrahams.
The drug works by enhancing Kv7 channel activity to stabilize over‑active neurons and help prevent the abnormal electrical firing that leads to seizures.
The drug developer said it plans to submit a marketing application to the U.S. Food and Drug Administration in the third quarter.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Janane Venkatraman, Sriraj Kalluvila and Maju Samuel)
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