Swiss drugmaker Idorsia Ltd's experimental insomnia drug daridorexant produced positive results in a late-stage clinical trial, the company said on Monday.
The first pivotal phase-3 study investigating 25 and 50 mg doses of the dual orexin receptor antagonist in 930 adult and elderly patients showed it helped people fall asleep and stay asleep and improved their daytime performance, Idorsia said.
It found no residual effect in the morning, and no evidence of rebound or withdrawal symptoms when treatment stopped, it added in a statement.
"While we designed daridorexant to have the optimal profile for a sleep medicine, I am nonetheless stunned by the results," Chief Executive Jean-Paul Clozel said.
Clozel told Reuters in February he was sticking to plans to seek regulatory approval for daridorexant, also called DORA, this year and hoped for a worldwide launch at the close of 2021 or the start of 2022.
Idorsia was founded from assets left over after Clozel sold his first biotech business, Actelion, to Johnson & Johnson in 2017 for $30 billion.
Investors reacted positively to the development, with Idorsia's stock gaining nearly 9% in early activity on the Swiss bourse.
"Today's news is positive, but was expected by us as outlined in our recent reports," said Bank Vontobel analyst Stefan Schneider.