By Chris Wack
Addex Therapeutics Ltd. said its partner, Janssen Pharmaceuticals Inc., has received the U.S. Food and Drug Administration's Investigational New Drug approval to begin a Phase 2a proof of concept study for a treatment for patients with epilepsy.
The clinical-stage pharmaceutical company said the first patient is expected to be treated during the second quarter of 2021.
Addex said the multi-center study will assess the efficacy, safety, tolerability and pharmacokinetics of adjunctive JNJ-40411813 administration in patients with focal onset seizures with suboptimal response to levetiracetam.
The primary objective of the study is to evaluate the efficacy of JNJ-40411813 in combination with levetiracetam using a time-to-event endpoint.
Addex Therapeutics shares were up 65% to $17.79 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
01-21-21 0628ET