Addex stock battered after J&J-partnered drug fails mid-stage epilepsy study

29 Apr 2024
firstwordpharma.com
Phase 2Clinical Result
Shares in Addex Therapeutics more than halved on Monday after the experimental drug ADX71149 – which stems from a long-term partnership with Johnson & Johnson – failed to meet the primary endpoint of a Phase II study in patients with epilepsy. Addex’s chief medical officer Roger Mills said that once further analysis of the data is completed, the company “will work with our partner to determine next steps for the…programme.”
Addex joined forces with Johnson & Johnson back in 2004 to develop mGlu2 receptor positive allosteric modulators with ADX71149 - also known as JNJ-40411813 - being studied in a number of conditions, including major depressive disorder. However, results released around a decade ago did not support further work in this setting, and the focus subsequently shifted to epilepsy.
The latest trial enrolled patients with focal onset seizures who have had a suboptimal response to levetiracetam or brivaracetam. Subjects were administered adjunctive ADX71149 in combination with levetiracetam or brivaracetam, with the study using a time to baseline seizure count endpoint for the main goal.
Ahead of the readout, HC Wainwright analysts said they were “maintaining a cautious outlook until the Phase II data confirm the hypothesis underlying utility of this candidate in seizure-related conditions.”
The caution seems justified as top-line data revealed that the trial did not achieve statistical significance for the primary endpoint. The results - which sent Addex’s down as much as 52% - were reported from a total of 110 evaluable patients, who each received either 50mg or 100mg of ADX71149 twice daily.
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