Addex Therapeutics announced that the last patient has been randomized in Cohort 2 of the ADX71149 (JNJ-40411813) Phase 2 epilepsy clinical study. Results evaluating the efficacy, safety and tolerability of ADX71149 in combination with levetiracetam or brivaracetam from patient Cohorts 1 and Cohort 2 are anticipated for the second quarter of 2024. The primary efficacy endpoint of this study is time to baseline monthly seizure count.

The trial is being conducted in collaboration with Janssen Pharmaceuticals Inc., a Johnson & Johnson company. ADX71149 is a selective metabotropic glutamate sub-type 2 (mGlu2) receptor positive allosteric modulator (PAM). The multi-center Phase 2 study has been designed to assess the efficacy, safety, tolerability, and pharmacokinetics of adjunctive ADX71149 administration in patients with focal onset seizures with suboptimal response to levetiracetam or brivaracetam.

The primary objective of the study is to evaluate the efficacy of ADX71149 in combination with levetiracetam or brivaracetam using a time to baseline seizure count endpoint. Part 1 of the study evaluates the acute efficacy of ADX71149 over 4 weeks. Patients who do not reach their monthly baseline seizure count in Part 1 continue double-blind treatment during Part 2 until they reach their monthly baseline seizure count or 8 weeks, deemed the maintenance efficacy phase.

In addition, patients who complete Part 1 and/or Part 2 of the study have the option to continue treatment in the open-label extension part of the study, which evaluates the long-term efficacy and safety of ADX71149. More information on the study can be found with Clinicaltrials.gov identifier NCT04836559.