ADX71149 for the treatment of epilepsy.
ADX71149 is a selective metabotropic glutamate sub-type 2 (mGlu2) receptor positive allosteric modulator (PAM).
Our partnered drug candidate, ADX71149 is a novel orally active mGlu2 PAM for the treatment of epilepsy. Our partner, Janssen Pharmaceuticals, Inc., or Janssen, a subsidiary of Johnson & Johnson is conducting a placebo-controlled Phase 2 clinical trial of ADX71149 in epilepsy patients since June 2021. 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. Up to 3 doses (low, medium, high) of ADX71149 in up to 160 patients will be evaluated. 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. Subjects who do not reach or exceed 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. Cohort 1 has completed Part 1 and is currently in Part 2. Cohort 2 has started to recruit patients in Part 1. 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 for up to 2 years. More information on the study can be found with Clinicaltrials.gov identifier NCT04836559.
Under our agreement with Janssen, Janssen is responsible for financing the development and commercialization, if any, of ADX71149.