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Epilepsy Treatment In Limbo As Addex’s Partner Abandons ADX71149

Janssen stops ADX71149 development for epilepsy; Addex and Janssen still analyzing Phase 2 data.

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  • Jul 22, 2024

  • Mrudula Kulkarni

Epilepsy Treatment In Limbo As Addex’s Partner Abandons ADX71149

Addex Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing innovative small molecule allosteric modulators for neurological disorders, has announced that Janssen Pharmaceuticals, Inc. (now J&J Innovative Medicine) has decided to halt the development of ADX71149 (JNJ-40411813) for epilepsy. Despite this, the collaboration between the two companies will continue as they analyze the complete data set from the Phase 2 study of ADX71149 as an adjunctive treatment for epilepsy.

This decision comes after the release of top-line Phase 2 data on April 29, 2024. The data revealed that the adjunctive administration of ADX71149 in patients with focal onset seizures, who had an inadequate response to levetiracetam or brivaracetam, did not reach statistical significance for the primary endpoint. This endpoint was the time it took for patients to return to their baseline seizure count when ADX71149 was added to their standard care regimen.

ADX71149 is a targeted positive allosteric modulator (PAM) of the selective metabotropic glutamate subtype 2 (mGlu2) receptor. The multi-center Phase 2 trial aimed to evaluate the efficacy, safety, tolerability, and pharmacokinetics of ADX71149 as an adjunct therapy in patients with focal onset seizures who had an inadequate response to levetiracetam or brivaracetam. The main goal was to determine the effectiveness of ADX71149 when used alongside levetiracetam or brivaracetam by measuring the time it took for patients to return to their baseline seizure count.

The study had two parts: Part 1 assessed the short-term effectiveness of ADX71149 over four weeks. Patients who did not reach their monthly baseline seizure count during this period continued in the double-blind treatment phase (Part 2), which lasted until they either reached their monthly baseline seizure count or completed eight weeks, known as the maintenance efficacy phase. Detailed information about the study is available under Clinicaltrials.gov identifier NCT04836559.

Glutamate is the brain's main excitatory neurotransmitter, playing a crucial role in the onset and spread of seizures. Activation of the mGlu2 receptor reduces glutamate release, helping to balance neurotransmitter levels. Positive allosteric modulation of mGlu2 receptors, when triggered by agonists, can normalize the excessive glutamate release observed during seizures. Epilepsy remains a significant unmet medical need, with many patients facing challenges in managing their seizures daily.

Through their research collaboration and license agreement, Addex has provided Janssen Pharmaceuticals, Inc. with an exclusive global license to develop and commercialize mGlu2 PAM compounds. Addex stands to receive up to €109 million in success-based development and regulatory milestone payments. Additionally, Addex is eligible for low double-digit royalties on net sales of compounds developed under this agreement.

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