Partner Halts ADX71149 Development for Epilepsy

Addex Therapeutics, a biopharmaceutical company based in Geneva, Switzerland, announced on July 22, 2024, that its partner J&J Innovative Medicine (formerly Janssen Pharmaceuticals, Inc.) has ceased the development of ADX71149 (also known as JNJ-40411813) for the treatment of epilepsy. Despite this setback, the partnership between Addex and J&J Innovative Medicine remains intact as they continue to analyze the complete data set from the Phase 2 study of ADX71149 as an adjunctive treatment for epilepsy.

The decision to discontinue the development of ADX71149 follows the results of a Phase 2 study released on April 29, 2024. The study aimed to assess the efficacy of ADX71149 in patients with focal onset seizures who had an inadequate response to the antiepileptic drugs levetiracetam or brivaracetam. Unfortunately, the study did not meet its primary endpoint, which was to measure the time it took for patients to return to their baseline seizure count when ADX71149 was added to their standard treatment.

Tim Dyer, CEO of Addex Therapeutics, commented on the decision, noting that it was anticipated given the Phase 2 study results. He emphasized the strong, long-standing collaboration with J&J Innovative Medicine and expressed their commitment to thoroughly analyzing the Phase 2 data to gain comprehensive insights from the study. The company expects to make a decision on the future of ADX71149 once the full data analysis is complete.

The Phase 2 study of ADX71149 was a multi-center trial designed to evaluate the drug’s efficacy, safety, tolerability, and pharmacokinetics when used as an adjunctive therapy for focal onset seizures. The primary objective was to determine if ADX71149, in combination with levetiracetam or brivaracetam, could effectively reduce seizure frequency. The study was conducted in two parts: the first part assessed the acute efficacy of ADX71149 over four weeks, while the second part continued the double-blind treatment for up to eight weeks or until patients achieved their baseline seizure count.

ADX71149 is a selective positive allosteric modulator (PAM) of the metabotropic glutamate subtype 2 (mGlu2) receptor, which plays a critical role in regulating glutamate levels in the brain. Glutamate is the primary excitatory neurotransmitter and is closely linked to seizure activity. By modulating the mGlu2 receptor, ADX71149 aims to normalize excessive glutamate release, potentially helping to control seizures.

Epilepsy remains a significant medical challenge, with many patients struggling to manage their symptoms effectively. Despite the discontinuation of ADX71149 development for epilepsy, Addex remains committed to advancing treatments for neurological disorders. The company’s collaboration with J&J Innovative Medicine includes the development and commercialization of mGlu2 PAM compounds, with Addex eligible for milestone payments and royalties based on the success of these compounds.

Addex Therapeutics is focused on developing innovative small molecule allosteric modulators for various neurological conditions. In addition to ADX71149, the company’s pipeline includes dipraglurant, an mGlu5 negative allosteric modulator (NAM) being developed for dyskinesia associated with Parkinson’s disease and post-stroke recovery. Addex is also advancing drug candidates for substance use disorder in partnership with Indivior and has an independent program for chronic cough. Furthermore, Addex holds a stake in Neurosterix LLC, which is working on multiple allosteric modulator programs for neurological and psychiatric disorders.

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