J&J halts Addex-partnered epilepsy drug after failed phase 2 trial

Johnson & Johnson has decided to stop the development of its epilepsy drug, ADX71149, co-developed with Addex Therapeutics. This decision follows the disappointing results from a mid-stage clinical trial overseen by Janssen, a unit of Johnson & Johnson. The trial involved 110 patients whose focal onset seizures were not adequately controlled by the approved epilepsy medications levetiracetam or brivaracetam.

ADX71149, a positive allosteric modulator of metabotropic glutamate receptor-2, originated from a collaboration between Addex and Janssen that began in 2004. However, results revealed in late April indicated that the drug did not meet its primary endpoint. Specifically, it failed to demonstrate a delay in the time it took for patients to reach their baseline seizure count.

During a June 6 earnings call, Tim Dyer, CEO of Addex, mentioned that Janssen was still analyzing the full data set from the trial before making a final decision. He noted that one possible outcome could be the termination of the collaboration, with Addex regaining control of the molecule and its backup compounds. Dyer emphasized that a complete understanding of the data was necessary to determine if there was a feasible path forward for the drug in epilepsy treatment.

When Johnson & Johnson announced its earnings on a later date, ADX71149—also known as JNJ-40411813—was conspicuously missing from the updated pipeline. The company confirmed via email that it had officially notified Addex of its decision to discontinue the development of ADX71149 as an epilepsy treatment. A J&J spokesperson also mentioned that they were working closely with trial sites to inform the enrolled patients so they could seek alternative treatment options. Additionally, the spokesperson clarified that this decision does not affect their overall partnership and collaboration with Addex.

Fierce Biotech reached out to Addex to inquire whether the company plans to continue the development of ADX71149 independently. Addex, based in Geneva, has other clinical-stage assets in development, notably a mGlu5 negative allosteric modulator called dipraglurant. Despite facing challenges, such as inconclusive data from a phase 2 trial designed for muscle spasm disorders and delays caused by the COVID-19 pandemic, Addex continues to explore dipraglurant's potential. The company is evaluating it as a treatment for dyskinesia associated with Parkinson’s disease and for recovery from post-stroke or traumatic brain injury.

In conclusion, while Johnson & Johnson has chosen to halt the development of ADX71149 for epilepsy, Addex may still have future plans for the drug. The ongoing collaboration between the two companies remains intact, and Addex is actively pursuing other therapeutic avenues, especially with dipraglurant. The future of ADX71149 remains uncertain, pending further analysis and possible independent development by Addex.