J&J and Addex first partnered in 2004 to develop the positive allosteric modulator (PAM) of metabotropic glutamate receptor-2 (mGlu2 receptor), ADX71149 (JNJ-40411813). Image Credit: SERSOLL / Shutterstock.

Addex Therapeutics’s lead drug candidate, developed in collaboration with Johnson and Johnson (J&J), has failed to meet endpoints in a Phase II trial.

Following the release of the Phase II top-line results, the Swiss company’s stock was down by 53.3% at the market close on 29 April compared to the market close on the previous day. According to Yahoo Finance, Addex’s market cap stands at $8.8m.

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The placebo-controlled Phase II trial (NCT04836559) evaluated ADX71149 (JNJ-40411813) as an adjunct therapy in 110 patients with epilepsy. The study failed to achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count.

Addex did not provide additional information regarding the future of the drug’s development. However, the company’s chief medical officer, Roger Mills, added: “We will provide details on data from the full study when this analysis is completed and will work with our partner to determine the next steps for the ADX71149 program.”

ADX71149 is a positive allosteric modulator (PAM) of metabotropic glutamate receptor-2 (mGlu2 receptor), which plays a key role in seizure initiation and spread. The drug was developed as part of a partnership with J&J signed back in 2004.

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Earlier this month, Addex spun out a new company, Neurosterix, to develop its preclinical neurological assets. In exchange for the drug candidates and technology, Addex received SFr5m ($5.5m) and 20% equity in Neurosterix.

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Addex has also partnered with Indivior and is developing the gamma-aminobutyric acid subtype B (GABA-B) PAM asset, INDV-1000. The therapy is in preclinical development, with plans to select drug candidates for an investigational new drug (IND), enabling studies in June for the substance use disorder and chronic cough programs.

Other allosteric modulator assets in the Addex pipeline include dipraglurant and a GABA-B PAM candidate for the treatment of chronic cough. The company plans to start a Phase II trial evaluating dipraglurant, a metabotropic glutamate subtype 5 (mGlu5) negative allosteric modulator (NAM), for post-stroke sensorimotor recovery this year.

The use of PAMs for treating neurological disorders has been an area of focus in recent months. In December 2023, AbbVie agreed to acquire Cerevel Therapeutics for $8.7bn. Emraclidine, a selective M4 receptor PAM, was at the centre of the deal.