Monday, Addex Therapeutics ( ADXN ) released top-line data from a Phase 2 epilepsy study evaluating adjunctive ADX71149 (JNJ-40411813) administration in patients with focal onset seizures with suboptimal response to levetiracetam or brivaracetam. 

The company is collaborating with Johnson & Johnson’s  Janssen Pharmaceuticals Inc.

The Phase 2 study did not achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count when ADX71149 was added to the standard of care.

“While disappointed that the Phase 2 ADX71149 epilepsy study did not meet the primary endpoint, we are still analyzing the data,” said Roger Mills, Chief Medical Officer of Addex. 

“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,” Mills added.

The data were reported from a total of 110 evaluable patients, who each received either 50 mg or 100 mg of ADX71149 twice daily (100 mg or 200mg twice daily, respectively, for patients receiving CYP3A4 inducing anti-seizure medication) in addition to their standard dose of levetiracetam or brivaracetam and up to three other anti-seizure drugs. 

Adjunctive administration of ADX71149 was safe and well tolerated.

“While this is disappointing news for us and our partner, Janssen, we remain focused on advancing the rest of our portfolio of allosteric modulator programs toward clinical studies,” said Tim Dyer, CEO of Addex. “In particular, we are making great progress in our GABAB PAM collaboration with Indivior, which is on track to select drug candidates for IND enabling studies in June this year for substance use disorder and chronic cough programs.”

Price Action: ADXN shares are down 50.4% at $7.99 at the last check Monday.

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