Monday, Addex Therapeutics ADXN launched top-line information from a Section 2 epilepsy examine evaluating adjunctive ADX71149 (JNJ-40411813) administration in sufferers with focal onset seizures with suboptimal response to levetiracetam or brivaracetam.
The corporate is collaborating with Johnson & Johnson’s JNJ Janssen Prescription drugs Inc.
The Section 2 examine didn’t obtain statistical significance for the first endpoint of time for sufferers to succeed in baseline seizure rely when ADX71149 was added to the usual of care.
“Whereas dissatisfied that the Section 2 ADX71149 epilepsy examine didn’t meet the first endpoint, we’re nonetheless analyzing the information,” mentioned Roger Mills, Chief Medical Officer of Addex.
“We are going to present particulars on information from the complete examine when this evaluation is accomplished and can work with our companion to find out the following steps for the ADX71149 program,” Mills added.
The information had been reported from a complete of 110 evaluable sufferers, who every acquired both 50 mg or 100 mg of ADX71149 twice day by day (100 mg or 200mg twice day by day, respectively, for sufferers receiving CYP3A4 inducing anti-seizure remedy) along with their normal dose of levetiracetam or brivaracetam and as much as three different anti-seizure medicine.
Adjunctive administration of ADX71149 was protected and nicely tolerated.
“Whereas that is disappointing information for us and our companion, Janssen, we stay centered on advancing the remainder of our portfolio of allosteric modulator packages towards medical research,” mentioned Tim Dyer, CEO of Addex. “Specifically, we’re making nice progress in our GABAB PAM collaboration with Indivior, which is on monitor to pick out drug candidates for IND enabling research in June this yr for substance use dysfunction and power cough packages.”
Value Motion: ADXN shares are down 50.4% at $7.99 on the final test Monday.
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