Expert Interview
Examining Addex Therapeutics' ADX71149/JNJ-40411813 in combination with Levetiracetam or Brivaracetam in patients with Epilepsy
Ticker(s): ADXN, JNJInstitution: George Washington University
- Current Adjunct Associate Professor of Neurology at George Washington University; Former Instructor of Neurology at Harvard Medical School and former Director of the Epilepsy Program at the Georgetown University Hospital.
- Manages approximately 1500 patients with epilepsy.
- Clinical research focuses on novel treatments of epilepsy, dietary treatments of epilepsy in adults, and prevention of epilepsy after traumatic brain injury.
Please describe your clinical practice, in particular with treating epilepsy, how many patients do you currently manage?
Added By: dami_adminOn a scale of 1-10 (10 being extremely excited), how would you rate your level of excitement for ADX71149/JNJ-40411813?
Added By: dami_adminIn this clinical trial, is the dose of Levetiracetam limited by side-effects or perceived maximal effect possible?
In other words; dose the dose (but not effect) synergism seen in preclinical studies inform the clinical trial?
What preclinical data would give you confidence in ADX71149/JNJ-40411813 trial given preclinical seizure models often fail to translate to human efficacy in the drug-resistant setting?
Can you recommend a method to run levetiracetam drug-resistant seizure mice models?
Are there any lessons learned or read-throughs from padsevonil's (SV2A + GABA) focal-onset seizure trial failure, given patients in ADX71149/JNJ-40411813 trial will be re-challenged with levetiracetam's SV2A mechanism after levetiracetam failure ?
Added By: kennyWhat are your thoughts on re-challenging patients with a levetiracetam combo in levetiracetam-failed patients? Is this used in real-world practice?
How are you treating patients in the focal onset seizure drug-resistant setting post-levetiracetam failure?
What are your thoughts on glutamate inhibitors for focal onset seizure? Approved therapies including topiramate, lamotrigine, carbamazepine also lower glutamate directly and indirectly (via sodium & calcium channel blocking), so is ADX71149/JNJ-40411813's novel positive allosteric modulator (PAM) of metabotropic glutamate receptor 2 (mGlu2) really that unique?
What are your expectations on clinically relevant positive ADX71149/JNJ-40411813 data? Are you looking for >50% seizure reduction through day 28?
Added By: kennyWhat are your thoughts on the ADX71149/JNJ-40411813 phase 2 trial design? Is it designed to adequately capture seizure efficacy and how does the trial design compare to other focal onset seizure trials?
Added By: kennyDo you have experience with Eastern European seizure trial sites and how does the standard of care in focal seizure therapy compare to USA standard-of-care?
Could switching from Eastern European standard of care therapy to trial standard of care, inflate ADX71149/JNJ-40411813 efficacy?
Did the JNJ run the preclin trial in levetiracetam resistant mice?
Added By: kennyAre You Interested In These Questions?
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