Expert Interview
Analyzing the Phase II RADIANT trial results for vormatrigine (PRAX-628) in focal onset seizures from Praxis Precision Medicines
Ticker(s): PRAXInstitution: Raleigh Neurology Associates
- Practicing Neurologist and Medical director at WakeMed Neurodiagnostic Laboratories
- Manages 150 patients with focal onset seizures
- Triple board certified neurologist with sub speciality training and clinical interest in neurophysiology
In the RADIANT trial, 22% of patients achieved complete seizure elimination in the last 28 days of treatment. How clinically meaningful is this level of seizure freedom compared to what is typically observed with currently available anti-seizure medications?
Added By: slingshot_insightsThe study showed that over 54% of patients achieved at least a 50% reduction in seizures within the first week, with benefits sustained over the 8-week treatment period. How important is this rapid onset of action for patients and clinicians managing focal epilepsy?
Added By: slingshot_insightsThe median seizure reduction of 56.3% is strong for a Phase II trial. How should we interpret this result in the context of efficacy benchmarks set by other sodium channel modulators like cenobamate or perampanel?
Added By: slingshot_insightsGiven that benefits were maintained across the 8-week treatment window, what signals do you look for in Phase II data to assess whether seizure control is likely to remain durable in longer Phase III or real-world use?
Added By: slingshot_insightsThe company noted that vormatrigine was well-tolerated. From your perspective, how critical is tolerability when positioning a potential first-line ASM, given that many patients discontinue current therapies due to side effects rather than lack of efficacy?
Added By: slingshot_insightsVormatrigine acts by selectively blocking hyperexcitable states of sodium channels. How might this mechanism translate into a different efficacy or tolerability profile compared to other sodium channel blockers used in epilepsy?
Added By: slingshot_insightsDespite more than 20 approved seizure drugs, 20–40% of patients with focal onset seizures remain uncontrolled. What gaps do you see vormatrigine potentially filling, and how could it realistically change treatment sequencing if Phase III results are positive?
Added By: slingshot_insightsPraxis plans to advance into the pivotal Phase III POWER1 and POWER2 trials. Based on the RADIANT data, what would you consider the key endpoints, trial designs, or patient subgroups that will be most important to validate vormatrigine’s role in the epilepsy landscape?
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