Case Study: GRIN Therapeutics achieves personalized pediatric epilepsy dosing with Certara PBPK modeling

Enabling Personalized Therapy with PBPK Modeling for Pediatric Epilepsy

GRIN Therapeutics, an affiliate of Neurvati Neurosciences, faced the challenge of determining safe and effective doses for a vulnerable pediatric patient population with GRIN-related neurodevelopmental disorder for their drug radiprodil. They needed to ensure the doses achieved exposures required for efficacy while staying within predefined safety limits, all without delaying the start of their initial efficacy study. They partnered with Certara and utilized its Simcyp PBPK Simulator and modeling services to address this.

Certara repurposed an existing PBPK model for radiprodil to create an individualized dosing approach. Their global team used the model to perform real-time Virtual Twin simulations, incorporating individual patient exposure data to predict the next dose escalation for each patient within 24 hours. This solution allowed GRIN Therapeutics to personalize therapy, accelerate development, and gain regulatory confidence. The model enabled the selection of doses with an optimal safety and efficacy profile, supporting the program's advancement toward a pivotal Phase 3 trial.

GRIN Therapeutics

Pierandrea Muglia

Founder