EpilepsyGTx has partnered with ClearPoint Neuro to enable targeted delivery of its lead gene therapy candidate, EPY201, ahead of first‑in‑human phase 1/2a trials in focal refractory epilepsy.
EpilepsyGTx will use the ClearPoint SmartFlow Cannula and ClearPoint Neuro Navigation system to administer EPY201 directly into the seizure focus.
The MRI‑guided platform provides sub‑millimetric accuracy and real‑time visualisation of delivery to defined targets in the brain. ClearPoint’s navigation system is installed in more than 100 clinical sites worldwide for gene and cell therapy procedures across preclinical studies, approved trials and commercial use.
Focal epilepsy describes disorders in which seizures originate from a specific region of the brain. When seizures persist despite trials of at least two tolerated and appropriately chosen antiseizure medicines, the condition is considered refractory.
Focal refractory epilepsy affects around 10 million people globally, including two million across the US, UK and EU. EPY201 is designed for direct administration into the seizure focus to reduce neuronal hyperexcitability locally while limiting exposure beyond the target region. If successful, it could offer a single, minimally invasive option that avoids resection or ablation of brain tissue.
Nicolas Koebel, Chief Executive Officer of EpilepsyGTx, commented: “Accurate delivery to the seizure focus is central to the potential of EPY201 in FRE. ClearPoint’s guided navigation system provides the precision and intraprocedural visualisation we need as we prepare to evaluate EPY201 in first-in-human trials.”
He added: “We look forward to working with ClearPoint to support safe, targeted administration of EPY201 for people living with focal refractory epilepsy.”
Jeremy Stigall, Chief Business Officer & General Manager of Biologics and Drug Delivery at ClearPoint Neuro, stated: “EpilepsyGTx is developing a targeted gene therapy approach for focal refractory epilepsy, a devastating condition affecting millions of patients. We are pleased to partner with them as the team advances this important programme into clinical evaluation.”
