EpilepsyGTx has announced it will partner with ClearPoint Neuro to support the targeted delivery of its lead investigational gene therapy, EPY201, as the UK-based biotech prepares to enter first-in-human clinical trials for focal refractory epilepsy (FRE).
Under the agreement, EpilepsyGTx will use ClearPoint's SmartFlow Cannula and Neuro Navigation System to administer EPY201 during its planned Phase I/IIa trial.
The MRI-guided stereotactic platform is designed to enable sub-millimetre accuracy when delivering therapies directly into defined regions of the brain, while allowing clinicians to visualise delivery in real time.
The collaboration reflects the importance of precision delivery technologies in central nervous system (CNS) gene therapy manufacturing and development, where accurate placement of viral vector-based medicines is critical to maximising efficacy while also minimising off-target effects.
EpilepsyGTx's lead investigational gene therapy, EPY201, is an AAV-based gene therapy designed to reduce neuronal hyperexcitability by delivering treatment directly to the seizure focus.
Unlike conventional anti-seizure medicines, which require lifelong administration, the investigational therapy aims to provide a one-time, minimally invasive treatment without removing or ablating brain tissue.
The partnership follows on from EpilepsyGTx's $33m Series A financing announced in late 2025, which was raised to advance EPY201 into first-in-human clinical studies.
"Accurate delivery to the seizure focus is central to the potential of EPY201 in FRE," said Nicolas Koebel, CEO of EpilepsyGTx.
ClearPoint's guided navigation system provides the precision and intraprocedural visualisation we need as we prepare to evaluate EPY201 in first-in-human trials.
Jeremy Stigall, Chief Business Officer and General Manager of Biologics and Drug Delivery at ClearPoint Neuro, added: "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.
