EpilepsyGTx, a biotechnology company developing cutting-edge gene therapies to treat refractory epilepsy, and ClearPoint Neuro (“ClearPoint”), a global therapeutics company providing precise navigation and delivery to the brain, today announced a collaboration to support targeted delivery of EPY201, EpilepsyGTx’s lead gene therapy candidate for focal refractory epilepsy (FRE).
Under the agreement, EpilepsyGTx will use the ClearPoint SmartFlow cannula and ClearPoint Neuro Navigation System to administer EPY201 in an upcoming first-in-human Phase 1/2a clinical trial for FRE. ClearPoint’s MRI-guided stereotactic navigation and delivery platform is designed to support sub-millimeter precision in delivery to defined targets within the brain, allowing intraprocedural visualization of delivery to the intended seizure focus. ClearPoint navigation systems are installed in more than 100 active clinical sites worldwide to deliver gene and cell therapies to the central nervous system within preclinical studies, approved clinical trials, and commercial procedures.
Focal epilepsy refers to a group of disorders in which seizures originate in specific parts of the brain. Epilepsy is considered refractory or drug-resistant if it is tolerated and seizures persist after a trial of at least two appropriately selected anti-seizure drugs. FRE affects approximately 10 million patients worldwide, including 2 million patients in the United States, United Kingdom, and European Union. EPY201 is designed to be delivered directly to the seizure focus, with the goal of reducing neuronal hyperexcitability locally while limiting exposure beyond targeted areas in the brain. If successful, this approach would provide patients with a single, minimally invasive option that does not require removal or removal of brain tissue.
Precise delivery to the seizure focus is central to the potential of EPY201 in FRE. ClearPoint’s guided navigation system provides the precision and step-by-step visualization you need as you prepare to assess EPY201 on the First-in-Human exam. We look forward to working with ClearPoint to support the safe and targeted administration of EPY201 to people with focal refractory epilepsy. ”
Nicolas Koebel, CEO of EpilepsyGTx
Jeremy Stigall, ClearPoint Neuro’s Chief Business Officer and General Manager of Biologics and Drug Delivery, said: “EpilepsyGTx is developing a targeted gene therapy approach for focal refractory epilepsy, a serious condition that affects millions of patients. We are pleased to partner with the team as they advance this important program into clinical evaluation.”
