EpilepsyGTx and Viralgen Launch Collaborative Gene Therapy Program for Refractory Epilepsy
EpilepsyGTx, a biotechnology company focused on pioneering gene therapies for refractory epilepsy, and Viralgen, a leading contract development and manufacturing organization (CDMO), have announced a significant collaboration aimed at advancing the research program for EPY201, a gene therapy targeting patients with focal refractory epilepsy (FRE). This partnership seeks to facilitate the initial human trials for EPY201, a treatment designed to directly address the specific areas of the brain where seizures originate.
Approximately 10 million people globally suffer from refractory epilepsy, with around two million of these located in the United States, the United Kingdom, and the European Union. Refractory epilepsy is classified as such when patients have failed to achieve seizure control after trying at least two well-tolerated antiepileptic medications. The condition can significantly impact the quality of life, making effective treatment options essential.
The treatment, EPY201, is designed to be administered directly at the epileptic focus, aiming to reduce neuronal hyperexcitability locally while minimizing exposure to surrounding brain tissue. This innovative approach offers the potential to provide patients with a unique, minimally invasive option that does not require resection or ablation of brain tissue, which is traditionally seen in epilepsy surgeries. If successful, it could lead to significant improvements for patients suffering from medication-resistant epilepsy.
As part of the collaboration, Viralgen will utilize its proprietary Aava™ manufacturing platform to ensure a reliable and efficient production of EPY201. This technology allows for scalable and high-performance production of various AAV serotypes. Viralgen’s manufacturing prowess has already supported the production of over 1,500 AAV batches, laying a strong foundation for the future of EPY201’s development.
The CEO of EpilepsyGTx, Nicolas Koebel, expressed optimism about the collaboration, stating, "Viralgen’s expertise in AAV vector manufacturing and their state-of-the-art platform is crucial as we prepare to move EPY201 towards clinical development. Their established regulatory track record and technical capabilities position them as an excellent manufacturing partner in our mission to bring innovative gene therapy closer to clinical practice."
Additionally, Jimmy Vanhove, CEO of Viralgen, emphasized the importance of this partnership, saying, "We are proud to partner with EpilepsyGTx on this significant program. Our Aava platform is engineered specifically for the efficient scaling of AAV programs, and our manufacturing expertise allows us to support EpilepsyGTx in rapidly advancing EPY201 to patients with focal refractory epilepsy."
Launched from groundbreaking research at the University College London’s Institute of Neurology, EpilepsyGTx has garnered substantial evidence of potential anticonvulsant activity and tolerability from preclinical trials in translational models of FRE. The company’s primary program, EPY201, uses a modified form of the potassium channel Kv1.1 and is set to enter early-stage human clinical trials in the first half of 2027. This therapeutic strategy represents a transformative approach that could provide effective seizure control without the need for invasive surgical procedures.
As we look forward to the continued development of EPY201, both EpilepsyGTx and Viralgen are committed to bringing this groundbreaking therapy to the forefront of treatment for those suffering from refractory epilepsy. This collaboration not only marks a step forward in the realm of gene therapy but also promises hope to millions seeking effective treatment solutions.