#USA #gene therapy #San Sebastián #Viralgen #EpilepsyGTx

Advancing Epilepsy Treatment through Innovative Gene Therapy

In a significant development for epilepsy treatment, EpilepsyGTx, a biotechnology company focused on gene therapies for refractory epilepsy, has announced a collaboration with Viralgen, a leading Contract Development and Manufacturing Organization (CDMO). This partnership is aimed at advancing the production of EPY201, an innovative investigational gene therapy designed to treat patients suffering from focal refractory epilepsy (FRE). This collaboration comes ahead of the anticipated first-in-human clinical trials set to commence in 2027.

Focal epilepsy refers to a group of disorders where seizures originate from a specific region in the brain. When conventional treatment options—specifically two or more antiseizure medications—fail to manage the condition effectively, epilepsy is classified as refractory or pharmacoresistant. This impairs daily life for approximately 10 million people worldwide, including 2 million in the US, UK, and EU alone.

The focus of this innovative treatment, EPY201, lies in its delivery methods and targeting capabilities. The therapy is developed to be directly administered at the seizure focus, aiming to reduce excessive neuronal activity without significantly impacting the surrounding brain tissue. Provided that the method is successful, it could offer a much-needed minimally invasive solution that avoids traditional surgical interventions like resection.

Nicolas Koebel, the CEO of EpilepsyGTx, has emphasized the importance of Viralgen’s expertise in AAV manufacturing as a pivotal element in progressing EPY201 toward clinical trials. He remarked, “Viralgen's platform and infrastructure are critical for facilitating our advancement into the clinical development of this promising gene therapy.”

Jimmy Vanhove, the CEO at Viralgen, echoed Koebel's sentiments, expressing pride in their partnership with EpilepsyGTx. He stated, “Our Aava™ platform is specifically designed to support scalable AAV programmes efficiently, ensuring that we can assist in the swift development of EPY201 for those with focal refractory epilepsy.”

The Aava™ manufacturing platform is notable for its efficiency and reliability, supporting over 1,500 AAV batches. This technology is anticipated to be key in delivering the necessary production levels as development progresses.

As detailed information about both companies reveals, EpilepsyGTx was founded in 2021, drawing on pioneering research from University College London. The firm aims to provide patients with the prospect of seizure freedom through a groundbreaking single procedure approach. On the flip side, Viralgen has been operational since 2017, creating innovative solutions specializing exclusively in AAV-based cell and gene therapies. They leverage state-of-the-art facilities in San Sebastián, Spain, which are compliant with cGMP regulations and equipped to enable significant production capabilities for their clients.

Looking ahead, the collaborative efforts between EpilepsyGTx and Viralgen not only illuminate a new horizon for epilepsy treatment but also signify critical advancements in the field of gene therapy. For millions living with drug-resistant epilepsy, EPY201 could pave the way for groundbreaking treatment options, enhancing both quality of life and the hope for recovery. This partnership represents a vital step toward a future where innovative therapies can radically improve patient outcomes in the realm of neurological disorders.