EG 427 doses first patient with gene therapy in neurogenic bladder trial

Paris-based startup EG 427 announced that the first patient has been treated in a phase 1b/2a study of EG110A, the company’s lead asset for the treatment of neurogenic detrusor overactivity (NDO) in people with spinal cord injury.

The open-label, dose-escalation study is enrolling 16 adult participants with NDO following spinal cord injury, who have persistent urinary incontinence after standard of care therapy and who perform clean intermittent catheterization on a regular basis. Participants are receiving a single treatment course consisting of multiple intradetrusor injections of EG110A.

EG110A is a novel non-replicative herpes simplex virus 1 (HSV1)-derived vector carrying the sequence of the light chain of the botulinum toxin F (BoNT-F/LC) under the control of a human calcitonin gene related peptide (hCGRP) promoter. The vector platform delivers, with pinpoint precision, highly selective, durable expression of disease modifying transgenes for use in the treatment of peripheral nervous system disorders and beyond.

The approach aims to provide patients with a comprehensive, long-term solution to their bladder management, through a highly selective molecular surgery approach overcoming the significant drawbacks of the current standard of care.

“The treatment of our first patient in our phase 1b/2a study is an important milestone for EG 427. We are looking forward to demonstrating that EG110A has the potential to offer significant improvement over existing therapies in neurogenic detrusor overactivity," said Cornelia Haag-Molkenteller, M.D., Ph.D., EG 427’s chief medical officer. "It paves the way for a broader clinical development of EG110A across other medically important but still underserved pathologies, and the possibility of bringing the potential benefits of genetic medicine to larger disease populations in neuro-urology, urology and neurology.”

Last week, EG 427 announced the successful closing of a $28 million (€27 million) Series B financing round, which it will use to continue to finance a phase 1b/2a study of EG110A through safety and early efficacy results.