EG 427 Bags US FDA Nod To Initiate phase 1b/2a study of Gene Therapy

EG 427, a biotech firm that is leading the development of pinpoint DNA medicines for common neurology ailments using its unique non-replicative HSV-1 vector platform, announces that it gained Investigational New Drug (IND) authorization from the US Food and Drug Administration (FDA) for EG110A, a gene therapy for the treatment of Neurogenic Detrusor Overactivity (NDO) in Spinal Cord Injury (SCI) patients. The phase 1b/2a study is being conducted at two leading US institutions.

EG110A is a non-replicating HSV-1 vector that has been created to selectively mute the signals of important bladder sensory neurons that cause bladder muscle overactivity, while protecting motor neurons and maintaining normal bladder function.

“NDO is a serious bladder condition, for whom treatment options are limited,” said Cornelia Haag-Molkenteller, MD, PhD, chief medical officer of EG 427. “Preclinical results have shown clear evidence that suggests EG110A could offer significant medical improvement over existing therapies. These data have shown that one course of treatment with EG110A can potentially lead to long-lasting efficacy without affecting the bladder function. We are excited to move this promising product into the clinic.”

According to a study published in The Lancet Neurology3, neurological illnesses affect 3 billion individuals, or around one-third of the world's population, and their medical needs are unmet. EG 427 is developing a pipeline of medications to treat these disorders using its proprietary nonreplicative HSV vector platform, which is especially designed to target neural cells in a safe and long-lasting manner.