First gene therapy for bladder condition enters clinical study


Biotechnology company EG 427 has revealed plans to start a Phase Ib/IIa clinical study in neurogenic detrusor overactivity (NDO), following Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA).

NDO is a severe bladder condition affecting patients living with spinal cord injury, multiple sclerosis, Parkinson’s disease and other neurological disorders.

The gene therapy EG110A is a non-replicating HSV-1 vector that has been designed to selectively silence the signals of key bladder sensory neurons responsible for the bladder muscle overactivity, whilst preserving motor neuron and retaining normal bladder function.

The European Association of Urology recently estimated that incontinence caused by NDO and other indications represents a growing economic burden of over €40 billion per year in Europe.

“NDO is a serious bladder condition, for whom treatment options are limited,” said Cornelia Haag-Molkenteller, 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.”

EG 427 is the second company to bring a non-replicating HSV-1 (nrHSV-1) vector into clinical development but will be the first human trial of such a vector targeting sensory neuron-based diseases.

“This IND clearance for our first product is a major milestone for EG 427, opening the way for clinical development of EG110A across a series of medically important but neglected neuro-urology pathologies. It is a step forward in bringing the potential benefits of gene therapy to large disease populations in neurology. Non-replicative HSV-1 vectors are truly unique in their ability to deliver therapeutic solutions in a potentially safe, redosable and cost-effective way,” said Philippe Chambon, Chief Executive Officer at EG 427.

Diana Spencer, Senior Digital Content Editor, DDW

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