EG427 Announces New Preclinical Results from Multiple Studies of EG110A in Neurogenic Detrusor Overactivity (NDO) and Overactive Bladder (OAB)

2024-01-04

基因疗法临床结果临床申请临床研究临床1期

In a non-clinical pharmacology study in an OAB model, EG110A showed similar efficacy and a strong safety profile compared to botulinum toxin A, notably without the increase in post-void residual urine volume, a known adverse reaction in NDO and OAB with botulinum toxin A

In a long-term non-clinical kinetic study, EG110A demonstrated persistent transgene expression in the dorsal root ganglia in animals of at least six months

First-in-human phase 1b/2a trial of non-replicative HSV1-based gene therapy on track to start in H1 2024

Paris, France, January 4, 2023 – EG 427, a biotechnology company leading the development of pinpoint DNA medicines for neurology, based on its unique non-replicative HSV-1 vector platform, today reports positive preclinical results from two studies of its gene therapy product EG110A for the treatment of neurogenic detrusor overactivity (NDO) and overactive bladder (OAB).

In the first non-clinical pharmacology study comparing bladder injections of EG110A to botulinum toxin A in OAB, EG110A showed comparable efficacy, and further showed no increase in post-void residual urine volume. The increase of residual urine volume is known to lead in humans to an increased frequency of urinary infections, that can be difficult to treat in these patients.

In the second study, which evaluated EG110A transgene expression over time in the dorsal root ganglia of treated animals, EG110A demonstrated persistent gene expression out to the final six-month time point. These results strongly support the potential for EG110A to provide long-term relief for patients suffering from NDO and OAB.

“These exciting preclinical results demonstrate that EG 427 is on-track to establish proof of concept for first product, EG110A, in its initial indication, a major step toward validating the potential of our broad platform in neurology" said Philippe Chambon, MD, Chief Executive Officer at EG 427.

These data offer compelling preclinical evidence for proof-of-concept for EG110A in NDO and OAB, with potential significant medical improvement over existing therapies, as one course of treatment could lead to long lasting efficacy without negative impact on residual volume. EG 427 will be filing an Investigational New Drug (IND) application for EG110A in the first quarter of this year.

About EG 427

EG 427 is the second company to bring a non-replicating HSV-1 vector into clinical development, filing an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) in early 2024. It will be the first human trial of such a vector, targeting sensory neuron-based diseases. The product, EG110A, addresses multiple severe bladder diseases, such as neurogenic bladder (NDO) or overactive bladder (OAB), and has the potential to be a major improvement over existing therapies, resulting in better care for patients and lower costs for healthcare systems.

The company’s unique platform delivers pinpoint neurotherapeutics to treat prevalent diseases of the peripheral and central nervous system. Its vectors can achieve focal transduction in specific regions and then selective expression of transgenes in targeted subsets of neurons thanks to the control of sophisticated regulatory elements. With demonstrated clinical safety and possible repeated dosing, the large payload capacity of nrHSV-1 vectors allows either for long-term gene therapy, or all-in-one gene editing approaches.

For more information:

check our website at www.eg427.com

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Contacts:

EG427

Philippe Chambon, M.D., Ph.D.

Founder and CEO

pchambon@eg427.com Global Media Relations

Sophie Baumont

Cohesion Bureau

sophie.baumont@cohesionbureau.com

+33 6 27 74 74 49