EG 427
The data represents a pivotal milestone and paves the way for an Investigational New Drug (IND) application.
PARIS, FRANCE, November 7, 2023 /EINPresswire.com/ — EG 427, a biotechnology company leading the development of pinpoint DNA medicine solutions based on its unique non-replicative HSV-1 vector platform, today reports positive preclinical results from a dose escalation study of its gene therapy product EG110A for the treatment of neurogenic detrusor overactivity (NDO) and overactive bladder (OAB). The data represents a pivotal milestone and paves the way for an Investigational New Drug (IND) application and initiation of the first clinical study of EG110A in early 2024.
“These new data and the consistency in our results across multiple preclinical studies offers robust evidence of the efficacy and safety of EG110A in relevant animal models. Our market research indicates that current treatments are unsatisfactory with limited efficacy and undesirable side effects. Therefore, EG110A has the potential to fulfill an important unmet need for patients, while providing urologists with a new therapeutic intervention that they find desirable,” said Philippe Chambon, Chief Executive Officer at EG 427.
The latest results obtained in a capsaicin induced rat overactive bladder, measured by a set of cystometry endpoints including micturition frequency, show highly significant decreased sensitivity to irritant of targeted C fibers. The data showed a safety profile no different than control across all doses, including the preservation of voiding efficiency, a key parameter. Thanks to its ability to selectively target sensory neurons of the bladder without affecting motor neurons (used for bladder voiding), EG110A may provide a long-term solution that sidesteps the common side effects of current drugs, such as urinary retention or chronic urinary tract infections. The same functional endpoints measured in these non-clinical studies will be used in the human phase 1b/2a study slated to start in H1 2024, with additional patient reported outcomes. These most recent positive preclinical findings, will later be published in a peer-reviewed setting in greater detail.
Dr. Cornelia Haag-Molkenteller, Chief Medical Officer at EG 427, added, “Neurogenic detrusor overactivity and overactive bladder significantly impair the quality of life for patients despite current therapeutic options. Patients simply require better solutions for long-term management of these chronic and burdensome conditions. These new results from the non-clinical dose ranging study across 3 doses levels, confirm the finding of prior non-clinical pharmacology studies regarding efficacy and the safety profile of EG110A. They allow for the selection of the initial dosing in patients for the first phase 1b/2a study. These pharmacodynamic results set the stage for advancing EG110A into U.S. and European clinical studies.”
The successful completion of the preclinical phase for EG110A is testament to EG 427’s commitment to developing non-replicative HSV vector-based gene therapies as cutting-edge healthcare solutions for local chronic diseases.
Philippe Chambon
EG 427
[email protected]
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