FDA grants fast track designation to EG110A for neurogenic bladder

The FDA has granted fast track designation to EG110A, a nonreplicative HSV-1 vector for the management of neurogenic detrusor overactivity (NDO), EG 427 announced in a news release.¹

According to the company, EG110A is “designed to selectively silence the signals from type C sensory neurons responsible for the bladder muscle overactivity, [while] preserving other bladder controls.” The agent is the first DNA medicine to selectively target a specific subtype of sensory neurons at the local level, according to EG 427.

Fast track designation is awarded to investigational drugs that have the potential to address unmet needs in serious or life-threatening conditions. With this designation, the development program for EG110A can benefit from priority review and accelerated approval, if relevant criteria are met.

“The FDA's decision to grant fast track designation to EG110A demonstrates the urgent need for more effective therapies for individuals living with neurogenic detrusor overactivity,” said Philippe Chambon, MD, PhD, chief executive officer at EG 427, in the news release.¹

This announcement follows positive top-line data from the company’s phase 1b/2a clinical trial (NCT06596291) of EG110A in patients with NDO following a spinal cord injury.² In total, the trial plans to enroll 16 adult patients who have persistent urinary incontinence following standard-of-care therapy and who regularly perform clean intermittent catheterization.

Patients in the study will receive a single treatment course of multiple intradetrusor injections of EG110A. The agent is being assessed across 3 dose levels (low, middle, and high).³ The primary end point is the incidence of treatment-emergent adverse events. Secondary end points include changes from baseline in urodynamic variables at weeks 12 and 52 as well as changes from baseline in 7-day bladder diary measures at weeks 12 and 52.

Overall, interim data from the study showed that at the lowest dose, EG110A was associated with a more than 88% reduction in the incidence of urinary incontinence episodes by week 12. Treatment effect was clearly established as early as week 4.

The agent was also well tolerated across all patient groups, with no systemic adverse effects reported.

Chambon noted in a prior news release,² “As these [findings] validate a biological mechanism underpinning multiple diseases driven by type C sensory neuron activity, we can now envision developing EG110A more broadly in clinical studies in multiple underserved pathologies, including in the pain field. These initial clinical results also validate EG 427’s HERMES platform, a proprietary nonreplicative HSV vector system designed for precise DNA delivery, without systemic exposure.”

Full preliminary results from the study will be presented at the 2025 Cell & Gene Meeting on the Mesa conference in Phoenix, Arizona.

“We welcome the opportunity to work more closely with the FDA as we advance EG110A through clinical development, building on the very promising clinical results we announced last week,” Chambon concluded in the news release.¹ “Top-line data showed for the first time in a chronic neuro-urological condition that treatment with our DNA medicine EG110A reduced incontinence episodes by over 88% by the predetermined 12-week time point.”

REFERENCES

1. EG 427 receives U.S. FDA Fast Track Designation for EG110A DNA medicine in neurogenic bladder patients. News release. EG 427. October 6, 2025. Accessed October 6, 2025. https://www.eg427.com/EG-427-Receives-U-S--FDA-Fast-Track-Designation-for-EG110A-DNA-Medicine-in-Neurogenic-Bladder-Patients.html

2. EG 427 announces compelling initial topline clinical results with EG110A DNA medicine in neurogenic bladder patients. News release. EG 427. October 2, 2025. Accessed October 6, 2025. https://www.eg427.com/EG-427-Announces-Compelling-Initial-Topline-Clinical-Results-with-EG110A-DNA-Medicine-in-Neurogenic-Bladder-Patients.html

3. Dose escalation study of EG110A, administered by intradetrusor injections to adults with neurogenic detrusor overactivity-related incontinence following spinal cord injury who regularly perform clean intermittent catheterization. ClinicalTrials.gov. Updated July 18, 2025. Accessed October 6, 2025. https://clinicaltrials.gov/study/NCT06596291