EG110A Gene Therapy for Overactive Bladder

Not yet recruiting at 3 trial locations

Overseen By Sandrine Zourbas, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: EG 427

Disqualifiers: Other gene therapy, Uncontrolled illness, Substance abuse

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on the long-term safety and effectiveness of a gene therapy treatment called EG110A for individuals with overactive bladder, a condition causing a strong, sudden urge to urinate. The study aims to assess how well this treatment is tolerated and identify any side effects over five years. It specifically targets those who have already participated in a previous study involving at least one dose of EG110A. Participants should not be involved in any other gene therapy studies and must not have current health issues that might interfere with the trial. As a Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that EG110A is likely to be safe for humans?

Research has shown that EG110A, a gene therapy for overactive bladder, demonstrates promising safety results. In one study, patients experienced over an 88% reduction in episodes of urinary incontinence. Importantly, this treatment was well-tolerated, causing no systemic side effects. Another study found similar results, with more than an 80% reduction in symptoms. This evidence suggests that EG110A is generally safe for participants, although ongoing studies continue to assess long-term effects. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for overactive bladder?

Unlike standard treatments for overactive bladder, which often involve medications that relax the bladder muscle or procedures like nerve stimulation, EG110A is a gene therapy. This innovative approach works by potentially altering the genes responsible for bladder control, aiming to provide a long-lasting solution rather than just temporary relief. Researchers are excited about EG110A because it targets the underlying causes of bladder dysfunction at the genetic level, which could offer significant improvements in quality of life and reduced symptoms for patients.

What evidence suggests that EG110A might be an effective treatment for overactive bladder?

Research has shown that EG110A, a gene therapy, holds great promise for treating overactive bladder. In previous studies, EG110A reduced episodes of urinary incontinence by more than 80%. Even at the lowest dose, it decreased these episodes by over 88% after just 12 weeks. This treatment alters genes to improve bladder control. These results suggest that EG110A could effectively manage symptoms of overactive bladder. Participants in this trial will receive EG110A, regardless of dose, to further evaluate its effectiveness. ^{1 3 6 7 8}

Who Is on the Research Team?

Cornelia Haag-Molkenteller, MD

Principal Investigator

EG 427

Are You a Good Fit for This Trial?

This trial is for individuals who have previously received at least one dose of EG110A in an earlier study, targeting those with overactive bladder and spinal cord injury. Participants will be monitored long-term to assess the effects and dosage tolerance of EG110A.

Inclusion Criteria

All participants who received at least one dose/injection of EG110A in Study EG110A-001-01 and have prematurely discontinued or completed that study.

Exclusion Criteria

Participant plans to participate in another investigational gene therapy study

Participant has an uncontrolled intercurrent illness, any disorder, or current substance abuse that would limit compliance with study requirements in the opinion of the investigator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Long-term Follow-up

Participants are monitored for safety, long-term efficacy, and adverse events after receiving EG110A

5 years

Regular visits as per study protocol

Data Collection

Collection of patient-reported outcomes and urodynamics data

5 years

What Are the Treatments Tested in This Trial?

Interventions

• EG110A

Trial Overview The focus is on the long-term follow-up of patients who were administered EG110A, a gene therapy derived from Herpes Simplex Virus 1. The study aims to understand its tolerability, potential side effects, and effective dosing over a five-year period.

How Is the Trial Designed?

Group I: Patients who received EG110A in a clinical study, regardless of dose Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

EG 427

Lead Sponsor

Trials

1

Recruited

20+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07227285?term=%22gene+therapy%22+OR+%22gene+transfer%22+OR+%22virus+delivery%22

Long-term Follow-up Study of Patients Who Received ... The aim of this study is to continue following participants who have received EG110A during five years to know how it is tolerated in humans, ...

2. eg427.com eg427.com/EG-427-Announces-Positive-Preclinical-Results-from-EG110A-IND-Enabling-Study-in-Neurogenic-Detrusor-Overactivity-and-Overactive-Bladder.html

EG 427 Announces Positive Preclinical Results from ... EG 427 today reports positive preclinical results from a dose escalation study of its gene therapy product EG110A for the treatment of neurogenic detrusor ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/eg-427-eg110a-urinary-incontinence-phase-ib-iia-trial/

EG 427's EG110A reduces urinary incontinence in Phase ... French biotech EG 427 has had success with its urinary incontinence DNA therapy, EG110A, showing a more than 80% reduction in episodes.

4. urologytimes.com urologytimes.com/view/fda-grants-fast-track-designation-to-eg110a-for-neurogenic-bladder

FDA grants fast track designation to EG110A for ... 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 ...

5. insideprecisionmedicine.com insideprecisionmedicine.com/topics/precision-medicine/gene-therapy-targeting-incontinence-shows-promise-in-patients/

Gene Therapy Targeting Incontinence Shows Promise in ... A gene therapy to treat urinary incontinence associated with spinal cord injury reduced episodes by 88% at the lowest dose after 12 weeks.

6. eg427.com eg427.com/web/DATA/20251001_EG%20427_PR_First%20Cohort%20Data_EN_Vf2.pdf

EG 427 Announces Compelling Initial Topline Clinical ... Over 88% reduction in urinary incontinence episodes achieved in low dose cohort at 12 weeks. • Good tolerability with no systemic side ...

7. biospace.com biospace.com/press-releases/eg-427-receives-u-s-fda-fast-track-designation-for-eg110a-dna-medicine-in-neurogenic-bladder-patients

EG 427 Receives U.S. FDA Fast Track Designation for ... Top-line data showed for the first time in a chronic neuro-urological condition that treatment with our DNA medicine EG110A reduced incontinence ...

8. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/milestone-reached-first-patient-treated-with-eg110a-for-neurogenic-bladder/

First Patient Treated with EG110A for Neurogenic Bladder The potential of EG110A to selectively target the underlying cause of NDO offers a new avenue for improved patient outcomes, potentially ...