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

First-In-Human Phase 1b/2a Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adult Participants With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization

This is a first-in-human, Phase 1b/2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity (NDO)-related incontinence following Spinal Cord Injury (SCI), who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization (CIC) on a regular basis.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Neurogenic Detrusor Overactivity
• Intervention / Treatment: Drug: EG110A

Detailed Description

This first-in-human clinical study, performed in SCI participants with Urinary Incontinence (UI) due to NDO and an inadequate response to current therapy, will evaluate the safety and tolerability of EG110A, and explore the potential doses for further clinical development. The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Sandrine Zourbas, Ph.D.; Phone Number: 33 (0)6 25 62 28 02; Email: szourbas@eg427.com
• Study Contact Backup: Name: Cornelia Haag-Molkenteller, MD; Email: Cornelia@eg427.com

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Recruiting
      • Rancho Los Amigos National Rehabilitation Center
      • Contact: Evgeniy Kreydin, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Withdrawn
      • University of Michigan Rogel Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Sidney Kimmel Medical College
      • Contact: Patrick Shenot, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • UTHealth Houston / TIRR Memorial Hermann
      • Contact: Argyrios Stampas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

1. Participant has stable supra-sacral traumatic SCI with American Spinal Injury Association (ASIA) Impairment Scale grade A, B, C, D or E which occurred at least 12 months before Screening.
2. Participant has UI due to urodynamically-confirmed NDO for at least 3 months prior to Screening.

3. Participant has:

   1. been treated for NDO for at least 3 months prior to Screening with an adequate course of oral pharmacotherapy(ies) and/or has had intolerable side-effects and/or exhibited an inadequate response in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week despite consistent use of the therapy. Participant does not wish to proceed to BoNT/A treatment, and their next step would be surgical intervention.

      OR

   2. had an inadequate response to BoNT/A treatment in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week, and the last BoNT/A treatment for their NDO was at least 6 months prior to screening. Treatment with BoNT/A was not started more than 7 years ago, and their next step would be surgical intervention.

Main Exclusion Criteria:

1. Participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI.
2. Participant with active oral or genital herpes lesion. If the participant has an active oral or genital herpes infection this needs to be treated and healed first. The participant may be rescreened once the lesion has fully healed (at least 4 weeks after the lesion has healed).
3. Participant had cancer therapy or radiotherapy ≤ 4 weeks prior to Screening and has toxicities/AEs attributable to previously administered cancer therapies that have not resolved or stabilized.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EG110A (low dose); Patients who Received EG110A (low dose)	Drug: EG110A; Participants treated with EG110A
Experimental: EG110A (Middle Dose); Patients who Received EG110A (middle dose)	Drug: EG110A; Participants treated with EG110A
Experimental: EG110A (High Dose); Patients who Received EG110A (high dose)	Drug: EG110A; Participants treated with EG110A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	Any participant who has a reported treatment-emergent adverse events (TEAEs)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urodynamic variables: changes at Weeks 12 and 52 compared to baseline	Changes in urodynamic variables will be assessed at Weeks 12 and 52.	1 year
Bladder Diary measures: changes in 7 days' mean daily episodes at Weeks 12 and 52 compared to baseline	7 day bladder diary with recording of urinary incontinence episodes, daily catheterization rates, and volume per catheterization.	1 year

Collaborators and Investigators

• Sponsor: EG 427
• Collaborators: Congressionally Directed Medical Research Programs
• Investigators: Study Director: Cornelia Haag-Molkenteller, MD, EG 427

Publications and helpful links

Helpful Links

• Learn more about the clinical study EG110A-001-01

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: EG110A-001-01; HT94252510505_CDMRP (Other Grant/Funding Number: US Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No