A Phase 2a Study To Evaluate VMB-100 In Females With Stress Urinary Incontinence

NCT06247241 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: VMB-100-U222
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study drug VMB-100 is an mRNA encoding for IGF-1. It is administered by injection into the urethra sphincter, and taken up by the muscle cells. The IGF-1 acts to promote muscle regeneration in the sphincter, which is expected to improve the function of the sphincter and thereby alleviate incontinence (urinary leakage).

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (9)

• Safety following VMB-100 administration

  Adverse Events (AEs)

  from baseline/preinjection through study completion (est average 1 year)

• Safety following VMB-100 administration

  Treatment Emergent Adverse Events (TEAEs)

  immediately after the intervention through study completion (est average 1 year)

• Safety following VMB-100 administration

  Adverse Events of Special Interest (AESIs)

  immediately after the intervention through study completion (est average 1 year)

• Tolerability of VMB-100 injection, pain

  measurement of pain by Visual Analogue Scale (0-10, where 0 is no pain and 10 is the worst pain)

  periprocedurally

• Vital signs following VMB-100 administration

  heart rate, blood pressure, respiratory rate, body temperature

  from baseline/preinjection through study completion (est average 1 year)

• 12-lead ECG following VMB-100 administration

  P-wave, QRS complex, QTc prolongation

  from baseline/preinjection through study completion (est average 1 year)

• Clinical laboratory measurements following VMB-100 administration

  change in hematology parameters ( proportion of subjects)

  from baseline/preinjection through study completion (est average 1 year)

• Clinical laboratory measurements following VMB-100 administration

  change in biochemistry parameters (proportion of subjects)

  from baseline/preinjection through study completion (est average 1 year)

• Clinical laboratory measurements following VMB-100 administration

  change in urinalysis (proportion of subjects)

  from baseline/preinjection through study completion (est average 1 year)

Other Outcomes (6)

• Efficacy; effect on incontinence event frequency

  from baseline/preinjection through study completion (est average 1 year)

• Efficacy; effect on patient assessment of effect

  from baseline/preinjection through study completion (est average 1 year)

• Efficacy; effect on patient assessment of effect

  from baseline/preinjection through study completion (est average 1 year)

Study Arms (1)

VMB-100 administration

EXPERIMENTAL

intrasphincteric injection of VMB-100 in the urethra sphincter

Drug: VMB-100

Interventions

VMB-100 DRUG

VMB-100 is administered as intrasphincteric injection in the urethra sphincter

VMB-100 administration

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pre- or peri-menopausal female subject between 18 and 55 years of age
• Body mass index (BMI) of 19 to 35 kg/m2
• Active SUI of moderate severity for at least 6 consecutive months documented in medical history
• Refractory to standard of care measures
• Must not be pregnant, lactating, or actively trying to become pregnant.

You may not qualify if:

• Any concurrent condition or any clinically significant abnormality at Screening which in the opinion of the Investigator may affect the interpretation of safety or efficacy data or which otherwise contradicts participation in a clinical study with VMB-100
• Unwilling to undergo transvaginal sonography or cystoscopy
• Urodynamic detrusor overactivity
• History of urinary urge incontinence of neurogenic etiology.
• History of or planning for pelvic radiation.
• History of use of any bulking agent or Botox to treat SUI in the past 12 month.
• History of urethral sling, anterior prolapse repair, and/or other SUI procedures or surgical procedures affecting continence.
• Taking any medications that are known to have an effect on urinary continence or medications that may exacerbate incontinence

Sponsors & Collaborators

• Versameb AG: lead
• PPD Development, LP: collaborator

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single and multiple ascending dose

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 7, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: December 5, 2025

Record last verified: 2025-03