NCT06247241

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

A Phase 2a, Open-Label, First-In-Human, Two-Part, Single And Multiple Ascending Dose Study To Evaluate The Safety, Tolerability, And Efficacy Of VMB-100 In Female Subjects With Moderate Stress Urinary Incontinence

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Versameb AG · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Versameb AG (Sponsor) is developing VMB-100 for the treatment of stress urinary incontinence (SUI), and mixed urinary incontinence (MUI) with a predominant stress component, a common and debilitating condition that significantly impacts quality of life, and for which there are currently no approved pharmacological therapies available in the US. The drug substance of VMB-100 is a mRNA encoding human insulin-like growth factor-1 (IGF-1). VMB-100 is administered as a transurethral injection into the urinary sphincter muscle. The injected mRNA is taken up by the muscle tissue cells and serves as a template for the translation of the protein IGF-1. Insulin-like growth factor-1 is secreted into the extracellular space, where it acts to promote muscle regeneration of the urinary sphincter via auto- and paracrine activation of downstream pathways in a localized manner. The current understanding in urology is that reduced maximum urethral closure pressure (MUCP) is the factor most strongly associated with SUI. This implies that improving function of the closure muscles would have therapeutic merit in both SUI as well as MUI with a predominant stress component. No treatment which restores the physiology (regenerates the urinary sphincter muscle) is currently available. Given IGF-1's role in regenerating/maintaining muscle tissue women with SUI may benefit from a localized increase in IGF-1 levels in the urinary sphincter to regenerate muscle and restore sphincter function, thus alleviating the incontinence.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DRUG	VMB-100	VMB-100 is administered as intrasphincteric injection in the urethra sphincter

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-11-01
• Completion: 2029-04-01
• First posted: 2024-02-07
• Last updated: 2025-12-05

Regulatory

• FDA-regulated drug study