A Phase 2a Study To Evaluate VMB-100 In Females With Stress Urinary Incontinence
- Registration Number
- NCT06247241
- Lead Sponsor
- Versameb AG
- 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).
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description VMB-100 administration VMB-100 intrasphincteric injection of VMB-100 in the urethra sphincter
- Primary Outcome Measures
Name Time Method Tolerability of VMB-100 injection, pain periprocedurally measurement of pain by Visual Analogue Scale (0-10, where 0 is no pain and 10 is the worst pain)
Vital signs following VMB-100 administration from baseline/preinjection through study completion (est average 1 year) heart rate, blood pressure, respiratory rate, body temperature
12-lead ECG following VMB-100 administration from baseline/preinjection through study completion (est average 1 year) P-wave, QRS complex, QTc prolongation
Safety following VMB-100 administration immediately after the intervention through study completion (est average 1 year) Adverse Events of Special Interest (AESIs)
Clinical laboratory measurements following VMB-100 administration from baseline/preinjection through study completion (est average 1 year) change in urinalysis (proportion of subjects)
- Secondary Outcome Measures
Name Time Method