Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247241
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2024-01-19
Brief Title:
A Phase 2a Study To Evaluate VMB-100 In Females With Stress Urinary Incontinence
Sponsor:
Versameb AG
Organization:
Versameb AG
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-1s role in regeneratingmaintaining 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
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-1s role in regeneratingmaintaining 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None