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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06247241
Other study ID # VMB-100-U222
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date April 2024
Est. completion date November 2027

Study information

Verified date January 2024
Source Versameb AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date November 2027
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility Main inclusion criteria: - 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. Main exclusion criteria: - 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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Versameb AG PPD

Outcome

Type Measure Description Time frame Safety issue
Other Efficacy; effect on incontinence event frequency bladder diary will record number of incontinence events for 7 days prior to each visit from baseline/preinjection through study completion (est average 1 year)
Other Efficacy; effect on patient assessment of effect patient reported outcomes questionnaire Patient Global Impression of Severity (PGI-S) for stress urinary incontinence from baseline/preinjection through study completion (est average 1 year)
Other Efficacy; effect on patient assessment of effect patient reported outcomes questionnaire Patient Global Impression of Improvement (PGI-I ) for stress urinary incontinence from baseline/preinjection through study completion (est average 1 year)
Other Efficacy; effect on patient assessment of effect patient reported outcomes questionnaire; International Consultation on Incontinence Questionnaire (ICIQ) from baseline/preinjection through study completion (est average 1 year)
Other Efficacy; effect on patient assessment of effect patient reported outcomes questionnaire Kings Health Questionnaire (KHQ) from baseline/preinjection through study completion (est average 1 year)
Other Pharmacodynamic evaluation; morphologic changes to the urethra sphincter using transvaginal ultrasound change in sphincter thickness, measured in millimeters from baseline/preinjection to week 24
Primary Safety following VMB-100 administration Adverse Events (AEs) from baseline/preinjection through study completion (est average 1 year)
Primary Safety following VMB-100 administration Treatment Emergent Adverse Events (TEAEs) immediately after the intervention through study completion (est average 1 year)
Primary Safety following VMB-100 administration Adverse Events of Special Interest (AESIs) immediately after the intervention through study completion (est average 1 year)
Primary 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
Primary Vital signs following VMB-100 administration heart rate, blood pressure, respiratory rate, body temperature from baseline/preinjection through study completion (est average 1 year)
Primary 12-lead ECG following VMB-100 administration P-wave, QRS complex, QTc prolongation from baseline/preinjection through study completion (est average 1 year)
Primary Clinical laboratory measurements following VMB-100 administration change in hematology parameters ( proportion of subjects) from baseline/preinjection through study completion (est average 1 year)
Primary Clinical laboratory measurements following VMB-100 administration change in biochemistry parameters (proportion of subjects) from baseline/preinjection through study completion (est average 1 year)
Primary Clinical laboratory measurements following VMB-100 administration change in urinalysis (proportion of subjects) from baseline/preinjection through study completion (est average 1 year)
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