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

Versameb

Status and phase

Begins enrollment in 2 months

Phase 2

Conditions

Stress Urinary Incontinence

Treatments

Drug: VMB-100

Study type

Interventional

Funder types

Industry

Identifiers

NCT06247241

VMB-100-U222

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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