Versameb: FDA clearance for stress urinary incontinence investigational new drug

Following this clearance, Versameb plans to launch a Phase 2a open label, first-in-human dose ascending study in the first half of 2024. The study will evaluate the safety, tolerability, and efficacy of VMB-100 in female subjects with stress urinary incontinence, a highly common condition resulting in involuntary leakage of urine due to a weakened urinary sphincter muscle.

“The IND clearance by the FDA represents a significant milestone for the VMB-100 development program and for Versameb,” said Klaas Zuideveld, Chief Executive Officer of Versameb AG. “This brings us a step closer to providing an effective therapeutic option to patients suffering from SUI. Our proprietary VERSagile platform is uniquely designed to improve potency of mRNA therapeutics and we believe VMB-100 can potentially become a game changer for SUI treatment. We look forward to initiating this trial in the first half of 2024 to evaluate the potential clinical benefits of VMB-100 in SUI.”

“Stress urinary incontinence significantly impacts the quality of life of millions of women globally and is a major unmet medical need with no approved therapeutics available currently,” said Professor Roger Dmochowski, Chief Medical Officer of Versameb AG. “IGF-1 plays a key role in promoting muscle regeneration and re-establishment of muscle function. We believe VMB-100 has the potential to fill the current therapeutic gap as a first-in-class mRNA therapy that can restore muscle function and thereby effectively treat incontinence.”

About VMB-100
VMB-100 is an intramuscularly locally delivered, sequence engineered messenger ribonucleic acid (mRNA) encoding for human insulin-like growth factor-1 (IGF-1) under investigation for the treatment of stress urinary incontinence (SUI). VMB-100 has the potential to become first-and best-in-class in sustained muscle regeneration following short-term treatment. In preclinical studies, it has been demonstrated that VMB-100 induced the expression of IGF-1 levels in human muscle cells. In animals models of SUI, VMB-100 accelerated regeneration of the urinary sphincter muscle and restored urinary sphincter function after a single dose of treatment. Versameb plans to launch a Phase 2a open label, first-in-human dose ascending study of VMB-100 in female subjects with moderate stress urinary incontinence in the first half of 2024.

About Stress Urinary Incontinence
Stress urinary incontinence is a common condition amongst women in which a leakage of urine occurs during moments of physical activity due to a weakened urinary sphincter muscle. SUI is the most common type of urinary incontinence, affecting 86% of incontinent women. Despite the prevalence of SUI, there are currently no approved pharmacological therapies available in the United States. Current standard of care protocol includes short-term solutions like pelvic floor therapy or a highly invasive surgical procedure in which a sling is permanently implanted into the urethra or bladder neck.