FDA clearance spurs Versameb's clinical trial for mRNA drug against incontinence

Stress urinary incontinence (SUI) significantly impacts the quality of life for millions of women globally (affecting 86% of incontinent women), causing urine leakage during physical activity due to a weakened urinary sphincter muscle. Despite its major prevalence, there are currently no approved pharmacological therapies available.

Versameb, a Basel-based startup focused on developing RNA-based drugs for various diseases, including Stress Urinary Incontinence (SUI), developed VMB-100 using its proprietary VERSagile platform, which optimizes the application of functional RNA in a therapeutical context. With lead candidate programs in stress urinary incontinence (SUI), solid tumors and rare diseases, Versameb is driving innovative research around RNA therapeutics. The company’s drug candidate VMB-100, based on the VERSagile platform is  a sequence-engineered mRNA encoding for human insulin-like growth factor-1 (IGF-1). If successful, the drug has the potential to be the first pharmacological therapy against SUI.

Preclinical studies have shown that VMB-100, which is administered intramuscularly, induces IGF-1 expression in human muscle cells, accelerating the regeneration of the urinary sphincter muscle, thus restoring, and maintaining SUI patients’ continence after a single dose. The U.S. Food and Drug Administration (FDA) gave a green light to Versameb’s VMB-100 drug for its Investigational New Drug (IND) application.

Pharmaceutical companies submit an IND application to the FDA to initiate clinical trials of a new drug in humans. This approval allows Versameb to proceed with its Phase 2a open-label study, scheduled for the first half of 2024. The study will evaluate the safety, tolerability, and efficacy of VMB-100 in female patients suffering from SUI. With the upcoming Phase 2a study, VMB-100 can soon be accessible for patients, offering sustained muscle regeneration after only short-term treatment.

(SR / press release)