Versameb AG, a leading pre-clinical stage biotechnology company, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application of VMB-100. This mRNA therapy, encoding human insulin-like growth factor-1 (IGF-1), aims to address the unmet medical need of stress urinary incontinence (SUI).
Scheduled for a Phase 2a open label, first-in-human dose ascending study in early 2024, VMB-100’s safety, tolerability, and efficacy will be assessed in female subjects suffering from SUI. Stress urinary incontinence is a prevalent condition affecting 86% of incontinent women, characterized by involuntary urine leakage due to a weakened urinary sphincter muscle.
Klaas Zuideveld, CEO of Versameb AG, expressed the significance of FDA clearance, marking a milestone for VMB-100’s development. He highlighted the company’s commitment to leveraging the proprietary VERSagile platform, designed to enhance mRNA therapeutics’ potency, potentially revolutionizing SUI treatment.
Professor Roger Dmochowski, Chief Medical Officer of Versameb AG, emphasized the critical role of IGF-1 in muscle regeneration, suggesting VMB-100 as a first-in-class mRNA therapy capable of restoring muscle function and effectively treating incontinence.
VMB-100, administered intramuscularly, has shown promise in preclinical studies, inducing IGF-1 expression in human muscle cells. Animal models with SUI demonstrated accelerated regeneration of the urinary sphincter muscle and restored function after a single dose. The upcoming Phase 2a study aims to further validate these findings in a clinical setting.
Stress urinary incontinence currently lacks approved pharmacological therapies in the United States, with existing treatments being short-term or invasive. Versameb’s VMB-100 presents a potential breakthrough in addressing this gap by offering sustained muscle regeneration following short-term treatment.
Versameb AG, operational since 2018, focuses on RNA-based drugs to modulate protein expression. Their VERSagile platform allows simultaneous influence on multiple therapeutic targets with one molecular construct. The company’s pipeline includes lead candidate programs in SUI, solid tumors, and rare diseases.
Read more in Versameb’s official press release.