Versameb AG (“Versameb”), a pre-clinical stage company focused on transforming RNA therapeutics to treat unmet medical needs, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application of VMB-100, a potency enhanced messenger ribonucleic acid (mRNA) encoding human insulin-like growth factor-1 (IGF-1), for the treatment of stress urinary incontinence (SUI).
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.”