Following this clearance, Versameb plans to launch a Phase IIa 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.”