ValamAi Limited today announced that regulators have cleared its Investigational New Drug (IND) application for VMB-100, a next-generation mRNA-encoded therapeutic candidate, clearing the way for a planned Phase IIa clinical study.
VMB-100 is ValamAi's engineered IGF-I mRNA candidate, delivered by intra-urethral injection into the sphincter muscle. In preclinical models, VMB-100 demonstrated substantial regeneration of the urinary sphincter muscle and dose-dependent improvement in leak point pressure. With IND clearance secured, ValamAi is preparing to initiate a Phase IIa safety and Phase IIb efficacy & dose-finding study in women with stress urinary incontinence.
Stress urinary incontinence affects an estimated 1 in 3 women, with no FDA-approved therapeutics currently available. ValamAi believes VMB-100 has the potential to be a first-in-class regenerative treatment option for this underserved patient population.
ValamAi Limited is a clinical-stage company based in Abu Dhabi, United Arab Emirates, focused on transforming RNA therapeutics to treat unmet medical needs. Its lead program, VMB-100, is an engineered IGF-I mRNA therapeutic in development for stress urinary incontinence and disc herniation, alongside a growing pipeline spanning dermatology and oncology.
Media Contact: info@valamai.com
