ValamAi Announces Clearance of IND Application for VMB-100 in the Treatment of Stress Urinary Incontinence

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 a rat model of stress urinary incontinence, a single injection of VMB-100 demonstrated substantial regeneration of the urinary sphincter muscle. 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.