Muvon Therapeutics reported promising results from a small Phase 2 trial of its muscle cell therapy for stress urinary incontinence (SUI), showing a 60% reduction in episode frequency and positioning the therapy as a potential alternative to synthetic implants.
The trial enrolled 30 women who had not responded to conservative SUI treatments. Each patient underwent a calf-muscle biopsy under local anesthesia. Muscle precursor cells (MPCs) from the biopsy were isolated, expanded, and injected into the external urethral sphincter using ultrasound guidance, with the goal of regenerating muscle function.
Participants received either a high or low dose of the therapy. After six months, the frequency of stress incontinence episodes fell by 60% overall, meeting the trial’s primary endpoint. High-dose patients saw the greatest improvement, with a 71% reduction, while the low-dose group experienced a reduction above 50%.
Secondary outcomes assessing urine loss through 24-hour pad weight showed similar improvements. Both dosing groups saw at least a 50% reduction, with the high-dose group achieving a 76% drop. Overall, 87% of patients met the trial’s response criteria, defined as a 50% or greater reduction in episode frequency or pad weight. Philip Van Kerrebroeck, M.D., Ph.D., an independent urology expert at the University of Maastricht, said a 50% reduction is considered clinically meaningful.
The therapy was well tolerated, with no serious adverse events linked to the treatment or the delivery procedure. MRI and clinical assessments confirmed tissue integrity in all patients. Muvon plans to present more detailed data at upcoming medical conferences and in a peer-reviewed journal.
Muvon CEO Deana Mohr, Ph.D., said the results “further validate our therapeutic approach, which directly addresses the functional muscle deficiency in SUI and could reduce reliance on synthetic material implants.” Surgical mesh slings, a common SUI treatment, carry a risk of post-operative complications.
The trial, sponsored by the University of Zurich, originally planned to enroll 70 patients but ultimately included 30. Updates on ClinicalTrials.gov indicate adjustments were made to ensure sufficient evaluable data from the smaller cohort.
Related topic：
