MUVON reports 12-month Phase 2 data for MPCCOL showing sustained reductions in urinary incontinence episodes and leakage in stress urinary incontinence.
Written By: Anamika Koshti, PharmD
Reviewed By: Pharmacally Editorial Team
MUVON Therapeutics AG has reported 12-month interim follow-up data from its Phase 2 SUISSE-MPC2 trial (NCT05534269), evaluating MPCCOL, an investigational autologous muscle precursor cell therapy for female stress urinary incontinence (SUI). The findings were presented at the International Continence Society (ICS) Annual Meeting in Maastricht on 7 October 2026.
Among 30 women enrolled in the Phase 2 study, 13 had completed the 12-month assessment at the time of the interim analysis. Twelve of these patients had been classified as responders at six months. In this subgroup, reductions in stress incontinence episode frequency (IEF) and urinary leakage were maintained at one year.
An Autologous Muscle Precursor Cell Approach
SUI involves involuntary urine leakage during physical activities such as coughing, exercising or exertion. MPCCOL is designed to address impaired external urethral sphincter function using a patient’s own muscle precursor cells.
A small calf-muscle biopsy is collected under local anaesthesia, after which muscle precursor cells are isolated, expanded and prepared as the investigational product. The cells are then injected through the urethra into the external urethral sphincter using an ultrasound-guided delivery system.
The proposed approach is intended to support functional repair of the sphincter. However, the clinical outcomes reported to date primarily measure urinary symptoms and leakage rather than directly demonstrating newly regenerated muscle.
Phase 2 Six-Month Results
The 12-month findings build on six-month results announced in December 2025. SUISSE-MPC2 was a single-centre, blinded Phase 2 study involving 30 women with SUI who had failed previous conservative treatment. Participants were randomized between two MPCCOL dose levels; the study did not include a placebo or untreated control group.
At six months, stress IEF decreased by approximately 60% from baseline, while 24-hour pad weight decreased by approximately 66%. The higher-dose group showed reductions of approximately 71% and 76%, respectively.
The overall responder rate was 87%, with response defined as at least a 50% reduction in either IEF or pad weight. The study also assessed urinary incontinence and quality-of-life measures.
Twelve-Month Interim Findings
At the interim analysis, 13 participants had completed the 12-month assessment, including 12 who had been classified as responders at six months.
Among these 12 responders, stress IEF was reduced by approximately 79% from baseline at 12 months, while 24-hour urinary leakage measured by pad weight was reduced by approximately 85%. MUVON reported no deterioration across the assessed measures.
The 12-month figures should be interpreted cautiously because they apply to a small subgroup that had already demonstrated a response at six months, rather than the full 30-patient study population. They are therefore not directly comparable with the 60% and 66% reductions reported for the broader population at six months.
Safety and Long-Term Follow-Up
MUVON reported that the favorable safety profile observed during the earlier study was sustained during follow-up, with no serious treatment-related or device-related adverse events reported. Earlier assessments also found no tissue necrosis or aberrant tissue formation.
Long-term follow-up is planned through 60 months after treatment, with assessments at 12, 24, 36, 48 and 60 months. Additional participants are expected to contribute to subsequent analyses as they reach these follow-up milestones.
Interpreting the Findings
The maintenance of benefit among the 12 six-month responders provides preliminary evidence that improvements following MPCCOL treatment may persist beyond six months. However, the findings do not yet establish durable efficacy across the entire treated population.
The absence of a placebo or untreated control arm also limits interpretation, as treatment effects cannot be fully separated from placebo effects, natural symptom variation or other factors. Similarly, while the findings support the investigators’ hypothesis of functional sphincter repair, the reported clinical endpoints do not directly demonstrate muscle regeneration.
Path Toward Further Development
MUVON Chief Executive Officer Dr Deana Mohr described the 12-month findings as a de-risking step toward a potential pivotal trial. The company also said it is seeking investors and commercial partners to support further development. No pivotal-trial design, timeline or regulatory feedback was announced.
Larger controlled studies will be needed to determine whether the observed benefit is reproducible across a broader population and remains clinically meaningful over longer follow-up. The ongoing 24-month and subsequent assessments should provide further evidence on the durability and safety of MPCCOL.
References
MUVON Therapeutics Reports Positive 12-Month Phase 2 Follow-up Data Confirming Durable Efficacy of its First-in-Class Muscle Regeneration Therapy in Stress Urinary Incontinence, MUVON Therapeutics, 07 October 2026
Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon’s Muscle Precursor Cell Therapy (SUISSE MPC2), ClinicalTrials.gov ID NCT05534269
T Schmidli et al, Transurethral Injection of Autologous Muscle Precursor Cells in Resorbable Collagen Solution for the Treatment of Female Stress Urinary Incontinence (SUI) – longitudinal 12 months interim results, Continence, Volume 19, Supplement,2026,102490, https://doi.org/10.1016/j.cont.2026.102490
About the Writer
Anamika Koshti (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, and evidence-based medicine. She has authored peer-reviewed publications on Alzheimer’s disease and PCOS, presented research at national conferences, and gained hands-on experience in medical content development and clinical data interpretation. She is committed to translating complex medical research into accurate, accessible content for healthcare professionals and patients.