Interim Follow-Up Data Show Durable Reductions in Urinary Leakage and Incontinence Episodes, With a Favorable Safety Profile
MUVON Therapeutics AG, a clinical-stage biotechnology company, has reported positive 12-month interim results from the long-term follow-up study of its Phase 2 SUISSE-MPC2 trial (NCT05534269). The findings indicate that patients treated with the company's investigational muscle precursor cell (MPC)-based therapy, MPCCOL, maintained clinically meaningful improvements in bladder health for stress urinary incontinence (SUI).
The results were presented during an oral session at the Annual Meeting of the International Continence Society (ICS) in Maastricht, the Netherlands, on October 7, 2026.
Key Highlights
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Sustained efficacy: Patients who responded to treatment at six months maintained their improvements at 12 months.
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Reduced incontinence episodes: Stress incontinence episode frequency remained reduced by 79% from baseline.
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Reduced urinary leakage: Urinary leakage, measured by 24-hour pad weight, remained reduced by 85% from baseline.
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Favorable safety profile: No serious therapy-related or device-related adverse events were reported, and tissue integrity was confirmed in all patients.
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Continued follow-up: The study will collect additional data at 12 and 24 months to further assess the therapy's long-term safety and efficacy.
About the SUISSE-MPC2 Long-Term Follow-Up Study
The follow-up study is evaluating whether the favorable safety profile and clinically meaningful improvements observed six months after MPCCOL implantation are maintained over time.
The interim analysis includes 13 patients who had completed the 12-month assessment. Of these, 12 were classified as responders at six months.
Among these 12 responders, the reductions in stress incontinence episode frequency and urinary leakage were fully maintained at 12 months, with no reported deterioration across the measured outcomes.
The original Phase 2 SUISSE-MPC2 study met both its endpoints, demonstrating statistically significant reductions in stress incontinence episode frequency and urinary leakage at six months compared with baseline (p<0.0001).
The long-term follow-up study is ongoing, and additional patients are expected to reach the 12-month and 24-month assessment points.
MPCCOL: A Regenerative Approach to Stress Urinary Incontinence
MPCCOL is MUVON Therapeutics' investigational, tissue-engineered therapy designed to address the underlying cause of SUI by regenerating the external urethral sphincter muscle.
The treatment process involves:
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Muscle biopsy: A small sample of the patient's calf muscle is collected under local anesthesia.
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Cell isolation and expansion: The patient's own muscle precursor cells are isolated, expanded, and prepared into a tissue-engineered product.
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Targeted injection: The cells are injected through the urethra into the external urethral sphincter muscle using a proprietary ultrasound-guided injection device.
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Muscle regeneration: The therapy is intended to regenerate sphincter muscle tissue and help restore continence function.
By using the patient's own cells, MPCCOL is being developed as a personalized regenerative approach rather than a treatment that only manages symptoms.
Favorable Safety Profile Maintained at 12 Months
The favorable safety profile observed at the six-month assessment was maintained at 12 months. No serious therapy-related or device-related adverse events were reported, and tissue integrity was confirmed in all patients.
These interim findings provide additional evidence for the continued evaluation of MPCCOL's longer-term safety and potential durability. Further follow-up will be needed to establish the therapy's safety and efficacy in a larger patient population.
Expert Perspective on the Findings
Prof. Philip E.V. Van Kerrebroeck, MD, PhD, Vice-chair of the European Association of Urology (EAU) Policy Office and a member of MUVON Therapeutics' Scientific Advisory Board, highlighted the sustained improvements observed at 12 months.
He noted that maintaining the magnitude of improvement seen at six months could distinguish MPCCOL from approaches that primarily manage SUI symptoms. He added that the findings suggest the therapy may have the potential to change future treatment approaches by targeting the underlying sphincter muscle dysfunction.
MUVON Therapeutics' Next Steps
Deana Mohr, PhD, Chief Executive Officer of MUVON Therapeutics, described the sustained one-year results as an important milestone for the company's technology platform.
She emphasized that the maintenance of treatment effects over time represents a significant step toward reducing development risk and advancing the program toward a pivotal clinical trial.
MUVON Therapeutics is actively seeking investors and commercial partners to support the continued development of its regenerative therapy.
The Unmet Need in Stress Urinary Incontinence
Stress urinary incontinence is the involuntary leakage of urine during activities that increase abdominal pressure, such as coughing, sneezing, or physical exertion.
The condition affects more than 150 million women worldwide and can significantly affect physical health, psychological well-being, and quality of life. It also creates a substantial financial burden for patients, employers, and healthcare systems.
Current management options include pelvic floor muscle exercises, bulking-agent injections, surgical slings, mesh, and other procedures or devices. However, these approaches may not provide satisfactory or durable relief for all patients and can involve limitations or procedure-related risks.
Because SUI often involves dysfunction of the urethral sphincter, regenerative approaches such as MPCCOL are being investigated for their potential to address the underlying tissue damage rather than only alleviate symptoms.
Study Funding and Support
Both the Phase 2 SUISSE-MPC2 study and the Long-Term Follow-Up Study were funded and supported by the University of Zurich and the Wyss Zurich Translational Center.
About MUVON Therapeutics AG
MUVON Therapeutics AG is a clinical-stage biotechnology company focused on developing personalized regenerative treatments, with the goal of establishing affordable standards of care.
The company's initial focus is stress urinary incontinence in women, with its investigational MPC-based therapy, MPCCOL, designed to regenerate sphincter muscle tissue and potentially restore continence function.
Regulatory note: MPCCOL remains investigational. The reported findings are interim results from a limited number of patients and do not establish definitive long-term safety or efficacy.
