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

Zurich, Switzerland, October 7, 2026 – MUVON Therapeutics AG, a clinical-stage biotechnology company, reports positive 12-month interim results from the Long-Term Follow-Up Study of the Phase 2 clinical trial SUISSE-MPC2 (NCT05534269), demonstrating durable, sustained and clinically relevant bladder health benefits in patients treated with its novel proprietary muscle precursor cell (MPC)-based tissue-engineered therapy for female stress urinary incontinence (SUI). SUI represents a high unmet medical need, affecting more than 150 million women worldwide, for which no approved therapy presently addresses the underlying cause. The study results were presented in an oral session at the Annual Meeting of the International Continence Society (ICS) in Maastricht, the Netherlands, on October 7, 2026 [1].

The Long-Term Follow-Up Study was designed to evaluate whether the favorable safety profile and the marked and clinically relevant improvements in stress urinary incontinence (SUI) symptoms observed at 6 months post MPCCOL-implantation in the Phase 2 SUISSE-MPC2 study are sustained over time, confirming durable and transformative bladder health benefits. MPCCOL is MUVON's investigational tissue-engineered therapy in which a small calf-muscle biopsy is obtained under local anesthesia, from which the patient's own (autologous) muscle precursor cells (MPCs) are isolated, expanded, and prepared as the final tissue-engineered product. This is then injected via the urethra into the external urethral sphincter muscle using a proprietary, ultrasound-guided injection device, with the objective of regenerating the muscle and restoring continence function.

The SUISSE-MPC2 study met both its endpoints, showing clinically meaningful and statistically significant (p<0.0001) reductions in stress incontinence episode frequency (IEF) and in urine leakage (assessed by 24-hour pad weight) at 6 months post implantation compared to baseline [2]. The reported interim results of the Long-Term Follow-Up Study include patients from the SUISSE-MPC2 study who completed the 12-month assessment (13 to date). The favorable safety profile observed at 6 months (with no serious, therapy-related or device-related adverse events and tissue integrity confirmed in all patients) was sustained at 12 months. For all patients who were classified as responders at 6 months (12 of the 13 patients included in the Follow-Up to date), the clinically meaningful reductions in stress IEF (-79%) and urinary leakage (-85%) were fully maintained at 12 months, with no deterioration over time and across any measure. This demonstrates that MPCCOL does not merely produce a transient effect but restores sphincter muscle function in a durable, sustained and clinically meaningful manner. As the Long-Term Follow-Up Study continues additional patients will reach the 12-month and also 24-month timepoint, adding to the evidence of the therapy’s safety and efficacy. 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.

“The magnitude of improvement that is observed at 6 months with MUVON's MPC-based therapy and the fact that it is fully maintained at 12 months with no deterioration is what makes these results so compelling. Unlike existing options, MPCCOL does not just mask symptoms but addresses the underlying cause of SUI by regenerating the sphincter muscle using the patient's own cells, and these data suggest it has the potential to fundamentally transform how we approach the treatment of stress urinary incontinence in the future,” said Prof. Philip E.V. Van Kerrebroeck, MD, PhD, Vice-chair European Association of Urology (EAU) Policy Office, and member of MUVON Therapeutics' Scientific Advisory Board.

“The results our novel therapy achieved are a milestone we are truly proud of. They give us every reason to move forward with urgency and confidence. The therapy works, the durability is there, and the patient need is enormous. This one-year sustained efficacy milestone is a major de-risking step for our technology platform as it shows the significant effect holds over time, not just at a single timepoint, and it further clears the path toward a pivotal trial. We are now actively seeking investors and commercial partners who want to be part of bringing a genuinely transformative therapy to millions of women worldwide,” said Deana Mohr, PhD, Chief Executive Officer, MUVON Therapeutics.

Reference

[1]   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. Schmidli et al, 2026. https://www.doi.org/10.1016/j.cont.2026.102490

[2]   MUVON Reports Positive Phase 2 Results for its First-in-Class Muscle Precursor Cell-based Tissue-Engineered Therapy Showing Significant & Clinically Meaningful Benefits in Stress Urinary Incontinence. MUVON Therapeutics, Press release, December 3, 2025.

For more information, please contact:

Deana Mohr, PhD, CEO        
info@muvon-therapeutics.ch

About Stress Urinary Incontinence

Stress urinary incontinence (SUI) is defined as the involuntary loss of urine on effort, physical exertion or increased abdominal pressure. It is a highly prevalent disorder affecting over 150 million women worldwide, with up to 40% of women over the age of 40 and one in four women after childbirth experiencing it. SUI severely impacts physical and psychological health, undermines the quality of life of those affected and imposes a high financial burden on employers, healthcare systems and society. Many patients with SUI do not achieve satisfactory relief with conservative measures such as Kegel exercises, which often show low and short-term efficacy. More potent surgical approaches, including bulking agent injections, surgical mesh, slings, and other devices, may exhibit drawbacks, from limited durability to risks associated with invasiveness or adverse events linked to the implantation of synthetic material into the body.

About MUVON Therapeutics AG

MUVON Therapeutics is dedicated to the discovery and development of personalized regenerative treatments with the goal of establishing them as an affordable standard of care, with an initial focus on the treatment of stress urinary incontinence in women. Our mission is to help the millions of patients suffering from serious debilitating diseases regain control of their lives by offering them minimally invasive treatment for regeneration of skeletal muscle tissue. MUVON was founded in 2020 as a clinical-stage life science spin-off from the University of Zurich. For more information about MUVON Therapeutics, please visit: www.muvon-therapeutics.ch

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