Muvon Therapeutics announces First Patient Enrolled in Phase II Clinical Study in Female Patients with Stress Urinary Incontinence using Novel Regenerative Cell Therapy
Zurich, Switzerland, October 27, 2022 – Muvon Therapeutics AG, an innovative clinical-stage biotechnology company, today announced that the first patient with Stress Urinary Incontinence has been enrolled as part of the planned Phase II clinical trial (SUISSE MPC 2-Study) using its novel proprietary cell therapy platform.
This is a randomized blinded clinical study, evaluating the safety and efficacy of a low and high dose of autologous skeletal muscle precursor cell injections into the urethral sphincter muscle of women living with stress urinary incontinence (SUI) with the goal of restoring strength and function. An earlier Phase I study presented at the International Continence Society (ICS) Annual Meeting 2022 in Vienna, Austria, demonstrated the safety, feasibility and potential efficacy. No serious adverse events or unexpected adverse events were observed.
This Phase II study is funded through the University of Zurich with further support from the Wyss Zurich translational center.
Deana Mohr, PhD, CEO and co-founder stated: "The goal of the study is to evaluate the efficacy of a novel treatment for SUI in women, with a unique mechanism of action, using their own muscle precursor cells to regenerate the urinary sphincter muscle. This minimally invasive therapy offers significant differentiation with ease of administration and patient tolerability relative to the standard of care including bulking agents, slings and meshes with related surgical complications."
Jenny Prange, PhD, CSO and co-founder of Muvon Therapeutics, added: "We have made tremendous progress with our qualified and validated manufacturing process to facilitate the production of patient-specific muscle precursor cells to enable this study."
Dr John Coelho, Medical Affairs Leader, concluded: "We remain on schedule with our comprehensive clinical development program milestones to advance this novel therapy which has drawn considerable interest from the international research, medical and most importantly, the patient community."
A sufficient number of patients will be enrolled to complete the study with 70 evaluable patients. Patients will participate in the study for up to approximately 9 months, and include a baseline visit for screening, a visit for a muscle biopsy, an injection of muscle precursor cells, and follow-up visits after 1, 3 and 6-months post-injection. All patients will be treated with one of the two doses assigned according to the study's randomization plan. A core study team and an independent Data Safety Monitoring Board have been established drawn from leading international centers of excellence to oversee the safety aspects of this trial.
To provide potential study participants with the opportunity to learn more about this Phase II clinical trial, Muvon Therapeutics is collaborating with admedicum, a company specializing in patient engagement. Together with a qualified patient expert, admedicum has created a study website where patients can find adequate information about the study, pre-check their eligibility for study participation, and personal support via a patient information service: www.muvon-trials.ch
More information about the trial: https://clinicaltrials.gov/ct2/show/NCT05534269
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, which affects over 200 million people worldwide. It has severe impact on both physical and psychological health and imposes a high burden on the quality of life of affected individuals.
More than 40 percent of women above the age of 40 are affected and every fourth woman is affected after childbirth.
For many patients, conservative treatments, such as Kegel exercises, do not provide satisfactory relief, while more invasive surgical options, such as bulking agent injections, surgical mesh and slings or other devices, may also exhibit drawbacks ranging from limited, short-term relief to potentially serious adverse events due to the implantation of synthetic material into the body.
For more information, please contact:
Dr Deana Mohr, CEO
About Muvon Therapeutics AG
Muvon Therapeutics, founded in 2020 as a clinical-stage company, is a spin-off from the University of Zurich, currently being accelerated by the Wyss Zurich Translational Center. 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. 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. For more information about Muvon Therapeutics, please visit: www.muvon-therapeutics.com
About admedicum GmbH & Co KG
admedicum aligns the needs of patients with the products and services of the healthcare industry with one goal, to develop patient driven solutions. Founded by caregivers and healthcare industry professionals, admedicum brings expertise in patient engagement and patient access in research, development and access to treatment, medical devices and services. For more information about admedicum, please visit: www.admedicum.com
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