Muvon Therapeutics has linked its cell therapy to a 60% drop in stress incontinence episode frequency in a small phase 2 trial, leading the biotech to pitch the candidate as a way to reduce reliance on synthetic material implants.
The study enrolled 30 women with stress urinary incontinence (SUI) who had tried conservative therapy without success. Physicians took a calf-muscle biopsy from each patient under local anesthesia. Muscle precursor cells (MPCs) taken in the biopsy were isolated, expanded and injected into the external urethral sphincter muscle in an ultrasound-guided procedure. The goal was to regenerate the muscle.
Participants received one of two doses of the MPC-based tissue-engineered therapy. After six months, stress incontinence episode frequency had fallen by 60% from baseline, achieving the primary endpoint of the trial. The reduction was greatest, 71%, on the high dose but was still above 50% on the low dose.
Muvon also saw a dose response on a secondary endpoint that assessed urine loss by recording 24-hour pad weight. Again, the biotech reported at least a 50% reduction in both cohorts, with the high-dose arm leading the way with a 76% drop in pad weight.
Muvon said 87% of patients met the treatment response criteria. Participants needed to have had a 50% reduction in either stress incontinence episode frequency or pad weight to meet the response criteria. The University of Maastricht’s Philip Van Kerrebroeck, M.D., Ph.D., who Muvon called a study-independent urology expert, said in a statement that a 50% reduction is recognized as clinically relevant.
No serious adverse events related to the tissue-engineered therapy or to the ultrasound-guided delivery device were reported. MRI and clinical assessments confirmed tissue integrity in all patients. Muvon said that, overall, the therapy was safe and well tolerated. Researchers plan to share a closer look at the data at upcoming medical conferences and in a peer-reviewed journal.
Muvon CEO Deana Mohr, Ph.D., said in a statement that the readout “further validates our therapeutic approach which directly addresses the functional muscle deficiency in SUI and could reduce reliance on synthetic material implants.” Surgical mesh sling procedures are a common treatment for SUI but carry a risk of postoperative complications.
The University of Zurich, which sponsored the trial, originally intended to enroll a larger number of patients, according to the ClinicalTrials.gov entry. Before an update in April, the listing said that “to guarantee enough outcome data, a sufficient number of patients will be enrolled to complete the study with 70 patients.” The first April update said the actual enrollment number was 50—a figure that was changed to 30 a week later.
As part of the second update, the sponsor edited the line about completing the trial with 70 patients to guarantee enough outcome data. Following the edits, the line read “to generate enough outcome data, a sufficient number of patients will be enrolled to yield evaluable data from 30 patients.” A spokesperson for Muvon explained the changes via email.
"ClinicalTrials.gov does not permit for reasoning for adjustment of sample size. Of the 50 screened and enrolled, 20 were deemed not eligible after exclusion criteria assessment at the hospital (i.e. urge incontinence was diagnosed not stress urinary incontinence). Muvon’s novel therapy is specifically for stress urinary incontinence. Accordingly, the 50 evaluable was appropriately adjusted to 30 evaluable and confirmed," the spokesperson said.
Editor’s Note: This story was updated Dec. 5 to include a statement from Muvon.