Urovant Sciences has completed patient enrolment in the Phase III EMPOWUR clinical trial to examine the safety and efficacy of vibegron as a treatment for adults with symptoms of overactive bladder (OAB).
The double-blind, placebo and active comparator-controlled study has registered a total of 1,530 patients at 216 trial sites.
Patients have various symptoms of an overactive bladder such as frequent urination, sudden urge to urinate and incontinence or leakage.
They have been randomised into one of three groups for a 12-week treatment period, with a four week safety follow-up period.
Urovant Sciences chief medical officer Dr Cornelia Haag-Molkenteller said: “Exceeding our enrolment ahead of schedule underscores the interest in this trial and reinforces the need for this significantly underserved patient population.”
As part of the trial, patients are treated with once-daily oral doses of vibegron 75mg, placebo or tolterodine ER 4mg.
The first 507 patients to complete the trial were involved in a 40-week double-blind extension study to evaluate the safety of long-term treatment.
One of the co-primary goals of the trial is a change from baseline in the average number of micturitions per 24 hours in all patients.
Top-line efficacy and safety data from the EMPOWUR trial are expected to be available by the end of March next year.
Urovant’s vibegron is an oral beta-3 adrenergic agonist developed to treat OAB symptoms, including urge urinary incontinence, urgency, and urinary frequency.