Urovant Sciences announced that positive interim results from a Phase 2a trial of its investigational novel gene therapy, URO-902, were presented Friday at the 2022 annual meeting of the American Urological Association (AUA2022). The meeting is being held in New Orleans, from May 13-16, 2022. Presented as a late-breaker during the plenary session, the interim results support that in women with OAB, not well managed by oral therapies, a single dose of URO-902 was safe and well tolerated.

This was a prespecified, 12-week interim analysis of a 48-week multicenter, randomized, double-blind, placebo-controlled, dose-escalation study (NCT04211831 [3]). URO-902 was administered via direct intradetrusor injections via cystoscopy under local anesthesia. Of the 80 female patients who were randomized, 68 completed week 12 of the study and 74 were included in the intent-to-treat population.

The mean age was 64.7 years. At week 12, both URO-902 24 mg and 48 mg were associated with clinically relevant improvement compared with placebo in mean daily micturition (urination), urgency episodes, UUI episodes, OAB questionnaire symptom bother score, and proportion of patient global impression of change responders. Treatment-emergent adverse events occurred in 45.5% of patients receiving URO-902 24 mg, 46.2% receiving 48 mg, and 50.0% receiving placebo.

The most commonly occurring adverse event was urinary tract infection (0% in individuals receiving the 24 mg dose of URO-902; 15.4% in those receiving the 48 mg dose; and 3.8% in those receiving placebo). One patient in the 48 mg arm of the study had asymptomatic elevated post-void residual urine volume at week 2; this resolved spontaneously and did not require catheterization.