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Urovant Gene Therapy Yields Improvements in Overactive Bladder

Further results will be presented at the American Urological Association Annual Meeting, May 13-16, 2022.

Urovant Sciences’ human cDNA encoding maxi-K channel gene therapy URO-902 was well-tolerated and yielded improvements in participants with overactive bladder (OAB) not well managed by oral therapies, according to topline results from a phase 2a trial (NCT04211831).

“URO-902 showed a clinically meaningful and statistically significant effect on a number of relevant outcome measures in OAB including number of micturitions, urgency episodes, and quality of life indicators compared to placebo, 12 weeks post-administration,” Cornelia Haag-Molkenteller, MD, PhD, executive vice president and chief medical officer, Urovant Sciences, said in a statement. “URO-902 was well tolerated, compared to placebo. The most common adverse event (AE) was urinary tract infection, in both treatment groups. We are encouraged by these positive results and pending the completion of the study in Fall 2022 and we look forward to discussing next steps for the URO-902 clinical development plan.”

The phase 2a, randomized, double-blind, placebo-controlled exploratory study enrolled 80 female patients who received either 24 mg, 48 mg, or placebo via direct intradetrusor injections into the bladder wall under local anesthesia.The primary endpointwas assessed at 12 weeks post-administration and patients were followed for up to 48 weeks.

The primary endpoint assessed average daily number of Urge Urinary Incontinence (UUI) episodes and the secondary endpoint assessed safety via AEs. Other endpoints included number of micturition and quality of life indicators.

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The therapy was well-tolerated and treated participants experienced clinically meaningful and statistically significant reductions in micturitions and urgency episodes as well as improvements in quality-of-life indicators compared with placebo 12 weeks post-treatment.


“These promising results suggest that URO-902 could potentially offer a new treatment option for patients with overactive bladder who have been inadequately managed by oral pharmacologic therapy,” principal investigator Kenneth Peters, MD, chief, department of urology, Beaumont Hospital, Royal Oak, and medical director, Beaumont Women’s Urology and Pelvic Health Center, and professor and chair of urology, Oakland University William Beaumont School of Medicine, Rochester, Michigan, added to the statement.

These topline results will be presented in more detail at the American Urological Association annual meeting, May 13-16, 2022, in New Orleans, Louisiana.

REFERENCE
Urovant Sciences Announces Positive Topline Results of Phase 2a Trial of its Potential Novel Gene Therapy, URO-902. News release. Urovant Sciences. March 7, 2022. https://www.businesswire.com/news/home/20220307005756/en/Urovant-Sciences-Announces-Positive-Topline-Results-of-Phase-2a-Trial-of-its-Potential-Novel-Gene-Therapy-URO-902