Urovant Sciences (NASDAQ:UROV) announced today the publication of the safety and efficacy results of URO-902 in female patients with overactive bladder (OAB) from two double-blind, placebo-controlled randomized Phase 1 trials. The first trial was conducted with instillation therapy and the second trial with direct injections into the bladder wall under local anesthesia. The peer-reviewed publication was published online in Neurology and Urodynamics. URO-902, a naked DNA plasmid-based gene therapy administered via injection directly into the bladder, is currently being evaluated as a potential treatment for OAB in an ongoing Phase 2a study in the United States. In the trials, URO-902 was well tolerated and the administration via direct injection procedure demonstrated statistically significant improvement in OAB symptoms.
“This is the first publication of clinical data for a potential novel gene therapy delivered directly to the bladder,” said Dr. Eric Rovner, Professor of Urology at the Medical University of South Carolina and the lead author on the publication. “URO-902 has the potential to be an important new treatment for patients with overactive bladder who have failed oral pharmacologic therapy.”