URO-902 / Sumitomo Pharma - LARVOL DELTA

Gene Therapy With URO-902 (pVAX/hSlo) for the Treatment of Female Patients With Overactive Bladder and Urge Urinary Incontinence: Safety and Efficacy From a Randomized Phase 2a Trial. (PubMed, J Urol) - "Among patients receiving URO-902 24 mg, 48 mg, and placebo, 46%, 54%, and 54%, respectively, experienced ≥1 treatment-emergent AEs, most commonly urinary tract infection (0%, 15%, 4%) and hematuria (6%, 8%, 8%). In this phase 2a trial, treatment with URO-902 was associated with improvements vs placebo in efficacy and patient-reported outcomes and was safe and well tolerated."

Gene therapy • Journal • P2a data • Anesthesia • Gene Therapies • Infectious Disease • Nephrology • Overactive Bladder • Urinary Incontinence • Urology

Long-term Efficacy and Safety of URO-902 (pVAX/hSlo) in Women With Overactive Bladder and Urge Urinary Incontinence: Final Results of a Phase 2a Trial (AUA 2023) - P2a | "In the ITT-E population, mean age was 64.7 years; 13.5% had prior onabotulinumtoxinA treatment. URO-902 24 or 48 mg showed durable, meaningful improvements from baseline in micturitions, urgency episodes (dose dependent), and UUI episodes, consistent with previously reported QoL improvements at 12 weeks, and was safe and well tolerated in this phase 2a trial. Interpretation of efficacy vs placebo was limited by use of additional OAB treatments after week 24."

Clinical • Late-breaking abstract • P2a data • Anesthesia • Gene Therapies • Infectious Disease • Nephrology • Overactive Bladder • Urinary Incontinence • Urology

Efficacy and Safety of a Novel Gene Therapy (URO-902; pVAX/hSlo) in Female Patients With Overactive Bladder and Urge Urinary Incontinence: Results From a Phase 2a Trial (WSAUA 2022) - P2a | "One patient (48-mg arm) had asymptomatic elevated PVR urine volume at week 2 (resolved spontaneously, did not require catheterization). Conclusions : In this phase 2a trial of women with OAB and UUI, a single dose of URO-902 24 or 48 mg was associated with clinically relevant improvement in efficacy and QoL endpoints and was safe and well tolerated."

Clinical • Gene therapy • P2a data • Gene Therapies • Infectious Disease • Nephrology • Overactive Bladder • Urinary Incontinence • Urology