MP72-13 SHIP-1 ACTIVATION PROVIDES SIGNIFICANT BENEFIT IN INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME: RESULTS OF A PHASE 2 RANDOMIZED PLACEBO CONTROLLED TRIAL

Abstract

You have accessJournal of UrologyInfections/Inflammation/Cystic Disease of the Genitourinary Tract: Interstitial Cystitis1 Apr 2016MP72-13 SHIP-1 ACTIVATION PROVIDES SIGNIFICANT BENEFIT IN INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME: RESULTS OF A PHASE 2 RANDOMIZED PLACEBO CONTROLLED TRIAL J. Curtis Nickel, Blair Egerdie, Edward Davis, Robert Evans, Heidi Biagi, and Stephen Shrewsbury J. Curtis NickelJ. Curtis Nickel More articles by this author , Blair EgerdieBlair Egerdie More articles by this author , Edward DavisEdward Davis More articles by this author , Robert EvansRobert Evans More articles by this author , Heidi BiagiHeidi Biagi More articles by this author , and Stephen ShrewsburyStephen Shrewsbury More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1626AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES AQX-1125, a novel SH2-containing inositol-5′-phosphatase 1 (SHIP1) activator represents a novel once-daily, oral therapy for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). We conducted a 6-week randomized, double-blind, placebo-controlled Phase 2 RCT to assess the safety and efficacy of AQX-1125 in addition to existing therapy on daily bladder pain using e-diaries and in standardized BPS questionnaires. METHODS 69 women with moderate to severe IC/BPS, having had cystoscopy to exclude other disease within 3 years and a baseline mean pain score of ≥5, urinary frequency, urgency and nocturia were randomized to daily 200 mg AQX-1125 or placebo for 6 weeks. Daily average and maximal pain scores and urinary frequency were recorded by e-diary and in the clinic. The O′Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (ICSI/PI), Bladder Pain IC Symptom Score (BPIC-SS) and Short Form 12 Health Survey (SF-12v2) questionnaires were administered. Safety data was collected through 6 weeks treatment and 4 weeks follow up. RESULTS At six weeks, the mean average e-diary pain score (primary efficacy outcome) and clinic average pain as well as maximum pain (e-diary and clinic recorded) and percent change in mean average pain score had decreased more in the 37 patients treated with AQX-1125 than placebo (see Table). Significant statistical differences at 6 weeks in the AQX-1125 group compared to placebo group for change from baseline were noted for the mean ICSI, ICPI and BPIC-SS (see Table). Urinary voiding frequency and SF-12v2 scores also improved. No safety issues were noted in either group. CONCLUSIONS AQX-1125 provided greater reduction in bladder pain and symptoms at 6 weeks, compared to placebo in women with moderate to severe IC/BPS and was well tolerated. Further clinical studies with AQX-1125 for IC/BPS are planned in 2016. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e957 Advertisement Copyright & Permissions© 2016MetricsAuthor Information J. Curtis Nickel More articles by this author Blair Egerdie More articles by this author Edward Davis More articles by this author Robert Evans More articles by this author Heidi Biagi More articles by this author Stephen Shrewsbury More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...