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Novel Drug AQX-1125 Shows Early Promise in Moderate to Severe IC/BPS

Nickel JC, Egerdie B. Davis E, Evans R, Mackenzie L, Shrewsbury SB. A Phase II Study of Efficacy and Safety of a Novel, Oral SHIP1 Activator, AQX-1125, in Subjects with Moderate to Severe Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). J Urol. 2016 Mar 8. pii: S0022-5347(16)03368-1. doi: 10.1016/j.juro.2016.03.003. [Epub ahead of print]

AQX-1125, a novel oral drug that appears to have anti-inflammatory properties, is being tested in several different conditions, including allergic asthma, COPD, and interstitial cystitis/bladder pain syndrome (IC/BPS). This report discusses the results of a 6-week study that evaluated the effects of AQX-1125 on bladder pain and urinary symptoms in women with IC/BPS and persistent bladder pain despite treatment with other modalities. A total of 37 women received AQX-1125 once daily for 6 weeks and 32 received placebo in this randomized, double-blind, placebo-controlled, multicenter trial. Investigators found that after 6 weeks of treatment, daily pain scores (that the women recorded in e-diaries) decreased by an average of 2.4 points on an 11-point scale, compared with just 1.4 points for women who received placebo. Likewise, women receiving AQX-1125 had significant decreases in maximum daily pain, IC symptoms, and urinary frequency. There were no serious adverse events associated with AQX-1125, and overall, there were similar rates of adverse events in the placebo and AQX-1125 groups. Based on these findings, investigators said that AQX-1125 deserves further investigation as a potential treatment for women with moderate to severe IC/BPS.