Efficacy and Safety of AQX-1125 in IC/BPS

A Phase 2 Study to Evaluate the Efficacy and Safety of AQX-1125 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Mediated by the Src Homology-2-domain-containing Inositol 5' Phosphatase [SHIP1] Pathway

The primary objective of this study is to evaluate the effect of 6 weeks of treatment with once daily administration of AQX-1125 compared to placebo on average daily pain in subjects with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary

Inclusion Criteria:

• Be females, ≥18 and ≤75 years of age, who have consistently had symptoms of bladder pain in addition to urinary urgency and/or urinary frequency for more than 12 months
• Have had the diagnosis of interstitial cystitis for > 6 months (pain for at least 12 months) but ≤15 years
• Have average daily pain score of at least 5 out of 10 on the 11-point Numerical Rating Scale [NRS] pain scale in the 9 days prior to baseline
• Have undergone a cystoscopy and have documented visible signs of bladder bleeding, lesions or glomerulation within the last 36 months prior to baseline.
• Subjects if of child bearing potential, must agree to avoid pregnancy and use medically acceptable method of contraception from screening visit and throughout the study.
• Must be capable of voiding independently

Exclusion Criteria:

• Pelvic floor pain (>5 out of 10 on the 11-point NRS pain scale following a pelvic pain assessment)
• Have a body mass index [BMI] of <18 kg/m2 or >39 kg/m2
• Have had a urinary tract infection including bacterial cystitis within the past 30 days.
• Have greater than 1+ hematuria on dipstick test at screening from an unknown cause
• History of previous procedure(s) (augmentation cystoplasty, cystectomy, or cystolysis) that has affected bladder function