Efficacy and Safety of AQX-1125 in IC/BPS

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 (but 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 NRS pain scale
in the 7 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