Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Inclusion Criteria:

- Provide written informed consent and the willingness and ability to comply with all
aspects of the study requirements

- Males, ≥18 and ≤80 years of age at Screening Visit 1

- Have pain or discomfort in the pelvic region for at least 3 months in the last 6
months, in the absence of a urinary tract infection or other pelvic/urological cause,
and have a physician diagnosis of CP/CPPS (NIH Prostatitis Category III)

- Subjects must agree to use a condom for sexual intercourse from Screening Visit 1
until at least 90 days after the last dose of study drug, unless they have been
surgically sterilized (vasectomy) for a minimum of 6 months

- Must be capable of voiding independently for 30 days prior to screening

Exclusion Criteria:

- Diagnosis of NIH Prostatitis Categories I (acute prostatitis) or II (chronic
bacterial) prostatitis

- Diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS) with symptoms of
pain, pressure, or discomfort perceived to be related to the bladder, and associated
lower urinary symptoms for >6 weeks in the absence of infection or other identifiable
causes

- Relief of pelvic pain after voiding

- Post-void residual volume >150 mL

- Have had an unresolved (positive bacterial urine culture) urinary tract infection
within 8 weeks (inclusive) prior to Screening Visit 1

- History of previous prostate or bladder intervention within 1 month of Screening Visit
1, history of microwave therapy, transurethral resection of the prostate,
transurethral radiofrequency thermotherapy, transurethral incision of the prostate,
transurethral needle ablation, transurethral laser vaporization of the prostate,
Urolift®, Rezum, and other urological interventions within 6 months of Screening Visit
1

- Unilateral testicular or scrotal pain as the sole symptom of CP/CPPS

- Ongoing, symptomatic urethral stricture disease

- Neurologic disease or disorder affecting the bladder, ability to void spontaneously,
or directly contributing to urinary symptoms (e.g., multiple sclerosis, autonomic
neuropathy)

- Severe, excruciating pain during rectal exam (i.e. an "inability to perform the exam")

- History of chronic substance abuse, dependency or abuse of opiates, or other narcotics
within the last 2 years

- Any prior history of pelvic cancer (e.g., colorectal, genitourinary) or treatment
(radiation or chemotherapy) thereof

- Major surgery within 3 months prior to Screening Visit 1

- Have any other condition/disease which, in the opinion of the Investigator, could
compromise subject safety or interfere with the subject's participation in the study
or in the evaluation of the study results.