Drug for treatment of bladder pain syndrome/interstitial cystitis begins Phase II trial

A drug for the treatment of bladder pain syndrome/interstitial cystitis (BPS/IC) has entered into Phase II testing. AQX-1125 has been developed by Aquinox Pharmaceuticals Inc for the treatment of BPS/IC and is the focus of the LEADERSHIP study currently being conducted in Canada.

BPS/IC is a chronic disease of the bladder, which most commonly causes the increased need to urinate and pelvic pain. It is not known exactly what causes the disease, but it is largely believed that a dysfunctional bladder may play a role in its development. The most prevalent sufferers of BPS/IC are women, with between 3.3 and 7.9 million women suffering with the disease within the US, according to a study by the RAND Corporation.

The Phase II study of AQx-1125 involves around 70 patients suffering with BPS/IC at academic and community facilities throughout Canada. The trial is being conducted in order to assess the effectiveness and safety of the drug for use as a treatment. Aquinox are expecting to complete the Phase II clinical trial at some point in the second half of 2014.

Current treatments for IBS/IC are often ineffective at addressing all of the symptoms of the illness and are often highly invasive. Many of the treatment methods require a catheter be used to instil it directly into the bladder. Current treatments do not all address the disease itself, they instead largely focus upon reduce the symptoms experienced by patients.

It is believed that BPS/IC is caused by inflammation within the bladder tissue caused by the contents of the urine; this is largely caused by a dysfunction in the lining of the bladder. The inflammation then causes pain and irritation, which can often be incredibly debilitating.

Preclinical studies have found that oral administration of AQX-1125 in high doses can reach the bladder through unmetabolised urine and through the blood. The studies also found that the drug can help to reduce pain and inflammation.