Aquinox completes patient enrollment in Phase II LEADERSHIP trial of AQX-1125 to treat BPS/IC

A total of 70 patients have been enrolled in the trial, which is examining the ability of AQX-1125 to reduce pain in female patients with BPS/IC, a chronic inflammatory bladder disease characterized by pelvic pain and increased urinary urgency and/or frequency.

The company’s lead drug candidate AQX-1125 is a small molecule activator of SHIP1, which is a regulating component of the PI3K cellular signaling pathway.

The trial is being conducted at community and academic sites across Canada and the US.

Primary endpoint of the trial is the difference in the change from baseline in mean daily bladder pain scores based on an 11-point numerical rating scale at six weeks recorded by daily, electronic diary for patients administered AQX-1125 as compared to placebo.

Aquinox president and CEO David Main said: "BPS/IC is a largely under-reported but surprisingly common disease of the bladder characterized by chronic, severe pain and frequent urination, where patients have limited effective treatment options.

"With LEADERSHIP, we have focused on the inflammation underlying BPS/IC to explore how oral, once daily AQX-1125, with its broad anti-inflammatory and favorable drug-like properties, may reduce pain and ultimately improve quality of life.

"With 68 patients randomized to date and a higher completion rate than forecast for the trial, we have met our enrollment objectives.

Main said that the company anticipates the last patient final visit in April 2015 and reporting of top line data near mid-year.

In multiple preclinical studies and clinical trials, AQX-1125 has also showed preliminary safety and favorable drug properties.

Currently, the company is exploring AQX-1125 as an oral, once daily treatment in several Phase II trials.