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news.Aquinox Pharmaceuticals (Aquinox) has announced results from its Phase II LEADERSHIP randomized clinical trial investigating the therapeutic potential of AQX-1125 in treating pain in patients with bladder pain syndrome/interstitial cystitis (BPS/IC).
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While AQX-1125 demonstrated a reduction in pain for patients on AQX-1125 as compared to those patients on placebo following six weeks of treatment, the difference did not reach statistical significance (p = 0.061).
"While we did not meet our statistical endpoint, we are encouraged to see in our first BPS/IC trial a positive trend in reduction of pain with AQX-1125 compared to placebo. Almost half of patients treated with AQX-1125 achieved a 2-point or greater reduction in pain," said David Main, President & CEO at Aquinox.
"We believe today’s top line data support further development of AQX-1125 for BPS/IC patients."
The mean change in pain score for patients on 200mg oral, once daily AQX-1125 vs. placebo was a reduction of 2.4 vs. 1.3 points, respectively.
The primary endpoint was based on an 11-point numeric rating scale recorded by electronic diary. Approximately 49% of patients receiving AQX-1125 demonstrated a 2-point or greater reduction in pain compared to 34% of patients receiving placebo. Secondary endpoints are currently being analyzed and will be reported at a future meeting.
Consistent with past results, the LEADERSHIP trial demonstrated AQX-1125 to be well tolerated. No serious adverse events were recorded during the trial. The overall adverse event rate was similar between AQX-1125 and placebo.
The most frequently reported adverse events were gastrointestinal disorders (32% for AQX-1125 vs. 34% for placebo).