Aquinox Pharmaceuticals commences phase II clinical trial of AQX-1125 in bladder pain syndrome / interstitial cystitis
Aquinox Pharmaceuticals Inc., a private, venture-backed, pharmaceutical company developing novel and targeted small molecule therapeutics for the treatment of inflammatory disease, have announced that it has begun dosing patients in a Phase II clinical trial of its lead clinical candidate, AQX-1125, a potent SHIP1 activator, for the treatment of bladder pain syndrome/interstitial cystitis (BPS/IC). The trial, known as the LEADERSHIP study, is being conducted at community and academic sites across Canada evaluating the safety and efficacy of AQX-1125 in approximately 70 BPS/IC patients. The Company recently received a No Objection Letter to its Clinical Trial Application from Health Canada and anticipates completing the trial in the second half of 2014.
“Our novel anti-inflammatory drug has the opportunity to revolutionize treatment of this debilitating condition by targeting what is believed to be an underlying cause of the disease,” stated Mr. David Main, President and CEO of Aquinox. “A successful outcome of this trial will allow us to move rapidly into pivotal trials on the path to approval.”
BPS/IC is an increasingly common and chronic disease of the bladder affecting tens of millions of people worldwide, predominantly women, with no consistently effective interventions. Current therapies are often inadequate and invasive, typically requiring instillation of the treatment directly into the bladder through a catheter and may temporarily reduce symptoms rather than treat the underlying disease. BPS/IC is thought to be caused by dysfunction of the bladder lining leading to tissue inflammation from urine contents, such as potassium, causing irritation and radiating pain, which is often debilitating. After oral administration, preclinical studies have shown that high concentrations of AQX-1125 get to the bladder tissue both by circulating in the blood as well as by being excreted unmetabolized in the urine. Furthermore, AQX-1125 demonstrated compelling efficacy in a preclinical model of BPS/IC by reducing both bladder inflammation and inflammatory pain.
“Patients suffering from BPS/IC desperately need a breakthrough treatment,” said Dr. Stephen Shrewsbury, Senior Vice President, Clinical Development and Chief Medical Officer of Aquinox. “We have placed a high priority on the LEADERSHIP study, and are working with leading clinicians in the urological field to ensure its successful conclusion.”
About Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC)
Bladder pain syndrome/interstitial cystitis (BPS/IC) is a chronic bladder disease characterized by pelvic pain and increased urinary urgency and/or frequency. For many BPS/IC sufferers, these symptoms are severe and adversely affect all major aspects of their lives, including overall physical and emotional health, employment, social and intimate relationships, and leisure activities. While the cause of the disease remains largely unknown, dysfunction of the bladder lining is thought to be a significant contributor. Historically considered an uncommon disease, BPS/IC is now recognized as an increasingly prevalent medical condition that predominantly affects women. The RAND Corporation recently conducted the largest epidemiological study ever and found that between 3.3 and 7.9 million women in the US alone suffer from BPS/IC symptoms. Unfortunately existing treatments provide little or no benefit and many BPS/IC patients remain dissatisfied with available therapies. As most current therapies and those in development are analgesics focused solely on symptomatic relief, new and innovative treatments that target the underlying disease processes are needed.
About the LEADERSHIP study
The LEADERSHIP study is a double-blind, placebo-controlled, Phase II clinical trial investigating AQX-1125′s ability to reduce inflammation and pain in approximately 70 female patients with BPS/IC. The primary objective is to measure the difference in the change from baseline in the mean daily bladder pain score based on an 11-point numeric rating scale (NRS) at two, four, and six weeks recorded by eDiary. The trial is being conducted at community and academic sites across Canada.
If you are a BPS/IC patient interested in participating in the LEADERSHIP study, please visit http://www.cmxres.com.
For more information on the LEADERSHIP study, please visit http://www.clinicaltrials.gov.