Rosiptor and IC/BPS

IC/BPS

The American Urological Association (AUA) defines interstitial cystitis/bladder pain syndrome (IC/BPS) as “an unpleasant sensation (bladder pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six-weeks duration, in the absence of infection or other identifiable causes (click here).”5  

Patients with IC/BPS often report that the symptoms they experience adversely affect all major aspects of their lives6:

  • Feeling frustration, isolation, and hopelessness due to persistence of symptoms, struggles to receive a diagnosis, and/or failure of multiple treatments

  • Feeling blame or guilt, like they did something wrong to cause their pain

  • Thinking or having been told by healthcare providers that it’s “in their head”

  • Experiencing negative impacts on social and intimate relationships, employment, and physical and emotional health

There are an estimated 5.5 million adults in the United States who suffer from symptoms consistent with IC/BPS, however only ~ 1 million of these patients are diagnosed.  One reason for the low rate of diagnosis is that IC/BPS is a diagnosis of exclusion based on physical presentation of symptoms; healthcare providers (HCPs) rule-out other conditions, like OAB or Chronic Prostatitis, to rule-in IC/BPS. There is also no medical test or biomarker available today, which means that patients are often misdiagnosed and may experience a delay in diagnosis of months or years.  

Not only does diagnosis present challenges in the management of IC/BPS, but there are also few effective, and only two FDA approved, treatments available today. There is no one-size-fits-all treatment for IC/BPS and most patients will require a multi-modal treatment approach that includes diet/behavioral modification, stress management, and pelvic physical therapy, in addition to oral and/or intravesical treatments.7 Because there are few effective therapies available today, the AUA guideline on IC/BPS notes that patient enrollment in clinical research trials may also be an appropriate part of the treatment approach for patients.8

 

Rosiptor Clinical Trial Program for IC/BPS

Aquinox is committed to developing innovative therapies for IC/BPS as this is a condition with a true unmet need. Rosiptor (AQX-1125), our lead drug candidate, is in a Phase 3 clinical trial called LEADERSHIP 301 (click here), which is a 12-week, randomized, double blind, placebo controlled trial investigating the ability of once-daily, oral rosiptor (100 or 200 mg) to reduce bladder pain in subjects with IC/BPS. The LEADERSHIP 301 trial has an additional 52-week extension period, affording all enrolled subjects the opportunity for treatment with rosiptor.

LEADERSHIP 301 builds on the evidence from LEADERSHIP 201, a randomized, double blind, placebo controlled Phase 2 clinical trial, which investigated the ability of rosiptor (200 mg) to reduce bladder pain and urinary symptoms in female subjects with IC/BPS. Results from the Leadership 201 trial with rosiptor in IC/BPS demonstrated a positive trend in the primary endpoint and statistically significant changes in secondary endpoints including both pain and urinary symptoms. Phase 2 results in IC/BPS were published in the Journal of Urology in 2016, available here.

For more information about IC/BPS or clinical trials in IC/BPS visit:
Interstitial Cystitis Association (http://www.ichelp.org)

Interstitial Cystitis Network (http://www.ic-network.com)

www.ICBPSTips.com

www.clinicaltrials.gov  

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5 Hanno PM, Burks DA, Clemens JQ, et al. Diagnosis and treatment of interstitial cystitis/bladder pain syndrome. American Urological Association (AUA) Guideline. American Urological Association. 2014; 1-45.
6 Aquinox-sponsored Market Research, 2016-2017

7 Hanno PM, Burks DA, Clemens JQ, et al. Diagnosis and treatment of interstitial cystitis/bladder pain syndrome. American Urological Association (AUA) Guideline. American Urological Association. 2014; 1-45.
8 Hanno PM, Burks DA, Clemens JQ, et al. Diagnosis and treatment of interstitial cystitis/bladder pain syndrome. American Urological Association (AUA) Guideline. American Urological Association. 2014; 1-45.