– Trial Will Enroll Approximately 100 Male Subjects in the US and Canada –
VANCOUVER, Canada I June 11, 2018 I Aquinox Pharmaceuticals, Inc. (“Aquinox“) (NASDAQ:AQXP), a clinical-stage pharmaceutical company discovering and developing novel drug candidates to treat inflammation, inflammatory pain, and blood cancers, today announced initiation of dosing in ProShip, a Phase 2 proof-of-concept clinical trial evaluating the efficacy and safety of once-daily rosiptor in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), a urological condition characterized by chronic pelvic pain and voiding symptoms without evidence of urinary tract infection. There are currently no FDA approved treatment options for CP/CPPS.
The 12-week, randomized, double-blind, placebo-controlled ProShip clinical trial will evaluate rosiptor 200 mg versus placebo (randomized in a 1:1 ratio) in approximately 100 male subjects with CP/CPPS. The primary endpoint is the change in maximum daily pelvic pain from baseline to Week 12 versus placebo using an 11-point numeric rating scale. Secondary endpoints include relevant Patient Reported Outcomes (PROs) measuring pain, urinary frequency, and sexual dysfunction.
“Inflammation is believed to play a key role in CP/CPPS, supporting the evaluation of rosiptor for the treatment of this condition,” said Barbara Troupin, MD, MBA, Chief Medical Officer and Vice President of Clinical Development & Regulatory Affairs of Aquinox. “The design of ProShip builds on the learnings from our ongoing clinical trial program with rosiptor in interstitial cystitis/bladder pain syndrome (IC/BPS), another urological condition with significant unmet need defined by chronic pain and urinary symptoms.”
About Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
CP/CPPS is a urological condition characterized by chronic pelvic pain and voiding symptoms without evidence of urinary tract infection. Symptoms may include pelvic pain, urinary symptoms, and sexual dysfunction. Estimates suggest up to 5M males in the United States have symptoms of CP/CPPS yet only about 1M of these patients are diagnosed and treated. There are currently no FDA approved and/or effective treatment options for CP/CPPS, and few treatments in development.
About Aquinox Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company developing novel therapeutics for chronic urological conditions marked by inflammation and pain. Aquinox’s lead drug candidate, rosiptor (AQX-1125), is in Phase 3 development for the treatment of patients with interstitial cystitis/bladder pain syndrome (IC/BPS) and in a Phase 2 trial for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), debilitating conditions marked by chronic pain and urinary symptoms, for which there are currently few FDA approved and/or effective treatment options. Aquinox is focused on leveraging its library of novel compounds that activate SHIP1 to develop therapeutics for application in inflammation, inflammatory pain, and blood cancers. For more information, please visit www.aqxpharma.com.
SOURCE: Aquinox Pharmaceuticals
Post Views: 58
– Trial Will Enroll Approximately 100 Male Subjects in the US and Canada –
VANCOUVER, Canada I June 11, 2018 I Aquinox Pharmaceuticals, Inc. (“Aquinox“) (NASDAQ:AQXP), a clinical-stage pharmaceutical company discovering and developing novel drug candidates to treat inflammation, inflammatory pain, and blood cancers, today announced initiation of dosing in ProShip, a Phase 2 proof-of-concept clinical trial evaluating the efficacy and safety of once-daily rosiptor in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), a urological condition characterized by chronic pelvic pain and voiding symptoms without evidence of urinary tract infection. There are currently no FDA approved treatment options for CP/CPPS.
The 12-week, randomized, double-blind, placebo-controlled ProShip clinical trial will evaluate rosiptor 200 mg versus placebo (randomized in a 1:1 ratio) in approximately 100 male subjects with CP/CPPS. The primary endpoint is the change in maximum daily pelvic pain from baseline to Week 12 versus placebo using an 11-point numeric rating scale. Secondary endpoints include relevant Patient Reported Outcomes (PROs) measuring pain, urinary frequency, and sexual dysfunction.
“Inflammation is believed to play a key role in CP/CPPS, supporting the evaluation of rosiptor for the treatment of this condition,” said Barbara Troupin, MD, MBA, Chief Medical Officer and Vice President of Clinical Development & Regulatory Affairs of Aquinox. “The design of ProShip builds on the learnings from our ongoing clinical trial program with rosiptor in interstitial cystitis/bladder pain syndrome (IC/BPS), another urological condition with significant unmet need defined by chronic pain and urinary symptoms.”
About Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
CP/CPPS is a urological condition characterized by chronic pelvic pain and voiding symptoms without evidence of urinary tract infection. Symptoms may include pelvic pain, urinary symptoms, and sexual dysfunction. Estimates suggest up to 5M males in the United States have symptoms of CP/CPPS yet only about 1M of these patients are diagnosed and treated. There are currently no FDA approved and/or effective treatment options for CP/CPPS, and few treatments in development.
About Aquinox Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company developing novel therapeutics for chronic urological conditions marked by inflammation and pain. Aquinox’s lead drug candidate, rosiptor (AQX-1125), is in Phase 3 development for the treatment of patients with interstitial cystitis/bladder pain syndrome (IC/BPS) and in a Phase 2 trial for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), debilitating conditions marked by chronic pain and urinary symptoms, for which there are currently few FDA approved and/or effective treatment options. Aquinox is focused on leveraging its library of novel compounds that activate SHIP1 to develop therapeutics for application in inflammation, inflammatory pain, and blood cancers. For more information, please visit www.aqxpharma.com.
SOURCE: Aquinox Pharmaceuticals
Post Views: 58
