August 25, 2015 – Aquinox Pharmaceuticals, Inc
VANCOUVER, British Columbia, Aug. 25, 2015 (GLOBE NEWSWIRE) — Aquinox Pharmaceuticals, Inc. (“Aquinox”) (NASDAQ:AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, announced that an abstract from the LEADERSHIP Phase 2 clinical trial with AQX-1125 in bladder pain syndrome/interstitial cystitis (BPS/IC) has been accepted for oral presentation at the 2015 ESSIC Annual Meeting to be held in Rome, Italy from Thursday, September 17th to Saturday, September 19th.
Aquinox will present in the first Abstract Session scheduled for September 18th at 12:00 PM local time. The abstract is under embargo until after the session; accordingly, no details of the abstract may be shared in advance. Following the presentation, the abstract together with data slides will be available at www.aqxpharma.com. The abstract is entitled, “Safety and Efficacy of AQX-1125 in Interstitial Cystitis/Bladder Pain Syndrome – Results of the Phase 2 LEADERSHIP Trial.”
In the LEADERSHIP trial, patients treated with AQX-1125, compared to placebo, demonstrated a positive trend in the primary endpoint of average daily pain over 6 weeks as well as significant improvements in additional, predetermined secondary endpoints of pain and urological symptoms. AQX-1125 was well tolerated, with adverse event rates comparable to placebo. Additional details and results from the LEADERSHIP trial can be found at www.aqxpharma.com.
“We are very pleased to share our data demonstrating the potential clinical benefit for BPS/IC patients treated with once daily, oral AQX-1125, with international experts at the ESSIC Annual Meeting,” said Dr. Stephen Shrewsbury, Senior VP Clinical Development & CMO of Aquinox. “The invitation for a podium presentation allows us to provide a comprehensive review of the results from the LEADERSHIP trial.”
About the LEADERSHIP Trial
The LEADERSHIP trial was a multicenter, randomized, double-blind, placebo-controlled, Phase 2 clinical trial investigating the ability of 200 mg oral, once daily AQX-1125 to reduce pain in female patients with bladder pain syndrome/interstitial cystitis. The primary endpoint was 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 six weeks recorded by electronic diary. The trial was conducted at investigative sites across Canada and the United States. A total of 69 subjects were enrolled. Primary and secondary endpoint results were announced on June 25th and on August 6th, 2015, respectively and can be found atwww.aqxpharma.com. For more information on the LEADERSHIP trial, please visit www.clinicaltrials.gov.
About Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC)
BPS/IC is a chronic inflammatory bladder disease characterized by pelvic pain and increased urinary urgency and/or frequency. For many 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, erosion of the bladder lining is thought to be a significant contributor. BPS/IC is estimated to affect between 5 and 12 million people in the United States. Most BPS/IC patients continue to suffer this debilitating condition, despite treatment with existing therapies. Most current therapies and those in development are focused solely on symptomatic relief of BPS/IC. Aquinox believes new and innovative therapies that target the underlying disease in order to reduce the chronic pain and urinary symptoms are needed.
AQX-1125, Aquinox’s lead drug candidate, is a small molecule activator of SHIP1, which is a regulating component of the PI3K cellular signaling pathway. By increasing SHIP1 activity, AQX-1125 accelerates a natural mechanism that has evolved to maintain homeostasis of the immune system and reduce immune cell activation and migration to sites of inflammation. AQX-1125 has demonstrated preliminary safety and favorable drug properties in multiple preclinical studies and clinical trials. Aquinox is currently developing AQX-1125 as an oral, once daily treatment in bladder pain syndrome/interstitial cystitis. In addition, Aquinox is exploring AQX-1125 for atopic dermatitis in its ongoing KINSHIP Phase 2 trial with top line data expected in Q4 2015.
About Aquinox Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Aquinox’s lead drug candidate, AQX-1125, is a small molecule activator of SHIP1 suitable for oral, once daily dosing. Aquinox has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1. For more information, please visit www.aqxpharma.com.
Cautionary Note on Forward-looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to: the clinical development of AQX-1125 and the potential market opportunities for AQX-1125 in BPS/IC. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the outcome of our on-going and anticipated clinical trials; the size and growth of the potential markets for AQX-1125; our ability to obtain and maintain regulatory approval of AQX-1125; and our expectations regarding the potential safety, efficacy or clinical utility of AQX-1125. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by Aquinox is contained in the company’s Quarterly Report Form 10-Q for the quarter ended June 30, 2015 filed with the Securities and Exchange Commission. Aquinox disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Senior Manager, Investor Relations, Aquinox Pharmaceuticals, Inc.
Phone: 604.629.9223 Ext. 109
Vice President, MacDougall Biomedical Communications