- Phase II Results Accepted for Publication in Journal of Urology
VANCOUVER, British Columbia, May 05, 2016 (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, today announced the selection of three abstracts for moderated poster sessions at the upcoming 111th American Urological Association (AUA) Annual Meeting to be held in San Diego, CA from May 6-10, 2016. Dr. Curtis Nickel will present two posters describing the efficacy, pharmacokinetics and safety results of the Phase 2 LEADERSHIP 201 trial with AQX-1125 in patients with IC/BPS. A third poster will present results from non-clinical studies that supported our development of AQX-1125 in IC/BPS.
Aquinox also announced that results from the LEADERSHIP 201 trial have been accepted for publication in an upcoming issue of the peer-reviewed Journal of Urology. The publication, also lead authored by Dr. Nickel, is entitled “A Phase II Study of Efficacy and Safety of a Novel, Oral SHIP1 Activator, AQX-1125, in Subjects with Moderate to Severe Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)”.
“These poster presentations at AUA and our publication in the Journal of Urology underscore the strength and vital importance of the results from our LEADERSHIP 201 trial, not only to urologists with very limited effective options to treat these patients, but also to the patients themselves who continue to suffer,” said Dr. Stephen Shrewsbury, Senior Vice President of Clinical Development and Chief Medical Officer at Aquinox. “The enthusiastic response we have received from the urological community following the release of the LEADERSHIP 201 results further supports our plans to advance into our first Phase 3 clinical trial with AQX-1125 in IC/BPS this year.”
The LEADERSHIP 201 trial investigated the ability of oral, once daily AQX-1125 to reduce pain and improve urinary symptoms in female patients with IC/BPS. The Phase 2 trial demonstrated improvements in average (p = 0.06) and maximum (p = 0.04) daily pain at six weeks based on an 11-point numeric rating scale (NRS) as well as improved urinary symptoms including reduced voiding frequency (p = 0.04). Aquinox announced primary and secondary endpoint results from the LEADERSHIP 201 trial on June 25, 2015 and August 6, 2015, respectively. Full results from the LEADERSHIP 201 trial with management commentary were presented at Aquinox’s R&D Day in New York on October 7, 2015, a video webcast of which can be found on Aquinox’s corporate website at http://investor.aqxpharma.com/events.cfm.
All posters will be available for viewing on the “Selected Publications” page Aquinox’s corporate website at http://aqxpharma.com/content/selected-publications. The Journal of Urology publication is currently available online at http://www.jurology.com/article/S0022-5347(16)03368-1/abstract with print copy anticipated at a later date.
About Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
IC/BPS 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. IC/BPS is estimated to affect between 5 and 12 million people in the United States. Most IC/BPS 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 IC/BPS. 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 signalling 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 for once daily oral administration in multiple preclinical studies and seven completed clinical trials. Aquinox completed a successful Phase 2 clinical trial with AQX-1125 for the treatment of IC/BPS in 2015 and anticipates initiation of a Phase 3 trial with AQX-1125 in IC/BPS in 2016.
About the LEADERSHIP 201 Trial
The LEADERSHIP 201 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 IC/BPS. The primary endpoint was to measure the difference in the change from baseline in the average daily bladder pain score based on an 11-point numeric rating scale (NRS) at six weeks recorded by electronic diary. Results demonstrated a positive trend in the primary endpoint and statistically significant changes on secondary endpoints including both pain and urinary symptoms. A total of 69 subjects were enrolled. For more information on the LEADERSHIP 201 trial, please visit http://www.clinicaltrials.gov.
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. With a successful Phase 2 clinical trial completed in 2015, Aquinox plans to initiate a Phase 3 trial in 2016 with AQX-1125 for treatment of IC/BPS. 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 planning for, and timing of, our planned Phase 3 clinical trials in IC/BPS; potential market opportunities for AQX-1125; and our projected cash position. 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: our ability to enroll patients in our clinical trials at the pace that we project; as an organization, we have never conducted a pivotal clinical trial before; the size and growth of the potential markets for AQX-1125 or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of AQX-1125 or any future product candidates; reaching agreement on design of pivotal trials with regulatory authorities and our expectations regarding the potential safety, efficacy or clinical utility of AQX- 1125 or any future product candidates. 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 Annual Report on Form 10-K for the year ended December 31, 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.
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