VANCOUVER, British Columbia, Dec. 15, 2017 (GLOBE NEWSWIRE) — Aquinox Pharmaceuticals, Inc. (“Aquinox”) (NASDAQ:AQXP) today announced that Lloyd Mackenzie has been promoted, effective immediately, to the newly created position of Chief Operating Officer and Vice President, R&D Operations.
“As we focus on executing the clinical development plan for rosiptor, our lead drug candidate, this is a critical role that will provide leadership for the execution phase of all of our research and clinical operations,” said David Main, President & CEO. “Lloyd has been a core member of the Aquinox team for nearly ten years. His strong cross-functional and project management leadership will be invaluable in our next phase of growth as he applies his demonstrated track record for getting complex projects completed on time and on budget.”
Mackenzie will be responsible for leadership of Aquinox’s functions of research, including preclinical operations, chemistry, manufacturing, and controls (CMC), quality assurance, and clinical operations.
“Lloyd and our Chief Medical Officer Barbara Troupin represent a dynamic leadership team for our product development efforts,” said Main. “As we move toward the completion of enrollment of the LEADERSHIP 301 trial in the first quarter of 2018, and anticipated top-line data in the third quarter of 2018, Lloyd and Barbara’s teams are focused on effective and efficient plans for the requirements ahead.”
Mackenzie, who joined Aquinox in 2008, has served as a vice president since 2013 and has overseen an increasing number of Aquinox functions, including technical operations, planning, early-stage development and CMC. Mackenzie was previously part of the pharmaceutical development team at QLT Inc. and was a senior research scientist at Inflazyme Pharmaceuticals Ltd., both based in Vancouver.
“I look forward to taking on this broader role of leadership of R&D operations,” said Mackenzie. “Dr. Troupin and I have formed a strong working relationship and I’m excited for us to lead an integrated approach to our product development strategies and execution.”
Mackenzie completed a bachelor of science degree in biochemistry from Simon Fraser University and conducted postgraduate studies in biochemistry and chemistry at the University of British Columbia. He is the author of 15 scientific publications and is an inventor on four patents, including patents relating to rosiptor.
About Rosiptor (AQX-1125)
Rosiptor, 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, rosiptor 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. Rosiptor has demonstrated preliminary safety and favorable drug properties for once daily oral administration in multiple preclinical studies and eight completed clinical trials.
About Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
IC/BPS is a chronic inflammatory bladder disease characterized by pelvic pain and increased urinary frequency and/or urgency. 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 millions of people in the United States and around the world. 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 to reduce the chronic pain and urinary symptoms are needed.
About the LEADERSHIP 301 Trial
The LEADERSHIP 301 trial, which commenced enrollment in September 2016, is a three-arm, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial investigating the ability of 200 mg and 100 mg oral, once daily rosiptor (AQX-1125) to reduce bladder pain in patients with IC/BPS. The primary endpoint of the LEADERSHIP 301 trial is the difference in the change from baseline in the maximum daily bladder pain score based on an 11-point numeric rating scale (NRS) at twelve weeks recorded by electronic diary. Additional endpoints include urinary symptoms, including frequency and nighttime awakenings to void, as well as measures of quality of life. The LEADERSHIP 301 trial also has an additional 52-week extension period, affording all participating patients the opportunity for treatment with rosiptor. An anticipated minimum of 300 female patients, up to a maximum of 600 patients including males, are currently being enrolled at clinical research centers in the United States, Canada and Europe. Top-line data from the LEADERSHIP 301 trial is anticipated in the third quarter of 2018.
About Aquinox Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a late clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Our primary focus is anti-inflammatory product candidates targeting SH2-containing inositol-5′-phosphatase 1, or SHIP1, which is a key regulator of an important cellular signaling pathway in immune cells, known as the PI3K pathway. Aquinox’s lead drug candidate, rosiptor (AQX-1125), is a small molecule activator of SHIP1 suitable for oral, once daily dosing. In September 2016, we began enrolling patients in a Phase 3 clinical trial of rosiptor in our lead indication, Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Other indications are under consideration for future investigation. 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: development of rosiptor (AQX-1125), LEADERSHIP 301 and availability of top-line data. 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 rosiptor (AQX-1125) or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of rosiptor (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 rosiptor 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 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.