History

Company Founding

Aquinox Pharmaceuticals, Inc. commenced operations in 2006 as a spin-off from the University of British Columbia, the BC Cancer Agency and the Vancouver Coastal Health Research Institute, all organizations with outstanding reputations for world-class research. Our scientific co-founders discovered the enzyme called SH2-containing inositol-5'-phosphatase-1 (known as "SHIP1"), as well as compounds to modulate this enzyme. SHIP1 is expressed primarily in haematopoeitic-derived cells and, when activated, balances the normal activity of the PI3K pathway, a key pathway that when engaged promotes cell growth, proliferation, survival, and immune cell function including inflammation. Thus, SHIP1 activators, like those we are developing, enhance the body’s natural regulation of this pathway to reduce overactive immune cells and have the potential to treat a broad range of inflammatory diseases and cancer.

Financing

From 2007 through to 2013 Aquinox raised approximately $57.5M in successive rounds of private financing with significant participation by leading VCs and biotech investors including Ventures West, Lion’s Capital and Baker Brothers as well as the investment arms of major pharmaceutical companies including Johnson & Johnson Development Corporation, Pfizer Venture Investments and Pharmstandard International.  On March 12, 2014 shares in Aquinox became publically listed on NASDAQ (AQXP) through an IPO that raised gross proceeds of $53M and was led by the investment banking syndicate of Jefferies, Cowen & Co. and Canaccord Genuity. On September 16, 2015 Aquinox closed a $98M public offering led by the investment banking syndicate of Leerink, Canaccord, Guggenheim and Needham and in September of 2017 closed a $75.4M public offering led by the investment banking syndicate of Leerink, Canaccord, Guggenheim and Needham.

Clinical Development

The proceeds from Aquinox’s early private financings were used to advance our lead clinical candidate, AQX-1125, through a three-part Phase 1 trial in healthy adults and into two proof-of-concept clinical trials with AQX-1125; both proof-of-concept trials were successful and demonstrated the anti-inflammatory properties of AQX-1125 previously seen in preclinical studies. Aquinox then completed Phase 2 clinical trials with AQX-1125 in in chronic obstructive pulmonary disease (COPD), atopic dermatitis and interstitial cystitis / bladder pain syndrome (IC/BPS). Results from the Leadership 201 trial with AQX-1125 in IC/BPS demonstrated a positive trend in the primary endpoint and statistically significant changes on secondary endpoints including both pain and urinary symptoms. Aquinox is now focusing on the advancement of AQX-1125 through Phase 3 trials having initiated the LEADERSHIP 301 trial in September of 2016. We will continue to explore additional disease indications for AQX-1125 and our rich library of new compounds in preclinical development. 

LEADERSHIP 201

In August of 2015 Aquinox announced full results from its LEADERSHIP 201 Phase 2 clinical in IC/BPSBPS/IC, which is a chronic inflammatory disease of the bladder characterized by bladder pain and increased urinary urgency and/or frequency that may affect as many as 12 million individuals in the United States alone. The LEADERSHIP trial was a double-blind, placebo-controlled, clinical trial that enrolled 69 women and investigated AQX-1125's ability to reduce bladder pain and urinary symptoms in patients with BPS/IC. The trial was conducted at clinical sites across Canada and the United States. Positive results from the LEADERSHIP trial support advancement of AQX-1125 into pivotal trials in BPS/IC. Results from the Leadership 201 trial with AQX-1125 in IC/BPS demonstrated a positive trend in the primary endpoint and statistically significant changes on secondary endpoints including both pain and urinary symptoms.

LEADERSHIP 301

In September of 2016 dosed the first patient in its LEADERSHIP 301 Phase 3 trial with AQX-1125 in IC/BPS. The LEADERSHIP 301 trial 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 AQX-1125 to reduce bladder pain in patients with IC/BPS. The primary endpoint of the LEADERSHIP 301 trial is to measure 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. Secondary 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 AQX-1125. 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 2018

FLAGSHIP

In December of 2013, Aquinox commenced its second Phase 2 clinical trial of AQX-1125 in COPD exacerbations. COPD is a lung disease characterized by progressive loss of lung function and chronic inflammation of the airways that affects up to an estimated 600 million people worldwide. The FLAGSHIP trial was a double-blind, placebo-controlled, Phase 2 clinical trial that will enroll approximately 350-400 patients with moderate to severe COPD that have suffered a recent exacerbation, or are just experiencing one, and AQX-1125 was investigated to determine its ability to reduce the symptoms and recurrence of exacerbations. The trial was being conducted at clinical sites across Northern Europe, Australia, New Zealand and the United States. Results from the FLAGSHIP trial reported on July 9, 2015 demonstrated no difference in effect between AQX-1125 and placebo and Aquinox has suspended further development of AQX-1125 for COPD.

KINSHIP

In December of 2014 Aquinox initiated a Phase 2 clinical in atopic dermatitis, which is a chronic inflammatory disease characterized by chronically inflamed skin that affects an estimated 17.8 million Americans.The KINSHIP trial is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 clinical trial investigating the ability of AQX-1125 to reduce characteristic symptoms in approximately 50 patients with mild to moderate atopic dermatitis. The trial was conducted at investigator sites across Canada. Results from the KINSHIP trial reported on November 2, 2015 demonstrated no difference in effect between AQX-1125 and placebo and Aquinox has suspended further development of AQX-1125 for atopic dermatitis.