11.08.2015 15:09:29

The Rise, Fall And Steep Climb Of Aquinox Pharma...

(RTTNews) - Shares of Aquinox Pharmaceuticals Inc. (AQXP) have been red-hot in the last two trading days, up an eye-popping 3014%.

When we profiled Aquinox on October 15, 2014, the stock was trading around $6. With not much change in the stock price, Aquinox wrapped up the year at $7.50 per share.

The company started 2015 on a high note, announcing important milestones.

On February, 2, 2015 Aquinox announced that it has reached its target enrollment in a phase II study of AQX-1125 for the treatment of chronic obstructive pulmonary disease (COPD) following a recent exacerbation. The trial, dubbed FLAGSHIP, enrolled approximately 400 unstable patients with moderate to severe COPD.

Exactly a month later - March 2, 2015 - the company announced that it has reached its target enrollment in a phase II study evaluating AQX-1125 for the treatment of bladder pain syndrome/interstitial cystitis (BPS/IC). The trial, dubbed LEADERSHIP, had 68 patients enrolled in it.

With two phase II trials evaluating AQX-1125 in different indications reaching the enrollment target, Aquinox began to catch investors' eyes. By March 11, 2015, the stock had climbed to a high of $12.28, but only to reverse trend in the successive months.

On May 4, 2015, the company announced that it has reached its target enrollment of 50 patients in a phase II trial of AQX-1125 for the treatment of atopic dermatitis, dubbed KINSHIP. The stock closed at $6.72 that day.

Then followed a couple of bad news for investors.

On June 25, 2015, Aquinox announced that while there was a reduction in pain for patients with bladder pain syndrome/interstitial cystitis on AQX-1125 compared to those patients on placebo following six weeks of treatment, the difference did not reach statistical significance in the LEADERSHIP trial.

Nevertheless there was a positive trend in reduction of pain with AQX-1125 compared to placebo. Approximately 49% of patients receiving AQX-1125 demonstrated a 2-point or greater reduction in pain compared to 34% of patients receiving placebo. So the news did no damage to the share price, and Aquinox closed that day's trading at $7.27.

But on July 9, 2015, with the company announcing that its phase 2 FLAGSHIP clinical trial of AQX-1125 in chronic obstructive pulmonary disease patients has failed to demonstrate efficacy, the shares took a huge hit - tanking 67% to close at $2.13 that day, and fell further in the succeeding days.

On August 6, 2015, the company announced that several statistically significant secondary endpoints were achieved in the LEADERSHIP trial, including a statistically significant 1.3 point greater reduction over placebo on maximum daily pain at six weeks and a statistically significant 4.4 point greater reduction over placebo on the O'Leary Sant Symptom Scale at six weeks compared to placebo.

Commenting on the results, David Main, President and CEO of Aquinox said, "Consistently positive results from multiple secondary endpoints have strengthened our confidence in further development of AQX-1125 for BPS/IC. The encouraging effect of AQX-1125 observed on the primary endpoint of reduction in pain together with several statistically significant secondary endpoints, underscore the potential of AQX-1125 as a once daily, oral therapy for this debilitating disease."

Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC), which affects men and women of all ages, is a chronic urinary bladder disease characterized by erosion of the lining and chronic inflammation of the bladder, pelvic pain and increased urinary urgency and/or frequency. An estimated 14 million people in the United States are affected by BPS/IC.

Currently, there is no known cure for BPS/IC, and the current therapies that are available and those in development are focused solely on symptomatic relief of the disease. Elmiron, the only FDA-approved oral therapy, helps to temporarily restore the bladder lining.

But AQX-1125 is designed to address not just the urinary symptoms but also the chronic pain underlying BPS/IC.

The encouraging primary endpoint results and the positive secondary endpoint results of the LEADERSHIP trial have caught the eye of investors who are scooping the company's shares aggressively.

Ever since the company provided an update to the LEADERSHIP trial results, the shares have gained as much as over 3000%. The stock touched an intra-day high of $55.75 yesterday, before closing the day at $18.88, up 81.19%.

Another catalyst to watch out for is the KINSHIP trial data. The company now anticipates top line data from the KINSHIP trial in Q4 2015, a quarter earlier than previously thought.

Will the Aquinox mojo continue? Stay tuned...

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