UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 27, 2018
Aquinox Pharmaceuticals, Inc.
(Exact name of Registrant as specified in its charter)
Delaware | 001-36327 | 98-0542593 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
450 887 Great Northern Way,
Vancouver, B.C.
Canada, V5T 4T5
(Address of principal executive offices, including zip code)
Registrants telephone number, including area code: (604) 629-9223
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 8.01 | Other Events. |
On June 27, 2018, Aquinox Pharmaceuticals, Inc. (the Company) issued a press release announcing results from its Phase 3 LEADERSHIP 301 clinical trial evaluating once-daily, oral rosiptor (AQX-1125) for the treatment of interstitial cystitis/bladder pain syndrome. The full text of the press release announcing such results is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this current report on Form 8-K and the press release attached as Exhibit 99.1 hereto is being furnished, but shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (Exchange Act), and is not incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01. | Financial Statements and Exhibits. |
(d) | Exhibits |
Number |
Description | |
99.1 |
Press Release of Aquinox Pharmaceuticals, Inc. dated June 27, 2018 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Aquinox Pharmaceuticals, Inc. | ||
By: | /s/ Kamran Alam | |
Name: | Kamran Alam | |
Title: | Chief Financial Officer |
Date: June 27, 2018
Exhibit 99.1
Aquinox Announces Topline Results of Phase 3 LEADERSHIP 301
Clinical Trial in Interstitial Cystitis/Bladder Pain Syndrome
VANCOUVER, British Columbia, June 27, 2018 Aquinox Pharmaceuticals, Inc. (Aquinox) (NASDAQ:AQXP) today announced that the Phase 3 LEADERSHIP 301 clinical trial evaluating once-daily, oral rosiptor (AQX-1125) for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) failed to meet its primary endpoint.
This is a disappointing result for Aquinox and for patients, said David Main, President and CEO of Aquinox. LEADERSHIP 301 was a robust and well-conducted trial, and we believe the results are definitive. We have conducted a number of sensitivity, subpopulation, and secondary endpoint analyses and none demonstrate a benefit of rosiptor over placebo. We had hoped to deliver better news to the patients and investigators that made the personal commitment to participate in the trial.
Main added, These results support halting all further development activities with rosiptor. We will be undertaking a thorough evaluation of our pipeline and other strategic options available to the company and will be in a position to provide further guidance later this year.
LEADERSHIP 301 enrolled 433 participants, including 341 female subjects who were randomized to receive rosiptor 100 mg or 200 mg, or placebo. The trial was balanced in terms of baseline characteristics between arms, and enrolled a population very similar to the prior Phase 2 trial. Rosiptor failed to achieve a statistically significant reduction in the mean change from Baseline at Week 12 in maximum daily bladder pain score compared to placebo (P=0.41) in the female subjects, which was the primary endpoint.
Rosiptor was generally well tolerated with the rate of adverse events during the 12-week treatment period similar to that of placebo and prior trials.
Aquinox will host a conference call later today for investors regarding this announcement with details as follows:
Conference Call and Webcast Details:
Date: June 27, 2018
Time: 8:30 AM EDT, 5:30 AM PDT
Toll-free: 1-866-357-7878
International: 1-315-625-3088
Audience Passcode 9289537
Webcast URL: https://edge.media-server.com/m6/p/n9fonzcy
The archived webcast will also be available on Aquinoxs website at www.aqxpharma.com approximately two hours after the event and will be available for replay for at least 30 days after the event.
About the LEADERSHIP 301 Trial
The LEADERSHIP 301 trial was a three-arm, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial assessing the effect of once-daily rosiptor (AQX-1125) on bladder pain and urinary symptoms in subjects with interstitial cystitis/bladder pain syndrome (IC/BPS). Subjects were enrolled at leading clinical research centers in the United States, Canada, and Europe.
About Interstitial Cystitis/Bladder Pain Syndrome
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a debilitating condition marked by chronic bladder pain and urinary symptoms. Patients may experience recurring pain, pressure, and/or discomfort perceived to be related to the urinary bladder as well as urinary frequency, urgency, and/or nocturia. The pain often worsens upon bladder filling and may be relieved upon bladder emptying. Many patients living with IC/BPS report that it takes a physical, emotional, and psychological toll, greatly impacting employment and social and intimate relationships. There are currently few FDA approved and/or effective treatment options for IC/BPS. Only about 1M of the 5.5M adults in the United States with symptoms of IC/BPS have been diagnosed or are receiving treatment.
About Aquinox Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a pharmaceutical company developing novel therapeutics for conditions marked by inflammation, inflammatory pain, and blood cancers. 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, including those relating to evaluation of our pipeline and strategic options. 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: clinical drug development is a lengthy and expensive process with an uncertain outcome; our ability to identify or acquire additional clinical candidates, our ability obtain and maintain regulatory approval for any future product candidates and the potential safety, efficacy or clinical utility of 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 companys Annual Report on Form 10-K for the year ended December 31, 2017, and subsequent reports, 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.
Investor Contact:
Brendan Payne Associate Director, Investor Relations Aquinox Pharmaceuticals, Inc. 604.901.3019 ir@aqxpharma.com |
Media Contact:
Dan Boyle Orangefiery 818.209.1692 dan@orangefiery.com |
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