Aquinox Pharmaceutical shared its Phase 3 Leadership 301 clinical trial with oral rosiptor (AQX-1125) for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) failed to meet its primary endpoint resulted in a major share price decrease.
With previous clinical trials and preclinical development for each potential drug it’s hard to explain why some drug candidates fail at the final stage, but it nearly always proves to make a big impact on the company’s share price.
This was the case on Wednesday (June 27), for Aquinox Pharmaceutical (NASDAQ:AQXP) when the company shared its Phase 3 Leadership 301 clinical trial with oral rosiptor (AQX-1125) for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) failed to meet its primary endpoint.
As a result, the company’s share price decreased by a staggering 84.72 percent from US$15.31 to $2.34 Wednesday.
“These results support halting all further development activities with rosiptor,” David Main, CEO of Aquinox said in the press release. “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.”
Main added the trial was “robust and well-conducted” and the company believes the results are definitive. After conducting a number of sensitivity subpopulation and secondary endpoint analyses, none showed a benefit over the placebo in maximum daily bladder pain, which was the primary endpoint.
The Leadership 301 trial enrolled 433 participants which received 100 or 200 mg of rosiptor or the placebo. The participants enrolled were similar to the Phase 2 trial. The leading clinical research centers for the trial were in the US, Canada and Europe.
IC/BPS is a debilitating condition where patients have chronic bladder pain and urinary symptoms, which may be recurring pain, pressure and/or discomfort perceived to be related to the urinary bladder. About one million out of the 5.5 million adults in the US with IC/BPS symptoms have been diagnosed or are receiving treatment.
During the conference call regarding the news about the top line results, Main confirmed the company will halt its Phase 2 proof-of-concept trial evaluating the efficacy and safety of rosiptor in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Main added the company doesn’t find it “appropriate to continue exposing patients to rosiptor,” due to little confidence of benefits from the drug.
Aquinox works on therapeutics for conditions marked by inflammation, inflammatory pain and blood cancers. The company focuses on generating compounds for use in IC/BPS and other inflammatory indications. It has also initiated a program to evaluate the potential for SHIP1 activators in blood cancers.
Because, Aquinox’s share price took a hit from the poor outcome of its clinical trial, Cantor Fitzgerald analyst William Tanner downgraded the company to a “hold” after the announcement.
TipRanks predicts the company could have a high of $23.50 over a 12-month period and a low of $22.00, according to the most recent analyst notes.
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Securities Disclosure: I Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.