June 25, 2015
By Alex Keown, BioSpace.com Breaking News Staff
VANCOUVER, British Columbia – An experimental bladder pain syndrome/ interstitial cystitis drug being developed by immuno-oncology drugmaker Aquinox Pharmaceuticals, Inc. failed to meet its statistical endpoint during a mid-stage clinical trial, the company announced this morning.
AQX-1125, Aquinox’s lead drug candidate, did not diminish pain in trial patients compared to those who took a placebo during a six week period of treatment, the company said. However, during a Phase I trial, the drug did show promise in treating pain, David Main, president and chief executive officer of Aquinox said in a statement.
“Almost half of patients treated with AQX-1125 achieved a 2-point or greater reduction in pain,” Main said of the earlier trial.
The company stock was trading lower this morning at $7.25 per share, down from a high of $7.62 per share.
AQX-1125, an oral once-daily medication, is a small molecule activator of SHIP1, a regulating component of the PI3K cellular signaling pathway. By increasing SHIP1activity AQX-1125 is designed to maintain homeostasis of the immune system and reduce immune cell activation and migration to sites of inflammation of those suffering bladder pain syndrome/ interstitial cystitis.
Interstitial cystitis, or bladder pain syndrome, is a chronic condition causing bladder pressure, bladder pain and sometimes pelvic pain, according to the Mayo Clinic. The pain can be mild or severe. Individuals suffering from interstitial cystitis feel the need to urinate, even when the bladder is not full. It is estimated there are between five and 15 million people afflicted with interstitial cystitis in the United States. There is currently no cure for interstitial cystitis, although some physicians prescribe ibuprofen or aspirin for pain. One prescription medication approved to treat the pain is Janssen’s Elmiron, polysulfate sodium, which was approved by the U.S. Food and Drug Administration (FDA) in 1997.
In the Phase II LEADERSHIP trial for AQX-1125, the mean change in pain score for patients on 200mg oral, once daily AQX-1125 versus placebo, was a reduction of 2.4 versus 1.3 points, respectively, the company said. Approximately 49 percent of patients receiving AQX-1125 demonstrated a 2-point or greater reduction in pain compared to 34 percent of patients receiving placebo.
Secondary endpoints are currently being analyzed and will be reported at a future meeting. The Phase II trial was a one-to-one, double-blind, placebo-controlled, Phase II clinical trial investigating the ability of 200mg oral, once daily AQX-1125 to reduce pain in female patients with BPS/IC.
The trial included 69 patients. The primary endpoint of the mid-stage trial was to measure the difference in the change from baseline in the mean daily bladder pain score based on an 11-point numeric rating scale over a six week period of time.
While the drug failed to meet its statistical endpoint, the trial showed the drug was well tolerated by patients. The most frequently reported side effects were gastrointestinal disorders.
As Rumors Swirl About GlaxoSmithKline Bid, Who Could Suitors Be?
Rumors are swirling that Swiss-based Roche and U.S.-based Johnson & Johnson are eying the U.K. company for approximately $143 billion. But Roche and J&J aren’t the only companies though who have been thought could go after the elephant that is Glaxo.
Last month there was buzz that Pfizer Inc. was considering acquiring Glaxo, a year after it failed to acquire AstraZeneca PLC . Just this month over a third of respondents in a poll conducted by BioSpace believe that AstraZeneca PLC could be in the running to acquire struggling GlaxoSmithKline (GSK).
So BioSpace wants to ask our readers again what they predict for this new dealmaking bonanza. Will Glaxo go—and if so, to whom?
