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Aquinox Initiates Two Phase IIa Clinical Studies in Airway Inflammation Following Successful Phase I
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Aquinox Pharmaceuticals Inc. has announced that it has initiated two Phase IIa clinical studies. Both studies will measure AQX-1125's ability to prevent inflammation and are scheduled to complete during 2012.
The two Phase IIa studies are being conducted at centers of excellence in the United Kingdom.
The first study will evaluate a single dose of AQX-1125 in a randomized, double-blind, placebo-controlled trial in mild and moderate asthmatic patients exposed to an allergen known to induce an asthmatic attack.
In the second study, AQX-1125 will be given in a randomized, double-blind, placebo-controlled fashion at one of two doses to volunteers exposed to an environmental inflammatory stimulus.
In each study, subjects will be administered drug orally once-daily for seven days with a key endpoint including AQX-1125's ability to reduce inflammatory cells and markers in sputum - indicators of the drug's anti-inflammatory properties.
The studies will also continue to evaluate AQX-1125's safety and residence time in the blood (pharmacokinetics).
Earlier in the year, Aquinox successfully completed a Phase I clinical study assessing the safety, tolerability, absorption, and pharmacokinetics of AQX-1125.
In this study, AQX-1125 was rapidly absorbed and exhibited a dose-proportional pharmacokinetic profile over the range of doses tested with a half-life of approximately 22 hours.
Furthermore, the drug's Adverse Effects (AE) profile was generally unremarkable with mild gastrointestinal upset being the only dose-related observation.
"The results of the Phase 1 study demonstrated that AQX-1125 was well tolerated at all dose levels tested," said Dr. David Chernoff, Chief Medical Officer of Aquinox.
Dr. Chernoff continued, "The drug is rapidly absorbed after oral administration and has desirable pharmacokinetic properties making it suitable for once-daily oral dosing. Overall, the results support continued development of this novel oral anti-inflammatory drug."
The Phase I study was conducted in three parts: The first part was a double-blind, placebo-controlled, single ascending dose study evaluating safety and pharmacokinetics with 16 healthy volunteers.
This was followed by a double-blind, placebo-controlled, multiple ascending dose study further evaluating safety and pharmacokinetics following ten consecutive days of dosing with an additional 24 healthy volunteers.
The final part was a double-blind, placebo-controlled, study of the effects of food on the absorption of the drug in 12 additional healthy volunteers.
