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ARTICLE | Clinical News

CX1739: Phase II data

February 7, 2011 8:00 AM UTC

Top-line data from a double-blind, placebo-controlled Phase II trial in 20 adults with moderate to severe obstructive sleep apnea showed that a single oral dose of 900 mg CX1739 did not reduce mean apnea-hypopnea index (AHI) score, defined as the frequency of apnea or hypopnea events per hour of sleep, from baseline. Cortex said the interpretation of the results was "complicated" by a reduced sleep time during the night following treatment. In an AHI responder analysis, defined as a >40% reduction in AHI score, 3 patients receiving CX1739 were identified as responders vs. 0 patients receiving placebo. Additionally, CX1739 significantly reduced mean apnea-hypopnea time (AHT), defined as the cumulative time of all apneas and hypopneas over the night, between baseline and the treatment night vs. placebo (21 minutes vs. a 12 minute increase, p<0.05). In an AHT responder analysis, defined as a >40% reduction in AHT score, 5 patients receiving CX1739 were identified as responders vs. 0 patients receiving placebo.

CX1739 also significantly increased mean blood oxygen saturation (p<0.01), increased minimum blood oxygen saturation (p<0.001), reduced the total time that blood oxygen saturation was <90% (p<0.01), and reduced the number of times per hour of sleep time that blood oxygen saturation was <90% vs. placebo (p<0.05). CX1739 did significantly reduced sleep efficiency, defined as the percent of time asleep while in bed for the 8 hour session, by about 20% vs. placebo (p<0.001), but the level of daytime sleepiness as determined by the Clinical Global Impressions Daytime Vigilance test was unaffected by treatment. Cortex said CX1739 was safe, but appeared to be near the limits of tolerability when administered just before bedtime. There were no serious adverse events and no clinically relevant changes in vital signs, cardiovascular or other safety assessments. ...