US-based Cortex Pharmaceuticals has announced encouraging results from its exploratory clinical study of Ampakine compound CX1739 in patients with sleep apnoea.
The study found that selected oxygen saturation parameters were statistically improved by one dose of CX1739, but the interpretation of these results was complicated by a reduced sleep time during the night following drug treatment.
CX1739 did not reduce the apnoea/hypopnoea index – the frequency of apnoea or hypopnoea events per hour of sleep –but significantly reduced the time of all apnoeas and hypopnoea between the baseline and the treatment night by an average of 21 minutes, compared to an increase of 12 minutes in the placebo group.
The double-blind and placebo-controlled design-study enrolled 20 adults with moderate-to-sever obstructive sleep apnoea, 16 of which took a single dose of the drug and four received a matching placebo for one night.
Adrian Williams, professor of sleep medicine at King’s College London and the trials prinicipal investigator commented: “The results from this pilot study are encouraging, and warrant undertaking a larger clinical study to better understand the sleep apnoea patient population most responsive to the treatment of CX1739.”
Cortex aimed to further explore the safety and tolerability in the sleep apnea population and to asses the efficacy of CX1739.
CX1739 was safe but the dose appeared to be near the limits of tolerability when administered just before bedtime to the moderately overweight, middle-aged group of sleep apnoea subjects.
There were no serious adverse events and no clinically relevant changes in vital signs, cardiovascular or other safety assessments.
