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news.Biopharmaceutical company Arena has reported positive preliminary results from its Phase II clinical trial of its orally available drug candidate in patients with chronic insomnia.
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Compared to placebo, patients treated with APD125 experienced statistically significant improvements in measurements of sleep maintenance, or the ability to maintain sleep during the night after falling asleep. The improvements in measurements of sleep maintenance were achieved without any limiting next day cognitive effects.
The Phase II trial of APD125 was a randomized, double-blind, placebo- controlled study evaluating the safety and efficacy of nighttime dosing in patients with chronic insomnia. The trial evaluated standard measurements of sleep, such as wake after sleep onset (WASO), wake time during sleep (WTDS), number of awakenings, number of arousals, total sleep time and latency to persistent sleep, and enrolled a total of 173 male and female patients in about 25 clinical sites in the US.
Dr Thomas Roth of Henry Ford Hospital, said: “APD125 clearly has robust sleep maintenance properties. In the trial, APD125 consolidated sleep in ways that are not accomplished by any currently available drug.”
APD125 significantly improved several endpoints measuring improvements in sleep maintenance, including WASO and WTDS. WASO is the time spent awake from first sleep to the end of a standard prescribed eight hour sleep period. WTDS is the cumulative time spent awake from first falling asleep and last sleep: if a patient completes his or her sleep prior to the end of the eight hour sleep period, this time spent awake in bed is not included. As such, WTDS only accounts for time awake during a patient’s sleep period for that night.
Treatment with APD125 was well tolerated, with no reports of serious adverse events and no emerging safety findings as compared to placebo. No next day impairment of cognitive function was observed.
Dr William Shanahan, Arena’s chief medical officer, said: “We are very encouraged by the results from the Phase II trial, which demonstrate improved sleep maintenance with an excellent tolerability profile. We look forward to the continued development of APD125, and hope to bring a safe, efficacious and non-scheduled treatment to patients to help them maintain sleep and awake refreshed.”