Acadia's ACP-103 increases deep sleep in insomnia

By Lisa Kerner

Erie, Pa., April 19 - Acadia Pharmaceuticals Inc. said top-line study results demonstrated that ACP-103 induced a dose-related increase in slow wave (deep) sleep and had a positive impact on measures for sleep maintenance, including decreases in the number of awakenings after sleep onset and in the time awake after sleep onset.

The top-line results are from a clinical study of the effect of ACP-103 on deep (slow wave) sleep in 45 healthy older volunteers.

ACP-103 is Acadia's proprietary serotonin 5-HT2A inverse agonist.

"These data provide a proof-of-concept of the ability of ACP-103 to improve the quality of sleep by increasing slow wave sleep," chief executive officer Uli Hacksell said in a company news release.

"This suggests that ACP-103 has potential as a novel treatment for sleep maintenance insomnia."

Sleep maintenance insomnia is the inability to stay asleep or to resume sleep after waking.

In the double-blind, placebo-controlled study, subjects were randomized to one of five treatment arms, including a placebo and four different doses (1 mg, 2.5 mg, 5 mg and 20 mg) of ACP-103.

Each group received a placebo or ACP-103 once daily for 14 consecutive days. All subjects underwent a two-night screening and baseline polysomnography (PSG) evaluation, plus PSG measurements on study days one and 13.

Other testing measures included the Continuous Performance Test to assess daytime functioning, blood samples, and a positron emission tomography study to measure 5-HT2A brain receptor occupancy.

The PSG data demonstrated that once-daily administration of 5 mg and 20 mg of ACP-103 induced statistically significant increases in slow wave sleep, defined by the time spent in stage 3 and stage 4 sleep, the company said.

ACP-103 was safe and well tolerated, with no serious adverse events reported.

Acadia said it is also developing ACP-103 as a therapy for treatment-induced dysfunctions in patients with Parkinson's disease and as an adjunctive therapy for schizophrenia.

Acadia is a San Diego-based biopharmaceutical company specializing in novel treatments for central nervous system disorders.

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