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Intra-Cellular Therapies Reports Positive Final Results of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia
Date:3/10/2009

-3.75 0.47 5.53 8.94 p = 0.002 WASO -1.86 -12.69 -14.31 -33.22 p = 0.001 TST -9.22 4.17 0.56 27.61 p < 0.001 Total Time Awake 9 -4.08 -1.42 -28.31 p < 0.001 Sleep Efficiency -1.94 0.82 0.14 5.80 p < 0.001

The effects of ITI-007 on SWS are likely due to the ability of ITI-007 to potently antagonize 5HT2A receptors at low doses. The expanded pharmacological effects that emerge at higher doses contributed to the robust decreases in WASO at the 10 mg dose of ITI-007. The magnitude of this effect on WASO is larger than that seen with selective 5HT2A receptor antagonists and may be attributed to additional beneficial pharmacology that emerges at the higher doses tested. The highest dose tested (10 mg) is thought to fully occupy 5HT2A receptors while adding incremental amounts of dopamine receptor and serotonin reuptake transporter (SERT) occupancy. Together, these data suggest that ITI-007 induces a novel pattern of sleep improvement.

Doses of ITI-007 were safe and well-tolerated in patients with insomnia. The majority of the subjects experienced no adverse events (58%) or adverse events that were considered unrelated or unlikely related to study treatment (26%). Only 3 of the 19 subjects (16%) experienced an adverse event considered possibly related to study treatment; these were mild to moderate, were not dose-related and all resolved. No serious adverse events were reported. Importantly, ITI-007 did not impair next day cognition as measured by a battery of cognitive testing in the morning upon waking. ITI-007 caused no significant impairment of attention, vigilance, information processing or declarative memory as measured by the Leeds Psychomotor Battery, Digit Symbol Substitution Test or Word Pair Associates Test. Pharmacokinetic analyses
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SOURCE Intra-Cellular Therapies, Inc.
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