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news.Intra-Cellular Therapies has released additional results from ITI-007-200, a Phase I/II clinical trial of its lead drug candidate, ITI-007, in healthy geriatric subjects (trial Part 1) and in patients with dementia, including Alzheimer's disease (trial Part 2).
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The trial was designed to evaluate the safety, tolerability and pharmacokinetics of low doses of ITI-007 in these patients.
According to the company, secondary endpoints of the trial explored the effects of ITI-007 on measures of cognitive function.
The data show that ITI-007 is safe and well-tolerated across a range of low doses, has linear- and dose-related pharmacokinetics as well as improves cognition in elders.
Intra-Cellular Therapies chief executive officer and chairman Dr Sharon Mates said: "Cognitive deficits are a hallmark of dementia, and the data presented today provide clinical evidence that ITI-007 can improve cognitive measures of learning and memory.
"Patients with dementia also suffer from agitation, heightened aggression, depression, sleep disorders, ‘sundowning’ and psychosis, behaviors which often lead to early institutionalization.
"We believe ITI-007 will reduce the behavioral disturbances associated with dementia in the elderly with a beneficial effect on cognition and with a favorable safety profile that does not increase the risk of cardiovascular events or falls due to motor impairment.
"We believe the broad therapeutic benefit of ITI-007 will substantially improve patient lives and the lives of their families and caregivers."
The Phase I/II ITI-007-200 trial was carried out in two parts; the first part was a randomized, double-blind, placebo-controlled multiple ascending dose evaluation of ITI-007 in healthy geriatric subjects.
In each of three groups in Part 1, around ten subjects were randomized to receive ITI-007 or placebo orally once daily in the morning for seven days; doses of ITI-007 up to and including 30mg were evaluated in those three groups.
The trial’s Part 2 included eight patients with dementia and they were randomized to receive 9mg ITI-007 or placebo orally once a day in the evening for seven days.
The company intends to begin a Phase II clinical program in 2015 to evaluate ITI-007 in patients with behavioral disturbances associated with dementia and related disorders, including AD.