US-based Intra-Cellular Therapies has reported additional results from a Phase I/II clinical trial (ITI-007-200) of ITI-007, in healthy geriatric subjects (trial Part 1) and in patients with dementia, including Alzheimer’s disease (AD) (trial Part 2).
The trial is designed to evaluate the safety, tolerability and pharmacokinetics of low doses of ITI-007 in these patients, while it marks an important milestone in the expansion of the company’s central nervous system (CNS) platform.
Secondary endpoints of the trial explored the effects of ITI-007 on measures of cognitive function.
The results show that ITI-007 is safe and well-tolerated across a range of low doses, has linear- and dose-related pharmacokinetics and improves cognition in elder patients.
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, behaviours which often lead to early institutionalisation.
"We believe ITI-007 will reduce the behavioural disturbances associated with dementia in the elderly with a beneficial effect on cognition and with a favourable safety profile that does not increase the risk of cardiovascular events or falls due to motor impairment."
In 2015, the company intends to start a Phase II clinical programme evaluating ITI-007 in patients with behavioural disturbances associated with dementia and related disorders, including AD.
The Phase I/II ITI-007-200 trial was conducted in two parts; the first part was a randomised, double-blind, placebo-controlled multiple ascending dose evaluation of ITI-007 in healthy geriatric subjects.
In each of three groups in Part 1 of the trial, around ten subjects were randomised 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 randomised to receive 9mg ITI-007 or placebo orally once a day in the evening for seven days.