Date: 2013-09-03
Type of information: Initiation of preclinical development
phase: 2a
Announcement: dosing of the first patient
Company: Elan (Ireland)
Product: ELND005
Action
mechanism: ELND005 is an orally bioavailable small molecule that is being investigated by Elan for multiple neuropsychiatric indications on the basis of its proposed dual mechanism of action, which includes Beta-amyloid anti-aggregation and regulation of brain myo-inositol levels. An extensive clinical program of Phase 1 and Phase 2 studies have been completed with ELND005 to support clinical development, including the published Phase 2 study ELND005-AD201 in AD. ELND005 is also being studied as a potential treatment of agitation and aggression in Alzheimer’s disease (Study ELND005-AG201) and as a maintenance therapy of Bipolar Disorder Type I (Study ELND005-BPD201).Excess activity of genes on chromosome 21, such as amyloid precursor protein (APP) and sodium-myo-inositol active transporter (SMIT), are thought to play a role in the cognitive dysfunction of Down syndrom. Life-long exposure to increased amyloid and myo-inositol levels in the brain are thought to lead to synaptic dysfunction and cognitive disability. ELND005 may have the potential to improve cognition in Down syndrom by decreasing amyloid levels and regulating myo-inositol-dependent neuronal signalling.
Disease: Down Syndrome
Therapeutic area: Genetic diseases
Country: USA
Trial
details: Study ELND005-DS201 will evaluate the safety and pharmacokinetics of 2 doses of ELND005 and placebo in young adults with Down syndrome without dementia, and will also include select cognitive and behavioural measures. (NCT01791725)
Latest
news: * On September 3, 2013, Elan has announced the first patient dosing in a Phase 2a study of ELND005 in Down syndrome.The first person was dosed at the site of Dr. Ira Lott, Professor of Neurology and Pediatrics and Down syndrome expert at the University of California, Irvine.
