Date: 2013-07-17
Type of information: Initiation of preclinical development
phase: 2
Announcement: enrollment 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 recently published Phase 2 study ELND005-AD201 in AD. ELND005 is also being studied as a maintenance treatment of Bipolar Disease in an ongoing study (Study ELND005-BPD201).
Disease: agitation/aggression in patients with moderate to severe Alzheimer’s disease
Therapeutic area: Neurodegenerative diseases
Country: USA, Canada, other undisclosed and selected regions
Trial
details: The objectives of Study AG201 are to evaluate the efficacy, safety and tolerability of ELND005 over 12 weeks of treatment in patients with moderate to severe AD, who are experiencing at least moderate levels of agitation/aggression. The study is expected to enroll approximately 400 patients at multiple sites in the US, Canada and other selected regions. In the Phase 2 AD Study (AD201), ELND005 appeared to decrease the emergence and severity of specific NPS, an effect which seemed to correlate with drug exposure for some symptoms. ELND005 also led to a sustained reduction of brain Myo-inositol levels that are thought to play a role in phospho-inositol signaling pathways and synaptic activity. (NCT01735630)
Latest
news: * On July 17, 2013, Elan Corporation has announced that the FDA has granted Fast Track Designation to its development program for ELND005 which was submitted for the treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer’s disease (AD). The FDA concluded that the development program for ELND005 for the treatment of NPS in AD meets their criteria for Fast Track Designation.Elan’s ongoing ELND005 clinical program includes the Phase 2 Study AG201 in patients with AD, who are experiencing at least moderate levels of agitation/aggression and the safety extension Study AG251.* On November 27, 2012, Elan Corporation has announced that it has enrolled the first patient in a Phase 2 clinical trial of ELND005 (Study AG201) for the treatment of agitation/aggression in patients with moderate to severe Alzheimer’s disease (AD). “Agitation/Aggression are common and distressing neuropsychiatric symptoms (NPS) of AD. These symptoms are a leading cause of patients being placed in nursing homes,” said Dr. Bruno Vellas, MD PhD, Chairman of Internal and Geriatric Medicine at University Hospital Toulouse, France and Principal Investigator of the European Alzheimer’s Disease Consortium. “Approximately 90% of AD patients develop NPS, and up to 60% develop agitation/aggression over the course of their disease. With no approved therapies for agitation/aggression in most countries, including the US, it is a major treatment problem in AD. This trial is an important step in providing a potential therapy to help manage these symptoms.”
