SCIENCE & technologies
With unique pharmacological properties, ELND005 has the potential to be an oral drug that can address both neuropsychiatric changes and cognitive declines associated with Alzheimer's disease
ELND005 is a small molecule oral compound that uniquely provides a dual mechanism of action to address changes in cognition, function and neuropsychiatric outcomes in Alzheimer's disease (AD). A Phase II study in AD patients provides the key data supporting the use of ELND005 in AD. The study showed (i) encouraging trends of efficacy on cognitive and functional endpoints in a pre-specified sub-analysis of mild AD patients and (ii) a significant reduction in the emergence of new neuropsychiatric symptoms (NPS) including agitation and aggression in mild-to-moderate AD patients.
Dual Mechanism of Action of ELND005
ELND005’s dual approach to AD also aligns with its effect on two distinct mechanisms of action. The Phase II AD study demonstrated ELND005 treatment was associated with a reduction in the levels of beta amyloid and tau proteins in the cerebrospinal fluid, illustrating target engagement (beta amyloid pathology) as well as neuronal protection (tau). In addition, ELND005 led to reduction in myo-inositol levels in the brain, an effect that is shared by other approved neuropsychiatric drugs such as lithium and valproic acid.
Key Findings from ELND005 Phase II Study in Mild-to-Moderate AD Patients
• Reduction in cognitive and functional decline in mild AD population
• Reduction in emergence of new neuropsychiatric symptoms (including depression, anxiety)
• Evidence of target engagement (CSF) and neuronal protection
• Acceptable safety and tolerability profile in humans
• Oral drug that crosses the blood-brain-barrier
• Supports Phase III development in AD
Clinical Development
Agitation and Aggression in AD
• Phase II clinical study in moderate-to-severe AD patients initiated (Nov 2012) - Link to press release
Cognition and function in AD
• Phase II clinical study in mild-to-moderate AD patients completed (Aug 2010) - Link to press release
ELND005 is a small molecule oral compound that uniquely provides a dual mechanism of action to address changes in cognition, function and neuropsychiatric outcomes in Alzheimer's disease (AD). A Phase II study in AD patients provides the key data supporting the use of ELND005 in AD. The study showed (i) encouraging trends of efficacy on cognitive and functional endpoints in a pre-specified sub-analysis of mild AD patients and (ii) a significant reduction in the emergence of new neuropsychiatric symptoms (NPS) including agitation and aggression in mild-to-moderate AD patients.
Dual Mechanism of Action of ELND005
ELND005’s dual approach to AD also aligns with its effect on two distinct mechanisms of action. The Phase II AD study demonstrated ELND005 treatment was associated with a reduction in the levels of beta amyloid and tau proteins in the cerebrospinal fluid, illustrating target engagement (beta amyloid pathology) as well as neuronal protection (tau). In addition, ELND005 led to reduction in myo-inositol levels in the brain, an effect that is shared by other approved neuropsychiatric drugs such as lithium and valproic acid.
Key Findings from ELND005 Phase II Study in Mild-to-Moderate AD Patients
• Reduction in cognitive and functional decline in mild AD population
• Reduction in emergence of new neuropsychiatric symptoms (including depression, anxiety)
• Evidence of target engagement (CSF) and neuronal protection
• Acceptable safety and tolerability profile in humans
• Oral drug that crosses the blood-brain-barrier
• Supports Phase III development in AD
Clinical Development
Agitation and Aggression in AD
• Phase II clinical study in moderate-to-severe AD patients initiated (Nov 2012) - Link to press release
Cognition and function in AD
• Phase II clinical study in mild-to-moderate AD patients completed (Aug 2010) - Link to press release