Lundbeck’s Alzheimer’s drug shows promise
pharmafile | May 29, 2012 | News story | Research and Development, Sales and Marketing | Alzheimer's, Lundbeck
Lundbeck’s Alzheimer’s candidate Lu AE58054 has shown signs in a phase II study of helping patients’ mental activity.
Sufferers receiving it in combination with Pfizer and Eisai’s Alzheimer’s drug Aricept (donepezil) achieved statistically significant improvement in cognitive performance, thus meeting the study’s primary endpoint.
Lu AE58054 is a novel, selective 5-HT6 receptor antagonist targeting a receptor primarily found in areas of the brain involved in cognition.
The manufacturer used Lu AE58054 as augmentation therapy in a 24-week study in 278 patients in Europe, Canada and Australia who were suffering from the moderate form of the disease.
Those receiving Lu AE58054 plus acetylcholinesterase inhibitor Aricept demonstrated better cognitive function – measured by the ADAS-cog (Alzheimer’s Disease Assessment Scale-cognitive sub-scale) – compared to those on placebo plus Aricept.
“These results are very encouraging, and we are now evaluating how to best proceed with the development of Lu AE58054,” says Anders Gersel Pedersen, Lundbeck’s head of R&D.
The company says it wants to “initiate a major pivotal clinical programme potentially including development and commercial partnerships”.
Lundbeck started its proof of concept study in December 2009 after early trials suggested that a 5-HT6-receptor antagonist could offer potential benefits.
Secondary endpoints, such as measures of activities of daily living also showed what Lunbeck called “positive trends” in patients receiving Lu AE58054.
Full data from the study will be made available at future medical congresses and in scientific publications.
Alzheimer’s disease could certainly be a highly fruitful area for pharma companies since it currently affects over 26 million people worldwide.
That figure will rise as ageing populations – particularly in more developed nations – become the norm: the progressive brain disorder typically occurs in people aged 65 and over.
Speaking in February at a parliamentary event on innovation, ABPI chief executive Stephen Whitehead warned of a “social care implosion” unless a cure for Alzheimer’s is found and many firms are trying to do just that.
Targacept and AstraZeneca have a couple of products in phase II, and eagerly awaited phase III results from two Alzheimer’s candidates – Eli Lilly’s solanezumab and Pfizer’s bapineuzumab – are expected later this year.
Adam Hill
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