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H. Lundbeck A/S (Lundbeck) today announced that Lu AE58054 has met its primary endpoint in a fixed dose, randomised, placebo-controlled clinical study in 278 patients suffering from Alzheimer’s disease.
The investigational compound, Lu AE58054 is a novel, selective 5HT6 receptor antagonist with a different mechanism of action than currently available Alzheimer’s medications.
Augmentation therapy with Lu AE58054 (plus 10 mg/day donepezil) at the selected dose resulted in statistically significant improvement in cognition, as measured by the ADAS-cog (Alzheimer’s Disease Assessment Scale-cognitive sub-scale) over a 24-week treatment period versus placebo (plus 10 mg/day donepezil).
Secondary endpoints, including measures of global status and activities of daily living also showed positive trends with the addition of Lu AE58054, compared with patients who only received donepezil.
Treatment with Lu AE58054 in this study was well tolerated.
“These results are very encouraging, and we are now evaluating how to best proceed with the development of Lu AE58054,” says Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck, and continues: “We believe that there is a strong need for better treatments for patients with Alzheimer’s disease, and Lundbeck sees Lu AE58054 as a potential new treatment option for this devastating disease.“
The study was conducted in 278 patients suffering from moderate Alzheimer’s disease, and Lu AE58054 was administered as add-on to donepezil, a commonly used acetylcholinesterase inhibitor for a period of 24 weeks.
In the study, Lu AE58054 as adjunctive treatment to donepezil was compared with placebo plus donepezil. Lu AE58054 (plus donepezil) demonstrated significant improvements in cognitive function in Alzheimer’s disease compared to placebo (plus donepezil), as assessed by ADAS-cog. Lu AE58054 was considered overall to be well tolerated at the selected dose.
The study was conducted in selected European countries as well as Canada and Australia.
Lundbeck is now evaluating the future development strategy of Lu AE58054 with the intention to initiate a major pivotal clinical programme potentially including development and commercial partnerships.
Full data from this study will be made available through scientific disclosure at upcoming medical congresses and in scientific publications.