A phase II study of Lundbeck's candidate Alzheimer's treatment Lu AE58054 has found that it improves cognition when added to a standard drug for the disease, and the company now intends to press ahead with a pivotal trials programme.
Lu AE58054 is a selective serotonin 5HT6 receptor antagonist, with a different mechanism of action than currently available Alzheimer's medications such as Pfizer/Eisai's Aricept (donepezil), Novartis' Exelon (rivastigmine) and Shire's Reminyl (galantamine), which work by inhibiting the action of cholinesterases.
Current Alzheimer's drugs are acknowledged to have useful but limited benefits in treating patients with the disease, so any drug that could improve their efficacy could have a significant impact.
The phase II trial of Lu AE58054 in 278 patients with mild-to-moderate Alzheimer's disease looked at the effects of adding the drug to treatment with a standard dose of donepezil. It found a statistically significant improvement in cognition over 24 weeks when compared to donepezil plus placebo.
Secondary endpoints, including measures of global status and activities of daily living also showed positive trends with the addition of Lu AE58054.
Investigational drugs to treat Alzheimer's must generally show an impact on both cognition and activities of daily living to meet the requirements for regulatory approval.
Lu AE58054 was also well-tolerated in combination with donepezil at the selected dose, said Lundbeck, which will present the data in full later this year at upcoming medical congresses.
The company said Alzheimer's disease affects over 26m people worldwide, with a cost to society estimated at $600bn per year. Lu AE58054 is also being developed to treat cognitive impairments associated with schizophrenia.
Other 5-HT6 receptor antagonists in development as cognition enhancers include GlaxoSmithKline's SB-74257 (phase II), Abbott's ABT-354 (phase II), Pfizer's PF-5212377 (phase II) and Roche/BioTie's SYN-120 (phase I ).