Lundbeck Canada, a subsidiary of H Lundbeck, has reported that Lu AE58054 met its primary cognition endpoint in a Phase 2, proof-of-concept study of Alzheimer’s disease.
The investigational Alzheimer’s drug, Lu AE58054, is a potent and selective 5-HT6 receptor antagonist.
Lundbeck Canada scientific affairs senior director, Jean Proulx, said: "We see Lu AE58054 as having a strong potential in Alzheimer’s disease, a disease with a huge unmet medical need."
The study was conducted in 278 patients in Canada, Europe and Australia, with either Lu AE58054 (plus 10mg a day donepezil) or placebo (plus 10mg a day donepezil).
Patients receiving the investigational compound achieved statistically significant improvement in cognition, as measured by the Alzheimer’s Disease Assessment Scale-cognitive sub-scale (ADAS-cog) over a 24-week treatment period versus donepezil monotherapy (10mg a day).
Measures of global status and activities of daily living, which were the secondary endpoints of the trial, also showed positive trends with the addition of Lu AE58054, compared with patients who received donepezil alone.
Treatment with augmentation therapy Lu AE58054 was well tolerated in the study, according to the company.
Toronto Memory Program medical director and behavioural neurologist, Sharon Cohen, said that as the Canadian population ages, effective and safe treatments that can help reduce Alzheimer’s symptoms are becoming increasingly crucial.
"It is encouraging to see these positive preliminary results and it will be interesting to follow this compound’s development," Cohen added.
Lundbeck intends to initiate a major pivotal clinical programme of Lu AE58054, potentially including development and commercial partnerships.