Elan achieves patient enrolment target in Alzheimer’s study

Elan has announced it and Transition Therapeutics have achieved the patient enrolment target for a phase II clinical study of ELND005 (AZD-103) in individuals suffering from Alzheimer’s disease.

The company explains the trial is a randomised, double-blind, dose-ranging, placebo-controlled, safety and efficacy study in participants with mild to moderate Alzhemier’s.

Each of the planned treatment periods are roughly 18 months, Elan explains.

The neuroscience-based biotechnology company notes ELND005 is an orally administered therapeutic agent, which has been granted fast track designation from the US Food and Drug Administration (FDA) for treatment of mild to moderate Alzheimer’s.

Continuing, it explains fast track designation “facilitates development and may expedite regulatory review of drugs that the FDA recognises as potentially addressing an unmet medical need for serious or life-threatening conditions”.

In recent weeks, Elan and Biogen announced that a post-hoc analysis showed Tysabri (natalizumab) treatment increases the chance of achieving sustained improvement in physical disability over two years in comparison to a placebo.

Commenting on the findings, Dr Frederick E Muschauer, Smith professor and chair of the department of Neurology at the State University of New York at Buffalo, said: “This analysis represents the first evidence supporting a sustained improvement in function associated with an approved disease modifying therapy.”