On 31 December, the company Axsome Therapeutics, which develops therapies for the management of central nervous system disorders, announced that it has started a Phase III clinical trial with its drug candidate AXS-05 for the treatment of Alzheimer’s disease (AD) agitation. The ACCORD Phase III trial is a randomised, double-blind and placebo-controlled trial to evaluate the efficacy and safety of AXS-05 in the treatment of AD agitation. Topline results from the ACCORD trial are expected in mid-2022.
AXS-05 received the Breakthrough Therapy designation from the US Food and Drug Administration (FDA) in August 2020. A Breakthrough therapy designation is a process to expedite the development and review of drugs for serious or life-threatening conditions. The Breakthrough therapy designation for AXS-05 in AD agitation was supported by positive results from the pivotal ADVANCE-1 Phase II/III study, which enrolled 366 US participants with agitation associated with AD. This trial met its primary endpoint by demonstrating a statistically significant improvement in AD agitation.
