Clinical Trials

Eisai and Biogen have announced that Eisai has shared new data for Leqembi (lecanemab-irmb) 100mg/mL injection for intravenous (IV) use at the 16th Annual Clinical Trials on Alzheimer’s Disease (C TA D) conference in Boston, US on 24-27 October 2023.

The data presented includes information on subcutaneous (SC) formulation including the safety and effects on brain amyloid. For example, it was demonstrated that week ly SC administration led to a 14% greater amyloid plaque removal than biweek ly IV administration, SC pharmacokinetics were higher than IV by 11% and there were lower systemic injection reaction rates with SC compared to IV.

The data also included latest data from Tay Pet Longitudinal sub-study, in which 76% of patients showed no decline and 60% showed clinical improvement at 18 months in earlier stage early AD populations. In addition, efficacy results from the Leqembi Clarity AD open-label extension study were shared, demonstrating that patients continued to show benef it after 24 months of treatment.

Finally, the mechanism-based rationale of Leqembi treatment for early AD was shared, showing that dual-acting Leqembi continued to support brain neuron function through the remova l of highly toxic proteins (protof ibrils), which can cause neuronal injury and death even after plaque remova l, providing patients with potential continued benef it.

The company intends to submit a Leqembi SC formulation Biologics License Application (BLA) to the US Food and Drug Administration (FDA) by 31 March 2024.

The company’s press release ‘discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approva l.’