Eli Lilly confirmed in a press release today that it will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer’s disease.
The drug failed to meet the primary endpoint in the EXPEDITION3 clinical trial, a phase III study led by the company. Patients treated with the drug did not show a statistically significant slowing in cognitive decline compared to patients treated with a placebo.
Therefore, the company plans to “work with investigators to appropriately conclude the open-label extensions for EXPEDITION, EXPEDITION2 and EXPEDITION3”. No decision has been made yet regarding other studies.
The company will present part of the results associated with this study at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting on Thursday, December 8th.
Solanezumab was the frontrunner of 3 treatments targeting the beta-amyloid protein. As a monoclonal antibody, it was aimed to bring amyloid beta to destruction through the immune system.
The strategy is similar, but not identical to Biogen’s aducanumab. While this drug is also a monoclonal antibody targeting amyloid beta, its action mechanism is different.