11/30/2012Statement on Avagacestat Development Status
Bristol-Myers Squibb recently assessed data on avagacestat from a completed Phase 2 study in mild-to-moderate Alzheimer's disease and an ongoing Phase 2 study in predementia Alzheimer’s disease. The evaluation did not establish a profile that supported advancement to Phase 3 development. In light of this finding, Bristol-Myers Squibb has decided to terminate the avagacestat clinical development program. Dosing in the ongoing Phase 2 study in predementia Alzheimer’s disease (CN156-018) will be discontinued as soon as operationally feasible.
Data from a November 2012 interim analysis of the Phase 2 predementia study were weighed in the decision to discontinue development of avagacestat. No new safety issues emerged in this interim analysis; however, the efficacy observed did not justify further development when evaluated in the context of all avagacestat data. The Company plans to share data from this study at an appropriate scientific forum next year.
Amyloid remains an important target for Alzheimer’s research and Bristol-Myers Squibb continues to test the amyloid hypothesis with an investigational gamma secretase modulator in Phase 1 development. Bristol-Myers Squibb is committed to helping address the significant unmet need for effective treatments for Alzheimer’s patients, using a data-driven approach to the development of our investigational compounds.