- Johnson & Johnson (JNJ +0.4%) unit Janssen has decided to terminate its Phase 2b/3 clinical trial, EARLY, and a Phase 2 long-term safety study evaluating BACE inhibitor atabecestat for slowing the rate of cognitive decline in patients with preclinical Alzheimer's disease (AD). The company took action after observing serious elevations in liver enzymes in certain treated patients that undermined the drug's benefit-risk profile.
- Janssen's decision is another setback for BACE (beta-secretase) inhibition as a treatment approach for patients at risk of developing AD. BACE is an enzyme that plays a key role in the formation of amyloid plaques in the brain, characteristic in AD sufferers.
- Several months ago, Merck pulled the plug on its BACE candidate verubecestat after determining its late-stage study would likely fail. Vitae Pharmaceuticals (AGN -0.6%) and collaboration partner Boehringer Ingelheim terminated their efforts on BI 1181181 three years ago due to side effects.
- Other companies are staying the course with their BACE programs, however. Amgen (AMGN +1.1%) and collaboration partner Novartis (NVS +0.1%) are investigating CNP520, Eli Lilly (LLY +0.7%) and AstraZeneca (AZN -0.3%) are co-developing AZD3293 and Eisai (OTCPK:ESALF +8.5%) and Biogen (BIIB +0.3%) are co-developing E2609.
- Previously: Merck bails on Alzheimer's candidate verubecestat (Feb. 13)
- Previously: Vitae Pharma up on move to new Alzheimer's candidate (April 6, 2015)