Amgen, Novartis Rev Up for New Alzheimer's Study
The trial is called the Alzheimer’s Prevention Initiatives (API) Generation Study 2, which will follow the launch of the Generation Study 1. It will evaluate whether CNP520, a BACE1 inhibitor, can prevent or delay onset of Alzheimer’s disease symptoms in a high-risk population.
The Generation Study 2 began enrolling patients in the U.S. in August. It is planned to include more than 180 locations in more than 20 countries. The study will last five years and include approximately 2,000 cognitively health participants. Their ages are 60-75 and based on genetic tests, carry either two copies of the apolipoprotein E (APOE) 4 gene or one copy of the gene with evidence of increased brain amyloid.
The Generation Study 1 only targets people with two copies of APOE4. APOE4 is a major genetic risk factor for late-onset Alzheimer’s disease. About 25 percent of people carry a single copy of the APOE4 gene, but only around two percent of the population worldwide carries two copies.
Participants in the studies will receive either a placebo or one of two doses of CNP520. The drug was co-developed by Amgen and Novartis.
“As a leader in the challenging fight to unlock the biology of serious illnesses like Alzheimer’s disease, we are pleased to support the launch of the Generation Study 2 with our partners at Novartis and Banner Alzheimer’s Institute to further explore promising potential therapeutic options for this highly debilitating disease,” said Sean Harper, Amgen’s executive vice president of Research and Development, in a statement. “Through the unique combination of genetic testing and counseling in cognitively healthy adults, the Generation Study 2 exhibits an innovative clinical approach that may offer insight towards Alzheimer’s prevention for those at highest risk for developing the disease.”
One of the key theories behind Alzheimer’s disease is the accumulation of amyloid-beta plaques in the brain. BACE1 is an enzyme that has a role in the production of amyloid-beta.
The Alzheimer’s Prevention Initiative (API) is an international collaborative research program led by the Banner Alzheimer’s Institute. It conducts trials in cognitively healthy people at high-risk of Alzheimer’s with a focus on prevention. Part of the initiative is the establishment of brain imaging, biological and cognitive measurements to test promising prevention treatments and to assist registries in enrollment for future prevention trials.
The two companies, Amgen and Novartis, launched their Neuroscience Collaboration in 2016, with the intention to develop and commercialize therapies in the field of migraine and Alzheimer’s disease. In migraine, that includes Amgen’s Aimovig (erenumab), whose Biologics License Application was accepted by the U.S. Food and Drug Administration (FDA) in July 2017, and AMG 301, which is currently in Phase I trials.
In April 2017, the collaboration expanded to include co-commercialization of Aimovig in the U.S. Amgen retains exclusive rights to commercialize drugs other than Aimovig in the migraine program in the U.S. and Japan, and Novartis has exclusive commercialization rights in Europe, Canada and the rest of the world. The two companies are also collaborating on a BACE inhibitor program in Alzheimer’s disease.