Amgen and Novartis Expand Collaboration to Prevent Alzheimer’s

Banner Alzheimer’s Institute’s pioneering candidate CNP520 headed for new study.

Part of the Banner Alzheimer’s Institute’s Generation Program, Amgen and Novartis announced their expanded support in developing CNP520, Banner’s investigational drug that has demonstrated its potential in preventing or delaying the progression of Alzheimer’s disease.

The Amgen/Novartis collaboration will help Banner initiate a new trial titled Alzheimer's Prevention Initiative (API) Generation Study 2. According to the companies, the trial follows the launch of the Generation Study and will determine whether or not the BACE1 inhibitor CNP520 can delay or prevent the onset of Alzheimer’s disease symptoms in high-risk populations.

Sean E. Harper, Amgen’s Executive VP of Research and Development explained that: "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." Through a unique combination of genetic testing and counseling in cognitively healthy adults, said Harper, “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."

According to the announcement, BACE1 is an enzyme that plays a significant role in producing Amyloid β, a protein that accumulates in the brains of Alzheimer's patients years before clinical symptoms present themselves.

U.S. participants in the Generation Study 2 began enrollment in trials in August 2017. The study will eventually include more than 180 sites in over 20 countries around the world. This five-year study intends to recruit about 2,000 cognitively healthy participants, ages 60 to 75 at high risk of developing the disease. This risk is based on the patient’s age and if they carry either two copies of the apolipoprotein E (APOE) 4 gene or one copy of the gene, with evidence of elevated brain amyloid.

"This expanded collaboration builds upon the API Generation Study 1 … and is another step in our effort to take clinical trials to a critical new stage," said Pierre N. Tariot, Co-director of API and Director of BAI, a division of Banner Health, one of the largest nonprofit healthcare systems in the U.S. "This approach continues to shift the Alzheimer's research paradigm from reversing disease damage to attacking its root cause before symptoms surface,” said Tariot. “It is our hope that by conducting research targeting the disease at earlier stages, we will have a better chance of delaying or preventing the onset of the disease."

 

Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.

Q: