Parties to collaborate on a new Generation Study 2, assessing whether investigational drug CNP520 can prevent or delay the symptoms of Alzheimer's disease (AD)
Clinical trial is part of the Generation Program, which includes cognitively healthy people at genetic risk of developing AD
Generation Study 2 aims to include a broader high-risk population, as compared to the ongoing Generation Study 1
44 million people globally are estimated to have AD or a related dementia, with one new case diagnosed every three seconds,
Basel, November 2, 2017- Novartis, Amgen and the Banner Alzheimer's Institute (BAI) today announced an expanded collaboration to initiate a new trial - the Alzheimer's Prevention Initiative (API) Generation Study 2. This trial follows the launch of the Generation Study 1, and will determine whether the BACE1 inhibitor CNP520 can prevent or delay the onset of Alzheimer's disease symptoms in a high-risk population. BACE1 is an enzyme that plays an important role in the production of Amyloid ß, a protein which accumulates in the brains of individuals with AD years before clinical symptoms begin. More information on the sites participating in Generation Study 2 can be found at Clinical trials.gov and in the website www.GenerationProgram.com.
"Expanding our collaboration with Banner Alzheimer's Institute stands testament to our belief that preventing amyloid buildup is one of the most promising approaches to treating Alzheimer's disease," said Vas Narasimhan, M.D., Global Head Drug Development and Chief Medical Officer for Novartis. "If we determine that our BACE1 inhibitor can prevent or delay the onset of symptoms in healthy yet high-risk populations, this would represent a tremendous breakthrough for those that may face this debilitating disease."
The Generation Study 2 started enrolling participants in the US in August 2017, and will eventually include more than 180 sites in more than 20 countries around the world. This five-year study will recruit approximately 2,000 cognitively healthy participants, aged 60 to 75, who are at high risk of developing AD based on their age and who carry either two copies of the apolipoprotein E (APOE) 4 gene or one copy of the gene with evidence of elevated brain amyloid. This is different from the Generation Study 1, which only targeted those who carry two copies of the APOE4 gene. APOE4 is the major genetic risk factor for late-onset Alzheimer's disease. Roughly one in four people carry a single copy of the APOE4 gene, but only about two percent of the world's population carries two copies. Eligible participants will be randomized to receive placebo or one of two doses of CNP520 (15 mg or 50 mg), co-developed by Novartis and the biotechnology company Amgen.
"This expanded collaboration builds upon the API Generation Study 1 which launched last year, and is another step in our effort to take clinical trials to a critical new stage," said Pierre N. Tariot, MD, 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. It is our hope that by targeting people earlier, we will have a better chance of delaying or preventing the onset of the disease."
Participants will be recruited via multiple venues, including, in the US, the Alzheimer's Prevention Registry's GeneMatch program (www.endALZnow.org/GeneMatch). GeneMatch is a first-of-its-kind program designed to identify a large group of people interested in volunteering for Alzheimer's disease prevention research studies, based in part on their APOE genetic information.
About the Generation Program The Generation Program consists of two pivotal Phase 2/3 studies. The studies are testing whether investigational anti-amyloid treatments might prevent or delay the emergence of symptoms of AD in people at particularly high risk for developing the disease at older ages because of their genetic status.
The Generation Study 2 is examining whether the BACE1 inhibitor CNP520 can prevent or delay the onset of the symptoms of the disease in individuals who are at high risk of developing AD because of their age and because they carry either one or two copies of the APOE4 gene. Those with one copy will require evidence of elevated brain amyloid.
About Alzheimer's Prevention Initiative The Alzheimer's Prevention Initiative (API) is an international collaborative research effort formed to launch a new era of Alzheimer's prevention research. Led by the Banner Alzheimer's Institute, the API conducts prevention trials in cognitively healthy people at increased genetic risk for Alzheimer's disease. It will continue to establish the brain imaging, biological and cognitive measurements needed to rapidly test promising prevention therapies and provide registries to support enrollment in future prevention trials. API is intended to provide the scientific means, accelerated approval pathway with the cooperation of the regulatory agencies and enrollment resources needed to evaluate the range of promising Alzheimer's prevention therapies and find ones that work. For more information, go to www.banneralz.org.
Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals for CNP520 or the other investigational products described in this press release, or regarding potential future revenues from such products or the collaboration with Amgen and Banner Alzheimer's Institute. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that CNP520 or the other investigational products described in this press release will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that the collaboration with Amgen and Banner Alzheimer's Institute will achieve any or all of its intended goals and objectives, or be commercially successful. Nor can there be any guarantee that CNP520 or the other investigational products described in this press release will be commercially successful in the future. In particular, our expectations regarding such products, and the collaboration with Amgen and Banner Alzheimer's Institute, could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
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References 1. Alzheimer's Association 2015. Changing the Trajectory of Alzheimer's Disease: How a Treatment by 2025 Saves Lives and Dollars 2. Policy Brief for Heads of Government: The Global Impact of Dementia 2013-205. Published by Alzheimer's Disease International (ADI), London. December 2013. 3. Genin et al 2011; Liu at al 2013; Jansen et al 2015