Ivan Cheung,
chairman and CEO of Eisai Inc.
When speaking to people living with Alzheimer’s disease and their loved ones, the first thing I tell them is that I am sorry it has taken so long to make the progress that has been so desperately needed. When Eisai began this research, no one would have imagined it would test our dedication for as long as it has. Each person I meet who is living with this disease strengthens my perseverance to solve the puzzle of Alzheimer’s disease, because even with the progress that has been made, much remains to be done.
As the seventh leading cause of death for adults, Alzheimer’s disease represents a growing health challenge that has an enormous impact on patients, family members, health care systems and society at large.1 In 2021, over 11 million Americans provided more than 16 billion hours of unpaid care for people with Alzheimer’s disease or other dementias, and the direct cost of care to the nation was approximately $321 billion.1 As individuals and a society, we are in need of new solutions to change the course of this devastating disease.
At Eisai, that need is our inspiration. For four decades, we have led the way in Alzheimer’s disease research and development. These efforts resulted in one of the first drugs approved by the Food and Drug Administration to treat dementia due to Alzheimer’s disease more than 25 years ago. But we did not stop there. We continued to explore the potential role of medication across all stages of the disease, from asymptomatic stages to moderate and severe stages.
Our in-house research teams follow the “knowledge creation” method of scientific development as we seek to address the underlying mechanisms of Alzheimer’s disease and other neurologic conditions. Through a collaborative and iterative process, we bring together individual knowledge, and build upon and combine it with the contributions of others for over four decades. In this process, knowledge is continuously created and expanded as the participants collaborate, interact and learn.2
Knowledge creation played an essential role in the research that led to the development of our therapies to date. It is the process we follow and the culmination of four decades of stubborn perseverance that we believe will help us to combat the devastating impact of the disease on memory function in people living with Alzheimer’s disease.
There were, however, other drug candidates Eisai pursued along our journey to slow the course of Alzheimer’s disease by targeting the amyloid pathway. While our early studies using amyloid-beta production inhibitors such as gamma-secretase modulators and beta-secretase inhibitors were eventually discontinued, we applied the lessons learned and insights gained from that research to identify more specific types of amyloid-beta with the goal of achieving significant clinical improvements. Additionally, samples from research done with beta-secretase inhibitors are still being used to identify biomarkers and develop algorithms to predict patient outcomes in Alzheimer’s disease.
This research also expanded our knowledge of disease progression and disease staging. As a result, we implemented innovative biomarkers to better correlate with amyloid plaque in the brain and to define the combination of amyloid, tau (a protein that’s vital to better health) and neurodegeneration (disease in which cells of the central nervous system stop working or die) known as the ATN pathway.
Scientist at the Eisai Center for Genetics Guided Dementia Discovery (G2D2) in Cambridge, Mass.
Eisai is continuing to advance care in Alzheimer’s disease via this multi-dimensional, yet targeted path to our ultimate goal: prevention and stopping progression. We are driven by our human health care mission, which aims to advance the understanding of brain health and bring forward innovative disease-modifying solutions that can help prevent and stop progression of Alzheimer’s disease. This mission empowers us to push past the boundaries of science to deliver life-changing therapies while maintaining focus on one core principle: Patients and their families come first, and we have a responsibility to listen to and learn from them. For example, we learned a great deal running the Clarity AD study, a global confirmatory Phase III placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer’s disease. It helped us to better understand the burden of patients and caregivers, which steered us toward implementation of home infusion, and the development of a subcutaneous formulation, decentralized clinical trials and digital technologies.
Our relentless perseverance and a commitment to providing meaningful and timely answers to patients and the clinical community led us to develop a novel and highly complex clinical study using an unprecedented approach in Alzheimer’s disease for the evaluation of an anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment. The Phase II study’s adaptive design (known as Bayesian design), based on an algorithm derived from thousands of computer simulations, tested multiple doses and was large (856 patients treated) and long enough (18 months) to inform a robust Phase III study. The Bayesian design helped us identify the right dose regimen, patient selection criteria and endpoints that would ultimately validate the pursuit of the amyloid pathway.
Collaboration-based research is a key element of our approach to accelerating drug discovery and development. We are proud to work with patient, medical, academic, scientific and civic organizations to address challenges patients and their families face—with an emphasis not simply on therapies, but on solutions.
Eisai and University College London (UCL) formed a strategic alliance to facilitate several early- stage projects to identify and validate novel drug targets across key processes in neurodegeneration.3 Eisai’s drug discovery and development capabilities, coupled with UCL’s world-class research in neurodegenerative diseases and expertise in clinical translation, led to a clinical trial for a new drug candidate to target tau protein for Alzheimer’s disease.3
Collaboration also plays an instrumental role in our ongoing clinical research to fully explore the potential role of compounds in advanced stages of development for Alzheimer’s disease and related neurological conditions. The AHEAD 3-45 study, designed to test whether an investigational treatment can slow or stop the earliest brain changes due to Alzheimer’s disease in people with a higher risk of developing the disease later in life, is a collaborative effort among Eisai, the National Institutes of Health and the Alzheimer’s Clinical Trial Consortium, a network of leading academic Alzheimer’s disease research centers.4
Lab at Eisai’s Center for Genetics Guided Dementia Discovery (G2D2) in Cambridge, Mass.
Eisai also has a comprehensive research agreement with Washington University School of Medicine in St. Louis to create potential novel treatments for neurodegenerative disorders. The Phase II/III Tau NexGen Study conducted by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN- TU), led by Washington University’s School of Medicine, is exploring the safety, tolerability, biomarkers and cognitive efficacy of Eisai’s anti-MTBR (microtubule binding region) tau antibody for the treatment of dominantly inherited Alzheimer’s disease.5 Additionally, our anti-amyloid-beta protofibril antibody was selected as the background agent for this study.
The beauty of perseverance is that when well-applied, it enables one to address formidable challenges. Eisai is uniquely focused on neurology and oncology, and the path to progress in these areas is neither straightforward nor quick, requiring an unwavering focus and longstanding commitment—often in the face of challenges. We bring the same unstoppable spirit to all of our work as we seek to deliver transformative therapies to those who need them, as fast as we can.
Click here to learn more about Eisai’s approach to Alzheimer’s disease and other neurological conditions.
Sources:
1. 2022 Alzheimer’s Disease Facts and Figures
2. Managing Knowledge in Organizations: A Nonaka’s SECI Model Operationalization
3. Joint Strategic Alliance on Neuroscience Research
4. The AHEAD Study
5. Japanese firm Eisai partners with Washington University for treatment of neuro diseases
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This article was created and originally published by WP Creative Group. Here is the original article link: https://www.washingtonpost.com/creativegroup/eisai/the-power-of-perseverance-in-tackling-alzheimers-disease/ to learn more about Eisai’s approach to Alzheimer’s disease and other neurological conditions.