Eisai Continues Alzheimer's Research, Adds 2 Alzheimer's Pros as Execs

The industry was shaken up when Tokyo-based Eisai and its collaboration partner, Biogen, announced they were abandoning huge swaths of their Alzheimer’s program related to aducanumab in late March.

Eisai, however, continues its efforts in the disease. Just about a week before the announcement, Eisai announced the launch of a global Phase III trial of BAN2401, an anti-amyloid beta protofibril antibody, in Alzheimer’s patients. It’s being jointly developed with Biogen. The Clarity AD/Study 301 will look at 1,566 patients with mild cognitive impairment (MCI) caused by Alzheimer’s with confirmed amyloid brain pathology.

And two weeks later, Eisai announced that a Data Safety Monitoring Board (DSMB) had recommended continuing the Phase III MISSION AD clinical trials of an oral beta amyloid cleaving enzyme (BACE) inhibitor, elenbecestat, in early Alzheimer’s, after a review of the safety data. MISSION AD is made up of two global Phase III clinical trials with the same protocols, MISSION AD1 and MISSION AD2. Patients in the trials are randomly selected to receive either 50 mg of elenbecestat or placebo daily for 2 years. The primary endpoint utilizes the Clinical Dementia Rating Sum of Boxes.

Now Eisai has announced the appointments of two neuroscience experts to its executive suite. Harald Hampel joins Eisai as vice president, Global Medical Affairs. Michael Irizarry will join as vice president, Clinical Research. Both will focus on the company’s Alzheimer’s and dementia pipeline.

Hampel will create and oversee the company’s global AD/dementia medical strategies and oversee clinical trials, Phase IIIb/IV projects, and Eisai’s medical education and medical information programs. Hampel is the founding director of the Alzheimer Memorial Center at the University of Munich. He was most recently full Professor and Excellence Chair, Scientific Director at the Institute for Memory and Alzheimer’s Disease, European Center of Excellence in Neurodegenerative Disease at Sorbonne University in Paris.

Hampel earned his MD and Ph.D. from the University of Munich. He also holds an M.A. in Hospital Administration from the University of Cologne and an M.A. from Trinity College, University of Dublin.

“I am delighted to join the outstanding global Eisai effort to discover and develop innovative therapies for Alzheimer’s disease, with the ultimate goal to help patients, caregivers and family members all over the world who suffer from this debilitating central nervous system disease,” Hampel stated.

Irizarry joined Eisai in 2018 as vice president, Clinical Research for its Epilepsy and Sleep/Wake therapeutic areas. He will take on a new role overseeing the clinical development and overall strategy of Eisai’s AD-related neurosciences portfolio. Before joining Eisai, Irizarry held leadership roles in neuroscience at Eli Lilly and in epidemiology at GlaxoSmithKline. Prior to moving to industry, he was a researcher at the Massachusetts Alzheimer’s Disease Research Center.

Irizarry received both his undergraduate and MD from Georgetown University. He earned a Master of Public Health from the Harvard School of Public Health. He performed his neurology residency and Memory Disorders Fellowship at Massachusetts General Hospital.

“I am excited to work with the groundbreaking researchers at Eisai to advance the Alzheimer’s portfolio towards bringing urgently needed, transformative symptomatic and disease-modifying therapies to patients,” Irizarry stated.

“The additions of Dr. Hampel and Dr. Irizarry are a very important step as Eisai continues to break through in its quest to develop the first disease-modifying therapy for patients with Alzheimer’s disease,” stated Lynn Kramer, chief clinical officer and chief medical officer, Neurology Business Group at Eisai. “Every day, the number of patients diagnosed with AD and dementia continues to grow with little hope for them, their caregivers and families. Through the efforts of our talented employees and our commitment to our human health care mission, we are confident that we can someday offer a complete treatment regimen that is preventative, pre-emptive, restorative and regenerative.”