Developing disease modifying treatments against Alzheimer’s disease
Epidemiology and current treatments
Alzheimer’s Disease is a neurodegenerative disease affecting millions of patients, and their loved ones, around the world. To date, about 30 million individuals live with Alzheimer’s disease at different stages. The disease is characterized by death of neurons in the brain causing a progressive deterioration of memory and cognitive skills, such as intellectual ability, language, orientation, recognition and learning ability. The disease can lead to personality changes and psychiatric symptoms, for example; apathy, depression, disorientation, paranoia, aggressiveness, and motor symptoms, such as stiffness, reduced mobility and impaired responsiveness.
Research has long faced major challenges in developing effective drugs against Alzheimer’s disease, and patients have had to settle for treatments that only temporarily alleviates the symptoms. But, over the past decade, science has made important discoveries that form the foundation for a new era of treatments that impact the cause of the disease.
BioArctic’s research is at the forefront of this development, and lecanemab has become one of the world’s first drugs that not only alleviate the symptoms but also slow the underlying progression of the disease.
Our solution
The cause of Alzheimer’s disease is believed to lie in the misfolding and aggregation of the amyloid-beta protein, resulting in the formation of soluble toxic aggregated forms. Importantly, the monomeric form of amyloid-beta present in most tissues and body fluids, is described as harmless. But in Alzheimer’s disease, the monomeric amyloid-beta forms aggregates. These aggregates grow in size an eventually form insoluble fibrils that accumulate in brain tissue as plaques.
The result of our ground-breaking research shows that the specific forms of soluble aggregated amyloid-beta species, known as oligomers and protofibrils, are the most harmful forms to nerve cells. Our engineered antibodies produced using well implemented strategies target these and other harmful forms of amyloid-beta in very specific ways.
BioArctic has several drug projects for treatment of Alzheimer’s disease which approach the underlying pathologies in different ways, of which lecanemab is approved on several markets.
Lecanemab slows the progression of Alzheimer’s disease
Lecanemab is an antibody targeting oligomers and protofibrils, the most harmful forms of Ab. Since 2007, lecanemab is licensed to Eisai.
In September 2022, lecanemab showed positive results in the pivotal Phase 3 study, Clarity AD, in early Alzheimer’s disease, and both the primary and all key secondary endpoints were met with high statistical significance. In addition, there is an ongoing Phase 3 study (AHEAD 3-45) in persons who have not yet developed symptoms of Alzheimer’s disease but have intermediate or elevated amyloid levels in the brain.
Lecanemab is approved in the U.S., Japan, EU, China, Great Britain, and several other markets for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. In EU and UK, lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers and the medicinal product is subject to additional monitoring.
Additional antibodies under development
We are also conducting research into generating new antibodies intended for treatment of Alzheimer’s disease with the goal of slowing or stopping disease progression with innovative molecules that have different mechanisms of action. We have additional antibody projects against Alzheimer’s disease in the project portfolio, all of which are in the research phase.
Follow our research on the Pipeline page.