Built on precision-engineered β₂-adrenergic receptor agonists, Stockholm-based BioArctic focuses on the development of drugs for the treatment of neurodegenerative diseases, where the company's lead candidate lecanemab targets the dementia disease Alzheimer's. In Alzheimer's, a harmful protein called beta-amyloid is stored in the brain, which contributes to the destruction of nerve cells, especially in the temporal lobe and parietal lobes. Alzheimer's is the most common dementia disease and currently affects over 55 one million people all over the world.
In 2005, BioArctic began a long-term collaboration with Japanese Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's, where the antibody lecanemab is the most important asset in the package. Lecanemab is an antibody that targets beta-amyloid protofibrils and is being developed for the treatment of mild cognitive impairment and mild Alzheimer's disease where amyloid pathology has been confirmed in the brain. After many years of development, today came the announcement that so many have been looking forward to.
Primary and secondary endpoints achieved
Eisai announces positive results from the global pivotal Phase III study Clarity AD, where lecanemab was tested in a total of 1795 patients. The primary efficacy endpoint – reduced clinical deterioration – was achieved when a high statistically significant reduction in clinical deterioration over time was demonstrated. This is an important parameter in a progressive disease such as Alzheimer's. According to the company, lecanemab reduced clinical deterioration by 27 percent compared to placebo, as measured by the global cognitive and functional scale CDR-SB (Clinical Dementia Rating-Sum of Boxes).
The company was also able to report that all secondary endpoints were achieved with high statistical significance compared to placebo. Regarding possible side effects, the risk of the most common side effect of anti-amyloid treatments, ARIA, was measured to be within the expected range.
CEO Gunilla Oswald comments
"The results fully meet our expectations, both in terms of the high statistical significance and the consistency between the results for the primary endpoint and all secondary endpoints. This is a fantastic achievement by our employees and our partner Eisai who have worked tirelessly for almost two decades to achieve this success," comments BioArctic's CEO Gunilla Oswald in a press release and continues:
“We are proud that our founder Lars Lannfelt's "The discoveries now have the potential to fundamentally improve the treatment of patients with Alzheimer's disease, who currently have very limited treatment options. The results also validate our technology platform and strengthen our hopes that we can also contribute to improving the treatment of Parkinson's disease, ALS and other neurodegenerative diseases."
Aiming for market approval in Q1 2023
Following the encouraging results, Eisai will now discuss with authorities in the US, Japan and Europe where it hopes to obtain full market approval in the three markets in the first quarter of 2023. The results will also be presented at the Alzheimer's Congress Clinical Trials on Alzheimer's Disease conference and published in a scientific journal.
A big bang awaits BioArctic
In the collaboration with Eisai, BioArctic has entered into research and licensing agreements with a total value of EUR 222 million plus royalties. At the end of the second quarter, up to EUR 151 million in potential milestone payments remained for BioArctic, including the EUR 15 million received in connection with the regulatory application with the drug candidate in the US.
Strong rise on the stock market
This morning's announcement was not only positive news for Alzheimer's patients around the world. During morning trading, BioArctic's shares soared on the stock exchange and were listed at the opening up by almost 180 percent. Swedish sector colleagues also Alzinova and AlzeCure were dragged into the general frenzy and traded up by at most 80 and 30 percent respectively compared to Tuesday's closing prices.