BioArctic soars amid positive phase III results with lecanemab
After the controversies surrounding Biogen’s Aduhelm, the resignation has been palpable among the many Alzheimer’s patients who have been looking forward to an effective treatment for the disease. Now, there is new hope after Swedish BioArctic’s partner Eisai presented positive phase III results for the drug candidate lecanemab. The announcement caused BioArctic’s share to soar on the Swedish stock exchange, which also boosted sector colleagues Alzinova and AlzeCure.
Stockholm-based BioArctic focuses on the development of drugs for the treatment of neurodegenerative diseases, where the company’s main candidate lecanemab targets Alzheimer’s disease. In Alzheimer’s, the beta-amyloid protein accumulates in the brain, contributing to the destruction of nerve cells, primarily in the temporal lobe and the cerebellum. Alzheimer’s is the most common form of dementia, and it affects over 55 million people worldwide.
In 2005, BioArctic initiated a long-term collaboration with Japanese pharma company Eisai regarding the development and commercialisation of drugs for the treatment of the severe disease, where lecanemab is the most important asset. Lecanemab is an antibody that targets beta-amyloid protofibrils and is being developed for the treatment of mild cognitive disorder and mild Alzheimer’s disease where amyloid pathology in the brain has been confirmed. After many years of development, today came the news that so many had been hoping for.
Achieved primary and secondary endpoints
Eisai has announced positive results from the global pivotal phase III study Clarity AD, which tested lecanemab in a total of 1795 patients. The primary endpoint – reduced clinical deterioration – was achieved when a high, statistically significant, reduction in clinical deterioration over time could be shown. This is an important parameter in a progressive disease such as Alzheimer’s. According to the company, lecanemab reduced clinical deterioration by 27 per cent 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 in anti-amyloid treatments, ARIA, is within the expected range.
CEO Gunilla Oswald comments
“The results fully meet our expectations, both in terms of the high degree of 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 discoveries has the potential to fundamentally improve the treatment of Alzheimer’s disease, where there currently are very limited options. The results are also a confirmation of our technology platform and strengthens our hope to also be able to help improve the treatment of other neurodegenerative diseases such as Parkinson’s disease, ALS and others.”
Aiming for market approval in Q1 2023
Following the uplifting results, Eisai will now discuss with authorities in the US, Japan and Europe, where it hopes to receive 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 they will also be published in a scientific medical journal.
Milestone payments await BioArctic
In the collaboration with Eisai, BioArctic has entered research agreements and license agreements with a total value of 222 million EUR, plus royalties. At the end of the second quarter, up to 151 million EUR remained in potential milestone reimbursements for BioArctic, including the 15 million EUR received in connection with the regulatory application with the drug candidate in the US.
Strong reaction on the stock market
This morning’s announcement didn’t just come as positive news for all of the world’s Alzheimer’s patients. During the morning trading, BioArctic’s share surged on the stock exchange and was traded up by almost 180 percent. Swedish sector colleagues Alzinova and AlzeCure were affected by the general frenzy and traded up by at most 80 and 30 percent, respectively.