CEO Gunilla Osswald presents BioArctic

CEO comments on April 21, 2021 (Interim Report January – March 2021):

“Lecanemab continues to prove effective in reducing amyloid-beta in the brain.”

The 15th International Conference on Alzheimer’s and Parkinson’s diseases and related neurological disorders was held in March. The conference is one of the year’s most important scientific forums in neurological diseases, gathering researchers and companies from around the globe. The new developments and analyses that were presented provided important information about developments in the field. In summarizing our impressions from this year’s conference, we can confirm that scientific support has further increased for anti-amyloid beta antibodies that reduce harmful forms of amyloid in the brain, alleviate the symptoms, and slow the progress of the disease in patients with Alzheimer’s disease. Today, there are four antibodies against amyloid-beta that are in the late clinical development phase. Of these, lecanemab and two others have already demonstrated clinical effect.

At the same time, understanding of how crucial the binding profiles of individual antibodies are for achieving a positive clinical effect and reducing the risk of side effects is increasing. Lecanemab, the drug candidate generated by BioArctic and developed by Eisai, stands out with its unique and highly specific binding profile. By binding selectively to the soluble aggregated forms of amyloid-beta — oligomers and protofibrils, the forms most toxic to nerve cells — lecanemab has been shown to remove amyloid-beta quickly and effectively from the brain.

During the conference, Eisai presented new data from the open-label extension study of the Phase 2b study in early Alzheimer’s disease that further strengthens lecanemab. We can now state that more than 80 percent of the patients who received the highest dosage of lecanemab, both in the core study and in the open-label extension study, showed reduction of amyloid-beta to non-pathological levels when their brains were studied using diagnostic imaging. This effect can be seen after only 12 months of treatment. Lecanemab also has a continued low occurrence of ARIA-E compared to such side effects reported by competitors’ antibody therapy under development. At the same time as the promising results from the open-label extension study are being presented, the large global Phase 3 study of lecanemab in 1,795 patients with early Alzheimer’s disease is under way, and according to Eisai the results of the study are expected in September 2022.

During the AD/PD Conference, we were able to present results for the first time from our own research concerning Down’s syndrome with dementia. Persons with Down’s syndrome suffer from dementia to a much greater extent than others, and our research has now confirmed that these individuals have significantly elevated levels of the soluble aggregated forms of amyloid-beta (oligomers and protofibrils) compared with the control group. In other words, the pathology is similar to that seen in Alzheimer’s disease. Treatment with lecanemab therefore has the potential to slow the development of dementia in these individuals.

The latest developments in Parkinson’s disease were also in focus during the AD/PD Conference. New clinical data from the Parkinson’s projects of other pharma companies provided important learnings concerning the design of the Phase 2 study that our partner, AbbVie, is now preparing for ABBV-0805, the drug candidate outlicensed by BioArctic. In Parkinson’s disease as well, it is clear that the binding profile is crucial to how well an antibody will function.

Our research into the blood-brain barrier and the technology which we call Brain Transporter and is intended to facilitate the transport of antibodies into the brain, continues to perform well and we now have two Alzheimer’s projects in progress linked to our technology.

When I hear about all the research being conducted into the central nervous system, it strengthens my conviction that BioArctic’s research is on the global leading edge. It was therefore particularly gratifying recently to have the honor of presenting BioArctic and our vital research at a digital meeting, arranged by the Confederation of Swedish Enterprise, with the Swedish Royal Family. The royal family showed an impressive level of engagement in these crucial questions.

In summary, the research being conducted by our fantastic employees holds great promise and has the potential to make a big difference for patients around the world.

Gunilla Osswald
CEO, BioArctic AB