CEO Gunilla Osswald presents BioArctic

CEO comments on October 14, 2020 (Interim Report January – September 2020):

“Our ambition is to develop the medicines of the future with the aim of improving life for people with disorders of the central nervous system.”

Almost exactly three years ago, on October 12, 2017, BioArctic initiated its public offering at Nasdaq Stockholm. Since then, our drug projects against Alzheimer’s disease and Parkinson’s disease have made significant advances, new projects have been added and the company’s market value has more than tripled. We are proud and pleased to have developed the company into one of the foremost in the world today in the development of disease-modifying treatments for neurodegenerative disorders such as Alzheimer’s disease and Parkinson’s disease. These diseases cause a great deal of suffering, limit the quality of life for millions of people, and give rise to enormous costs to society.

BioArctic continued its positive performance this quarter as well. Eisai, our partner in Alzheimer’s disease, initiated an additional broad Phase 3 program with BAN2401 together with the Alzheimer’s Clinical Trials Consortium (ACTC). The intent of the program is to study the benefit of treatment in the very earliest stages of Alzheimer’s disease, before the emergence of symptoms. The new and extremely ambitious program, which is expected to encompass 1,400 persons, emphasizes Eisai’s strong commitment to BAN2401 and, if successful, could enable more people in the future to have access to a treatment with the potential to slow the progress of the disease.

At the same time, the Clarity-AD Phase 3 study is continuing with BAN2041, the purpose of which is to confirm the positive results of the Phase 2b study. Eisai expects the study to be fully enrolled by the end of the year, and the results of the study to be available in 2022. This past summer, new data, from the open-label extension of the previously concluded Phase 2b study with BAN2401, was presented that was consistent with the previously shown biomarker effect and safety profile. The patients who received placebo in the earlier study and are now being treated with BAN2401 have shown a rapid and continual decrease in amyloid levels after three and additionally after six months and twelve months. The occurrence of the ARIA-E side effect remains low: less than 10 per cent of the patients studied. Results from the effect on clinical outcomes are expected to be presented in the future.

BioArctic has a project portfolio with several promising proprietary preclinical projects with the aim to develop next generation medicines. Today, more than 30 million people suffer from Alzheimer’s disease, a number that unfortunately is expected to rise dramatically over the next few decades as populations age. We recently informed that one of our preclinical projects, AD1801, is linked to ApoE, which is the most common genetic risk factor for the disease. This new approach creates additional opportunities to develop alternative treatments for Alzheimer’s disease.

Our collaboration with AbbVie to develop a new type of treatment against Parkinson’s disease continues to progress well. A comprehensive Phase 1 study with ABBV-0805 is in progress, and AbbVie recently decided to halt recruitment for the second part of the Phase 1 study to instead develop a detailed plan for advancing the drug candidate to a Phase 2 study. ABBV-0805 has the potential to become one of the first disease-modifying treatments for Parkinson’s disease, which could improve quality of life for patients.

With committed, highly specialized and experienced employees, dedicated academic and global industrial partners as well as approximately SEK 1 billion in cash, we will continue our work to bring new effective medicines to patients. In the portfolio of early projects, the focus is on our efforts in the blood-brain barrier technology and on our own drug projects oriented to disorders of the central nervous system. As a consequence of the COVID-19 pandemic, we have adjusted our work processes, and it is gratifying to see that the company’s own projects continue to develop as planned. After three successful years as a listed company, we are continuing our work to be able to offer disease-modifying treatments for patients with neurodegenerative disorders, all based on high-quality research resting on a solid scientific basis.

Gunilla Osswald
CEO, BioArctic AB