CEO Gunilla Osswald presents BioArctic

CEO comments on April 22, 2020 (Interim Report January – March 2020):

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

BioArctic’s work towards providing patients suffering from neurodegenerative disorders access to effective treatments and improved diagnostics continues to make solid progress. The impact of COVID-19 on society at large, on the global economy and on people’s daily lives is both alarming and difficult to process. Under the present circumstances, I am pleased that we have so far been able to continue our operations without noteworthy disruptions. Our success in building up cash reserves of more than SEK 1 billion is a great source of comfort in a situation where the financial markets are rife with uncertainty. BioArctic has a business model in which our partners conduct and finance the major clinical trials in Alzheimer’s and Parkinson’s diseases. This makes it possible for us to focus on our own innovative pre-clinical projects and on developing the medicines of the future for patients with disorders of the central nervous system.

Eisai, our partner in the field of Alzheimer’s disease, continues to show a high degree of commitment to our most advanced drug candidate, BAN2401, and the program continues to expand. BAN2401 is being evaluated in a confirmatory Phase 3 study in patients with early Alzheimer’s disease, and we note that the study has recently been expanded into several more countries. It is especially gratifying for us to note that Sweden is also part of the study, and that the first patients have now been enrolled. The aim with the Phase 3 study is to confirm the positive results of the Phase 2b study, as well as to form the basis for market registration. Eisai expects results from the study to become available in 2022.

At the same time, the open-label extension study continues with patients who took part in the previously completed Phase 2b study. The promising initial results were presented late last year and we look forward to the continued follow-ups. Furthermore, Eisai is preparing a broad Phase 3 program (AHEAD 3-45) in partnership with the Alzheimer’s Clinical Trials Consortium (ACTC) aimed at preventing Alzheimer’s disease by administering BAN2401 in the earliest stages of disease development. The program consists of two sub-studies with approximately 1,000 and 400 subjects, respectively.

In the Parkinson’s disease area, our partner AbbVie has initiated recruitment for the second part of the ongoing Phase 1 program, in which our outlicensed drug candidate ABBV-0805 will be evaluated in patients for the first time. In parallel, we are focusing on delivering the subsequent projects that are included in this successful collaboration with AbbVie. The reputable periodical Drug Discovery Today recently published an article regarding the effective collaboration between BioArctic and AbbVie in Parkinson’s disease. Being seen as an appreciated collaborating partner is a mark of quality for BioArctic and is important for our future projects and potential partners. It is our hope that ABBV-0805 will be one of the first disease-modifying treatments for Parkinson’s disease, which is devastating to quality of life for patients and which incurs large costs to society.

Our pre-clinical portfolio also continued to develop well during the first quarter, with the added project in Alzheimer’s disease and a project that is believed could impact several different neurodegenerative disorders. At the same time, we are working further on our diagnostics projects, the purpose of which is to identify people with neurodegenerative disorders at an early stage. Research is ongoing into our unique blood-brain barrier technology, which improves the passage of antibody drugs into the brain. In pace with securing patent protection for our projects, we will become increasingly transparent in terms of the progress we are making.

Our innovative and broad portfolio, the extensive collaborations with international pharma companies, our support in the academic community and a strong cash position make BioArctic a unique Swedish biopharma company. Our projects, focused on disorders of the central nervous system, are tremendously important in our ambition to improve life for these patients.

Gunilla Osswald
CEO, BioArctic AB