CEO comments on February 6, 2020 (Full Year Report January – December 2019):
2019 was a successful year that resulted in an enhanced project portfolio. The portfolio is balanced and competitive, consisting of unique product candidates, technology platforms and diagnostic tools. All our projects are focused on disorders of the central nervous system. During the year, two drug candidates, BAN2401 and ABBV-0805, advanced to the next clinical phase in their respective development programs. With the decision to stop further development in the spinal cord injury project, our research is focused on neurodegenerative disorders. During the quarter, our portfolio expanded with two new projects in early research phase.
The BAN2401 project for Alzheimer’s disease continues to develop well. Our partner, Eisai, is strongly committed to the overall development of BAN2401 and is either conducting or planning three clinical studies. This past spring, based on the positive outcomes of the large Phase 2b study, Eisai started the global confirmatory Phase 3 study (Clarity AD) with BAN2401 in early Alzheimer’s disease. Eisai has stated that they expect results from the Phase 3 study in 2022. The Phase 2b extension study is ongoing and Eisai presented data from the study at the CTAD conference (Clinical Trials on Alzheimer’s Disease) in December. The data showed that amyloid reductions in the brain that occurred as a result of treatment with BAN2401 persisted after the conclusion of treatment. Differences in benefits on clinical outcomes were maintained after BAN2401 treatment in the two highest dose groups as compared with the placebo group. Eisai and Alzheimer’s Clinical Trials Consortium are preparing a clinical Phase 3 program with BAN2401 aimed at prevention of Alzheimer’s disease starting in 2020.
The unique binding profile of BAN2401 has been confirmed in data presented during the year. Professor Lars Lannfelt presented data on BAN2401’s binding profile at the CTAD conference. All in all, the results strengthen our conviction that BAN2401’s binding profile is important and distinguishes it from other amyloid-beta antibodies. During the quarter, BioArctic initiated a research collaboration with Eisai aimed at further studying BAN2401’s unique profile. We look forward to presenting more data on BAN2401’s characteristics at the AAT-ADPD meeting in April in Vienna.
In the Parkinson’s program, BioArctic’s partner AbbVie continues the Phase 1 study of the drug candidate ABBV-0805. During the year, we continued to pursue two projects in research stages, in partnership with AbbVie, and we have delivered our commitments according to plan. This means we will soon have completed the preclinical activities of this ongoing collaboration.
In November, BioArctic announced the results from the interim analysis from the Phase 1/2 study with SC0806 for treatment of patients with complete spinal cord injuries. The results showed no convincing effects on the primary or secondary endpoints of the study. Even though it was disheartening that the SC0806 treatment did not have the effect the preclinical results indicated, we contributed with the Phase 1/2 study to increased knowledge about spinal cord injuries. We will conclude the study in a responsibly manner. BioArctic’s decision to close the entire project means we will continue to focus on our core operations: research and development of drugs for Alzheimer’s, Parkinson’s and other disorders of the central nervous system.
Our project portfolio continues to expand, and now includes two new projects in the research phase: one aimed at Alzheimer’s disease and one with potential in various CNS disorders. Additionally, development in our blood-brain barrier technology platform is progressing favorably. The technology is intended to facilitate the passage of antibodies into the brain. We are looking forward to developing the projects and the technology platform over the coming years.
The management team and the organization overall have been strengthened so that the company can take advantage of the many opportunities with the project portfolio. In January, our new Chief Medical Officer (CMO) took up office. The former CMO remains with the company in another senior role.
BioArctic’s cash and overall financial position remain strong and our strategic partners finance and conduct the costly clinical studies in Alzheimer’s and Parkinson’s diseases. This creates the possibility for the continued positive development of the project portfolio.
We have had another successful year resulting in an expanded and strengthened project portfolio. I am proud to lead this innovative company and pleased, along with my colleagues and partners, to generate the medicines of the future for patients with central nervous system disorders.