CEO comments on February 14, 2019 (Full Year Report 2018):
Looking back at the past year, I am amazed that so much can happen is such a short time. 2018 was an exciting and successful year, with three especially important events.
The first event was the positive 18 months results from the BAN2401 Phase 2b study with 856 patients with early Alzheimer’s disease. This is the first study in late clinical phase that has demonstrated a disease modifying effect on clinical function as well as reduced aggregation of amyloid beta in the brain, and with good tolerability. The data support the positive effect of BAN2401 in all the subgroups of early Alzheimer patients.
BAN2401 is one of very few projects that have demonstrated reduction of amyloid in the brain and clinical effect. BAN2401 selectively binds to the toxic aggregated forms of amyloid-beta in the brain. The results with BAN2401 and other projects so far suggest that the antibody’s binding profile is important.
Our partner Eisai is discussing the next stage in the development of BAN2401 with regulatory authorities and is preparing for initiation of a single Phase 3 confirmatory study within the first quarter 2019.
A second positive event was the out-licensing of BioArctic’s portfolio of antibodies to alpha-synuclein for Parkinson’s disease and other potential indications to our partner AbbVie. The licensing triggered a milestone payment of 50 MUSD. AbbVie will continue to develop BAN0805, now with the designation ABBV-0805. FDA recently approved the IND-application for ABBV-0805. The first clinical study is planned to start in 2019.
The third event was that the inclusion of patients in the first of BioArctic’s three panels in the ongoing Phase 1/2 study with SC0806 for the treatment of complete spinal cord injury was completed. In addition, we received approvals enabling inclusion of patients also from Estonia, Finland and Norway in the coming panels in the study. Recently, the Phase 2 part of the study has started and the first patient has received treatment with SC0806. An interim analysis of the first panel regarding efficacy and safety is planned no later than first half of 2020.
The company’s early projects have progressed well during the year. BioArctic obtained exclusive rights to develop potential antibody treatments (AD1801), an entirely new target, for Alzheimer’s disease from a research project jointly owned with Eisai.
During the year, BioArctic has extended research collaborations with universities concerning biomarkers and technologies for better passage of antibodies across the blood-brain barrier.
The recent accomplishments in the projects have created a very good basis for a bright future for BioArctic. I am pleased to lead this innovative company and with all co-workers continue our work to improve the quality of life for patients with central nervous system disorders. Finally, I would like to thank all who have contributed to a successful 2018.