CEO comments on July 11, 2019 (Interim Report January – June 2019):
Significant progress in the projects and additional milestone payment
In the first half of 2019, BioArctic made significant progress in that all three clinical projects advanced to the next phase in their respective development program and all of our research projects continued to generate results. All in all, this means that we have had a very successful first half of the year.
The global, confirmatory Phase 3 study (Clarity AD) has been started with the drug candidate BAN2401, a potential disease modifying treatment for early Alzheimer’s disease. In May, the first patient was dosed which triggered a milestone payment of MEUR 15 to BioArctic from our partner Eisai. This large Phase 3 study, which is intended to support a regulatory filing, is based on the positive results from the Phase 2b study. According to Eisai, the final readout of the primary endpoint of the study is targeted for 2022.
The Phase 2b study with BAN2401 was the first study in late clinical phase to have successfully demonstrated potential disease modifying effects on both clinical function and clearance of amyloid beta in the brain. Further, the Phase 2b study also demonstrated effects on neurodegenerative biomarkers. These consistent results strengthen BioArctic’s belief that BAN2401’s unique binding profile is important and differentiates it from other antibodies.
For the participants in the Phase 2b study, an open-label extension study is ongoing with continued BAN2401 treatment with the highest dose and without placebo control.
BAN2401 has also recently been selected by the Alzheimer’s Clinical Trials Consortium (ACTC) to be evaluated in a clinical trial aimed at prevention of Alzheimer’s disease (the A45 study). According to ACTC and Eisai, the trial will be starting in early 2020. We are pleased to note Eisai’s strong commitment to the continued clinical development of BAN2401 in Alzheimer’s disease.
In the Parkinson’s program, our partner AbbVie started the Phase 1 study with the drug candidate ABBV-0805. AbbVie is responsible for running the clinical program and its financing. Within the framework of the collaboration, BioArctic continues to conduct two additional projects in research stages with antibodies targeting alpha-synuclein for treatment of Parkinson’s disease.
Also, the Alzheimer projects as well as the projects on diagnostics and technologies in research phase have continued to develop well. In collaboration with Uppsala University, BioArctic develops a technology platform that facilitates the passage of antibodies across the blood-brain barrier. This innovative technology could potentially be used to treat various diseases of the brain. We have recently recruited an internationally renowned scientist to further strengthen the company’s capabilities and competence in the neuroscience therapeutic area, antibody engineering and blood-brain barrier technology.
The product candidate SC0806 for complete spinal cord injury has advanced into Phase 2 in the ongoing Phase 1/2 study. An interim analysis of the first panel concerning efficacy and safety is planned for the first half of 2020, at the latest.
An important step to attract and retain competence in the company is the new employee warrant program which currently is being implemented. I am proud of our successes and to lead this innovative company with the aim to improve the quality of life for patients with central nervous systems disorders.