CEO statement on August 23, 2018 (Interim Report January-June 2018):
On July 25, the 18 month results from the Phase 2b study with BAN2401 in 856 patients with early Alzheimer’s disease were presented by our partner Eisai at the Alzheimer’s Association International Conference (AAIC) in Chicago. The detailed results of the study are very encouraging, showing consistent dose-dependent, clinically meaningful and statistically significant effects of BAN2401 on several clinical endpoints, as well as biomarkers including PET, combined with a good tolerability profile.
At the readout after 18 months of treatment an effect with dose-dependent slowing of cognitive decline from baseline on ADCOMS was demonstrated. The highest BAN2401 dose of 10 mg/kg twice a month demonstrated a significant slowing of clinical decline of 30% compared to placebo. A statistically significant slowing of decline on ADCOMS was observed as early as 6 months as well as at 12 months. Dose-dependent slowing of cognitive decline was also observed on the well-established cognition scale ADAS-Cog with 47% slower decline for the highest dose of BAN2401.
For disease-modifying treatments it is also important to show effect on biomarkers for example on amyloid. Highly statistically significant effects were observed for all BAN2401 dose groups in the study. At the highest dose, using standardized PET as measured with the Centiloid scale, the mean reduction in accumulated amyloid in the brain was approximately 70 units at 18 months. The observed baseline mean was 74.5 units, observed 18-month mean was 5.5 units. In amyloid PET image visual read BAN2401 demonstrated a dose-dependent improvement with 81% of patients converting from amyloid positive to amyloid negative status at 18 months at the highest dose.
A good tolerability profile was also reported for BAN2401 in the study. This is important since the treatment of the patients starts at an early stage of the disease.
This is the first late stage clinical study demonstrating potential disease-modifying effects (on several different scales) on both cognition and biomarkers with a good tolerability profile. The study gives new hope for patients and their families. These positive results are also important for BioArctic, Eisai and Biogen as well as for the Alzheimer field of research
The long term and successful collaboration with Eisai has also led to the identification of a new biological target, for which BioArctic recently has obtained exclusive rights to develop antibody treatments for Alzheimer’s disease.
The research collaboration with AbbVie in the Parkinson’s disease program progresses well in line with the agreed project plan. According to the collaboration agreement, BioArctic has the primary responsibility for the preclinical research phase. The Parkinson’s disease program has developed well and consists of three preclinical projects; BAN0805, PD1601 and PD1602, all antibodies targeting alpha-synuclein. During the fall, we will focus on delivering the preclinical activities with the drug candidate BAN0805 as efficiently as possible, preparing for clinical development and for start-up of clinical studies in the U.S. (IND). The goal is to start the first clinical study during 2019.
In April we announced that the inclusion of patients in the first of three panels in the company’s ongoing Phase 1/2 study with the product candidate SC0806, for the treatment of complete spinal cord injury, had been completed. BioArctic has now also regulatory approvals to include Finnish patients. Patients from Sweden, Estonia, Norway and now also Finland can thus be recruited to the next two panels of the study.
In May BioArctic received the SwedenBIO Award 2018, a joyful event for all of us in the company.
BioArctic’s most important task is to improve the quality of life for patients with diseases in the central nervous system. I am proud of the positive development of the project portfolio. In addition, we can again report a positive financial result. BioArctic is well positioned to advance the projects towards our goals and new potential collaborations in line with the company’s strategy.
I am looking forward to continue to progress the company’s innovative projects in our three treatment areas, which all have great medical needs, and to all our important activities in the fall. Finally, I would like to express my thanks to all who have contributed to the positive development of BioArctic.