CEO statement on April 26, 2018 (Interim Report Jan-Mar 2018):
BioArctic’s most important task is to improve the quality of life for patients with diseases in the central nervous system. We have continued to progress the company’s innovative projects in the three treatment areas, which all have great medical needs, well in line with our objectives.
During this quarter, BioArctic obtained regulatory approval in Estonia and Norway for including patients with complete spinal cord injury in the company’s ongoing Phase 1/2 study with the product candidate SC0806. Work is in progress to also include specialist clinics in Finland in the study. In April, the inclusion of patients with complete spinal cord injuries in the first panel of three was completed in the ongoing clinical study with SC0806. The product candidate is a combination of a medical device and a drug. BioArctic’s patent was granted by the patent offices in the US and Japan for the medical device which is one of the main components of SC0806 during the period. Today there is no effective treatment for patients with complete spinal cord injury and the patients require life-long therapy and care, which means high costs for the society.
Among BioArctic’s five projects for treatment of patients with early Alzheimer’s disease BAN2401, in collaboration with Eisai, is the one that has advanced furthest. On December 21, 2017 BioArctic announced that the Phase 2b study with BAN2401 in 856 patients with early stage Alzheimer’s disease will continue towards final analysis after 18 months treatment, and that the ADCOMS efficiency criteria (primary endpoint) was not met at a 12-month interim analysis based on an innovative Bayesian design with high requirements for meeting the efficiency criteria. According to the predetermined study protocol, the trial will continue to completion and remain blinded. 18 months is considered to be a more relevant treatment period for demonstrating clinical effect of a disease modifying drug for Alzheimer’s disease. We look forward to the results at completion of the 18 months treatment that are expected to be available during the third quarter 2018. Final results after completed study with 18 months treatment, including the three months follow-up of the patients, are expected to be available during the fourth quarter 2018.
The research collaboration with AbbVie in Parkinson’s disease progressed well according to the agreed project plan. According to the collaboration agreement, BioArctic has the primary responsibility for the preclinical research phase. Focus is on conducting the preclinical activities with the drug candidate BAN0805 as efficiently as possible preparing for the clinical development and for the application of the start-up of clinical studies in the U.S. (IND).
During the period we have strengthened the organization with additional cutting-edge expertise and resources with new employees and key consultants who quickly have adapted to their roles and the operations.
I am pleased with the continued progress of the project portfolio during the quarter and that BioArctic continued to show a positive financial result. BioArctic is well positioned to carry the projects forward towards our goals and potential new collaborations in accordance with the company’s strategy. In conclusion, I would like to thank all who have contributed to a successful quarter and start of the fiscal year 2018.