CEO Gunilla Osswald presents BioArctic

CEO comments on October 24, 2019 (Interim Report January – September 2019):

BioArctic focuses where high unmet medical needs exist for patients with central nervous system disorders. Our work is based on groundbreaking scientific discoveries. Our team works in close collaboration with leading competences in academia and large pharma partners.

This quarter, we received further validation for our innovative and world-leading science that is the foundation for our work to develop a safe and effective treatment for Alzheimer’s disease. During the Alzheimer’s Association International Conference (AAIC) in July, BioArctic’s co-founder, Professor Lars Lannfelt, received a Lifetime Achievement Award, one of the world’s most prestigious awards in Alzheimer’s disease research, for his discoveries and research that led to the drug candidate BAN2401. We are delighted and proud that
Lars Lannfelt is recognized for his important scientific contribution to the field and to BioArctic’s research.

The antibody BAN2401 is specifically designed and generated to selectively bind to and eliminate the harmful forms of amyloid beta, called protofibrils, which are believed to lead to the development of Alzheimer’s disease. This unique binding profile was further confirmed with new data presented in July at the AAIC. The results are consistent with what has been seen in previous studies with BAN2401, but also confirmed that BAN2401 is different from other amyloid beta antibodies. As previously presented, the large Phase 2b study with BAN2401 successfully demonstrated consistent effects on clinical function and biomarkers of disease, as well as a good safety profile. Our partner Eisai presented additional supportive data from this study at the AAIC in July. Taken together, these results strengthen BioArctic’s belief that BAN2401’s unique binding profile is important and differentiates it from other antibodies’.

Our partner Eisai has continued to develop BAN2401 in a stepwise fashion, taking each next step based on strong data from the previous phase. Based on the results from the Phase 2b study, the global, confirmatory Phase 3 study (Clarity AD) with BAN2401 is well underway and Eisai expects to receive study results in 2022. Eisai is also strongly committed to the overall development of BAN2401. In addition to the ongoing Phase 3-study, a Phase 2b open-label extension study with BAN2401 is ongoing and a further clinical trial aimed at prevention of Alzheimer’s disease with BAN2401 is planned to start in 2020.

BioArctic’s balanced portfolio, with projects from discovery to late clinical phase, has developed well. During the year, three projects advanced to the next clinical phase in their respective development program.

In the Parkinson’s program, our partner AbbVie continues the Phase 1 study with the drug candidate ABBV-0805. BioArctic continues to pursue two further research phase projects within the framework of the ongoing collaboration with AbbVie.

With SC0806, intended for complete spinal cord injury, the trial has advanced as planned and we expect to receive the results of the interim analysis of the first panel of the study in Q4 2019/Q1 2020. This will be the first time we analyze the effect of SC0806, in addition to safety.

The technology platform to facilitate passage of antibodies over the blood-brain barrier is developing well. We are grateful for the grant that we and Uppsala University received together from Vinnova (Sweden’s innovation agency) earlier this year. We are also pleased to have successfully recruited world-leading scientists in this area. The research is at an early stage but has already shown very promising results and the technology has great potential in the treatment of various brain diseases.

BioArctic’s finances remain strong. Our strategic partners fund and progress the costly clinical studies in Alzheimer’s and Parkinson’s diseases. Grants primarily fund the clinical development for our complete spinal cord injury project. Furthermore, our partnered projects’ progress brings revenues to BioArctic, including the most recent MEUR 15 milestone from Eisai for the start of the Phase 3 clinical study for BAN2401 in May 2019.

Our ambition is to develop the medicines of the future that change life for people with central nervous system disorders. The company’s strong cash position creates the opportunity for the continued exciting development of BioArctic.