On February 3, Biogen announced in its 2020 annual performance and earnings report that the highly-regarded Parkinson’s disease drug candidate cinemaneab (BIIB054) did not reach the primary and secondary endpoints in the Phase 2 clinical study of SPARK.
The SPARK study analyzed the efficacy of the anti-α-synuclein (syn) monoclonal antibody cinemaneab in reducing injury and disability in Parkinson's disease patients compared with placebo. The primary endpoint is the improvement of the MDS-UPDRS total score. Bojian initially hoped that the drug could successfully compete with Roche and Prothena's syn therapy prasinezumab. But because the therapy "has not reached the proof-of-concept" and failed to provide patient benefits in the study, the development of cinemamab has been stopped.
Bojian stated in the report: "The company made this decision in February 2021. It is based on the results of the research analysis as of December 31, 2020. We have confirmed the development agreement for the drug in the fourth quarter of 2020. The $75.4 million impairment charge has reduced the fair value of related intangible assets in the product development process (IPR&D) to zero. At the same time, we will apply the knowledge learned to future research on Parkinson’s disease."
Bojian added: “At present, the value of the contingent consideration debt related to the drug has been adjusted, which allows the company to show a profit of 51 million US dollars in the fourth quarter of 2020.”
Bojian cinemamab was obtained from the biotechnology company Neurimmune in 2016 and then entered the early research of Parkinson's disease. In 2018, Bojian outlined the design of the Phase 2 clinical study SPARK and stated that the study was the most advanced project in the company's Parkinson's disease drug pipeline at the time.
But with cinemanab being abandoned, Biogen will continue to shift its focus to its Alzheimer's disease drug aducanumab. The drug was jointly developed with Japan's Eisai company, and has been shrouded in huge controversy since its late-stage research. In late January this year, the US Food and Drug Administration (FDA) extended the aducanumab biological license application (BLA). ) Review period. The US FDA was originally expected to make a decision on the drug's marketing application on March 7, but this decision was recently postponed to June 7 to further weigh the data.