Due to negative clinical trial findings, Biogen has discontinued the development of cinpanemab (BIIB054), an investigational medication intended to treat Parkinson’s disease, the company announced in its 2020 investors report.
Cinpanemab is a human-derived antibody that targets alpha-synuclein, thought to be one of the key hallmarks of Parkinson’s disease. In the brains of people with Parkinson’s disease, there often are protein clumps predominantly composed of alpha-synuclein; these clumps, typically referred to as “aggregates,” are thought to drive disease progression.
By targeting these protein clumps, researchers had hoped cinpanemab would stop the spread of protein aggregates in the brain, thus slowing disease progression.
An early Phase 1 placebo-controlled clinical trial (NCT02459886) assessed the safety profile of the investigational medication in 16 participants with Parkinson’s disease. Results were positive; most reported adverse side effects were mild and unrelated to treatment with cinpanemab. The medication also showed a promising pharmacokinetic profile, (Pharmacokinetics refers to how a medication moves through and is processed by the body.)
SPARK enrolled 357 people with Parkinson’s, who were assigned randomly to receive either cinpanemab or a placebo, administered by intravenous (into-the-bloodstream) infusion every four weeks. Three different doses of the investigational medication were tested: 250 mg, 1,250 mg, and 3,500 mg.
The study’s primary goal was the change from the start of the study in total scores on the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) after 52 and 72 weeks of treatment. The MDS-UPDRS is a four-part scale that measures impairment and disability in people with Parkinson’s.
Secondary goals of the study included changes in the individual components of MDS-UPDRS, as well as comparisons among MDS-UPDRS scores at different time points. Safety and pharmacokinetics also were assessed, as was the impact of treatment on dopamine activity in the brains of participants.
In its investors report, Biogen announced that the Phase 2 SPARK study “did not meet its primary or secondary endpoints.”
As such, the company recently made the decision to discontinue the development of cinpanemab for Parkinson’s. Biogen noted that, while the decision was ultimately made in February, the decision “was based on conditions that existed as of December 31, 2020.”
Associated with the decision, Biogen announced an impairment charge (a sudden large drop in the value of an asset) of approximately $75 million.
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