#AAN2018: Biogen’s BIIB054 Shows Positive Data in Phase 1 Parkinson’s Trial

#AAN2018: Biogen’s BIIB054 Shows Positive Data in Phase 1 Parkinson’s Trial

Parkinson’s treatment candidate BIIB054 was well-tolerated and had a favorable pharmacological profile in preliminary Phase 1 clinical results.

Biogen will present those results at the 2018 American Academy of Neurology ANN Annual Meeting in Los Angeles, California, April 21-27. Parkinson’s News Today will be covering the conference.

The presentation “Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of AntiAlpha-Synuclein Antibody BIIB054 in Patients with Parkinson’s Disease,” will be made at 3:30 p.m.  PST April 24.

People with Parkinson’s disease often exhibit clumps mainly composed of the aggregated form of a protein called alpha-synuclein. These clumps result from incorrect folding of alpha-synuclein into its 3-D structure and severely impair nerve cell communication. Scientists believe that alpha-synuclein aggregates spread from diseased to healthy cells, dictating Parkinson’s progression.

BIIB054 is a human-derived antibody that binds to aggregated alpha-synuclein, preventing the clumped protein from spreading.

Biogen conducted a placebo-controlled Phase 1 trial (NCT02459886) to evaluate the safety, tolerability and pharmacokinetics of a range of intravenous, single BIIB054 doses, in healthy participants and patients with early Parkinson’s disease. Pharmacokinetics refers to a drug’s absorption, bioavailability, distribution, metabolism, and excretion in the body.

Scientists also analyzed BIIB054’s pharmacokinetics in participants’ blood, along with the investigational compound’s immunogenicity, or its ability to induce an immune response in the body.

A total of 18 Parkinson’s patients (aged 47-75, 13 men) randomly received a range of single doses of BIIB054 (15-45 mg/kg) or placebo. Subjects were evaluated for 16 weeks with clinical, brain imaging, electrocardiogram (measuring the heart’s electrical activity), and laboratory assessments.

BIIB054’s blood half-life — the time required for a 50 percent reduction in the amount of a compound —  was approximately 30 days in Parkinson’s patients. The average amount of BIIB054 in the cerebrospinal fluid, which fills the brain and spinal cord, was 0.4% relative to that of the blood.

PK data of healthy volunteers and Parkinson’s patients were similar. BIIB054-synuclein complexes were found in the blood, confirming the molecule’s binding to alpha-synuclein.

Most adverse events were mild and unrelated to treatment with BIIB054.

“Preliminary results from the first study of BIIB054 in patients with [Parkinson’s] shows a favorable [pharmacokinetics], safety and tolerability profiles, providing rationale for further clinical development,” researchers wrote.

José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has studied Biochemistry also at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario, in London, Ontario. His work ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
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José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has studied Biochemistry also at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario, in London, Ontario. His work ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
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