- April 19, 2018
- Posted by: PharmaScroll
- Category:
As per a recent article published in Parkinson’s News Today, Biogen’s drug in Parkinson’s disease, BIIB054 was well-tolerated and had a favourable 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 Phase I trial was conducted with a primary objective to evaluate the safety, tolerability and pharmacokinetics of BIIB054, a human-derived monoclonal antibody that preferentially binds to aggregated forms of alpha-synuclein in patients with Parkinson’s disease (PD).
18 PD patients (age 47 – 75, 13 males, 5 females, H&Y≤2.5) were randomized to receive a single dose of 15, 45 mg/kg of BIIB054, or placebo, administered intravenously, and were evaluated over 16 weeks with clinical, neuroimaging, EKG and laboratory assessments. Serum and CSF concentrations of BIIB054 were measured, antibody-antigen complexes were measured in plasma.
Results of the study:
Serum half-life for BIIB054 in PD patients was approximately 30 days. Average CSF-to-serum ratio was 0.4%. Results of the healthy volunteer portion of this study have been previously reported. Overall, BIIB054 serum exposure and Cmax were dose proportional over the dose range studied. PK parameters for healthy volunteers and PD patients were similar. The presence of BIIB054-synuclein complexes in plasma was confirmed. Most adverse events were mild and most were assessed by the Investigators as unrelated to study drug.
The study concluded that preliminary results from the first study of BIIB054 in patients with PD shows a favorable PK, safety and tolerability profiles, providing rationale for further clinical development.
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News Source: https://parkinsonsnewstoday.com/2018/04/18/aan2018-biogen-biib054-posts-positive-data-parkinsons-trial/
Image Source: http://capitolweekly.net/n-ew-push-parkinsons-disease-stem-cell/