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Prasinezumab
Experimental monoclonal antibody From Wikipedia, the free encyclopedia
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Prasinezumab (INN, USAN; developmental code names NEOD002, PRX-002, RG-7935, RO-7046015) is an anti-α-synuclein drug acting as a monoclonal antibody against α-synuclein which is under development for the treatment of Parkinson's disease.[1][2][3][4] No significant effect on disease progression was seen in a 52-week phase 2 clinical trial.[5]There have been concerns about research misconduct and data fabrication relevant to prasinezumab.[6] [2]
As of May 2024, prasinezumab is in phase 3 clinical trials for Parkinson's disease.[1][7] It is under development by Prothena Biosciences and Roche.[1]
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Mechanism of action
Prasinezumab is a humanized IgG1 monoclonal antibody that selectively binds to aggregated forms of alpha-synuclein while sparing the physiological monomeric form. The antibody recognizes the C-terminus of α-synuclein and preferentially targets pathological aggregates that form insoluble fibrils and Lewy bodies—hallmark features of Parkinson's disease pathology.[8][9][10]
Development history
Prasinezumab was originally developed under the designation PRX002 through a collaboration between Hoffmann-La Roche and Prothena. The drug entered clinical development as a potential disease-modifying therapy for Parkinson's disease, representing one of the first attempts to target aggregated α-synuclein therapeutically.[11]
Clinical trials
PASADENA Trial
The Phase II PASADENA trial was a randomized, double-blind, placebo-controlled study that evaluated prasinezumab in participants with early-stage Parkinson's disease. Participants were randomly assigned to receive either placebo or prasinezumab at doses of 1500 mg or 4500 mg intravenously every 4 weeks for 52 weeks.[12][13]
While the trial did not meet its primary endpoint (change in Movement Disorder Society Unified Parkinson's Disease Rating Scale [MDS-UPDRS] sum of Parts I + II + III from baseline to week 52), exploratory analyses revealed promising signals:[14][15]
- Prasinezumab-treated participants showed slower progression of motor signs compared to placebo (MDS-UPDRS Part III)
- The effect was more pronounced in participants with rapidly progressing disease
- Benefits appeared to be sustained over the 4-year open-label extension period
PADOVA Trial
The Phase IIb PADOVA trial further evaluated prasinezumab's efficacy and safety profile. While the primary endpoint of time to confirmed motor progression did not achieve statistical significance (HR=0.84, p=0.0657), the results suggested potential clinical benefit, particularly in pre-specified subgroups.[16][17]
Recent Developments
Based on encouraging results from Phase II studies, Genentech announced in June 2025 its decision to advance prasinezumab into Phase III clinical development for early-stage Parkinson's disease. This represents a significant milestone in the development of α-synuclein-targeting therapies.[18]
As of 2025, prasinezumab development includes:[18]
- Phase III development initiated for early-stage Parkinson's disease
- Continued evaluation in open-label extension studies
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See also
References
External links
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