Roche Prothena Plan To Advance Prasinezumab Into Phase 2b Study To Treat Parkinson’s Disease

Prothena Corporation, a late-stage clinical company, announced that based on positive signals of efficacy consistent with disease modification in the PASADENA study, Roche and Prothena plan to advance prasinezumab into a phase 2b study in patients with early Parkinson’s disease. The study will be designed to further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA to include patients with early Parkinson’s disease on stable levodopa therapy. Prasinezumab is the first anti-alpha synuclein antibody to advance into late-stage development. Prothena will earn a US$ 60 million clinical milestone payment upon first patient dosed in this study. Further details are expected to be announced in the first half of 2021.“We are very encouraged by the results from PASADENA, demonstrating significant slowing of motor progression and improvements on imaging biomarkers consistent with disease modification, as this provides a rich dataset to directly inform and de-risk this next late-stage study,” stated Gene Kinney, PhD, president and chief executive officer of Prothena. “Results from the PASADENA study are part of a growing clinical body of evidence suggesting antibodies that optimally target misfolded proteins can result in clinically meaningful benefit. With a growing pipeline of programs based on this scientific approach, Prothena is poised to advance a number of novel therapeutics for devastating diseases.”Parkinson's disease is a progressive degenerative disorder of the entire nervous system that affects one in 100 people over age 60. An estimated seven to 10 million people are living with Parkinson's disease worldwide. It is the second most common neurodegenerative disorder after Alzheimer's disease.Alpha-synuclein, a protein found in neurons and other cells, is a major component of pathology that characterizes several neurodegenerative disorders including Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy, which collectively are termed synucleinopathies. The understanding of the normal physiological function of alpha-synuclein is limited, but evidence indicates that soluble forms of the protein may interact with other proteins and certain intracellular membranes. In synucleinopathies, the alpha-synuclein protein appears to be abnormally aggregated intracellularly, which contributes to disease pathology. There is increasing evidence that certain aggregated forms of alpha-synuclein can be transmitted from neuron to neuron, resulting in a propagation of pathology that causes neuronal dysfunction and loss.Prasinezumab is a humanized monoclonal antibody that targets alpha-synuclein, a protein found in neurons that can aggregate and spread from cell to cell, resulting in the neuronal dysfunction and loss that causes Parkinson’s disease. Prasinezumab is designed to block the cell-to-cell transmission of the aggregated, pathogenic forms of alpha-synuclein in Parkinson's disease, thereby slowing clinical decline. Prior to initiating clinical trials, the efficacy of prasinezumab was evaluated in various cellular and animal models of alpha-synuclein-related disease. In alpha-synuclein transgenic mice, the murine version of prasinezumab reduced the appearance of alpha-synuclein pathology, protected synapses and halted the worsening of behavioral phenotypes.

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