Swiss pharmaceuticals giant Roche today revealed its commitment to push forward prasinezumab, a lead candidate first-in-class antibody, into Phase III clinical trials for the treatment of early-stage Parkinson’s disease. The decision follows a promising body of data from the Phase IIb PADOVA study and its extended follow-up, indicating the drug may have clinical benefits on top of current symptomatic therapy.
Prasinezumab, a developing monoclonal antibody, targets and binds aggregated alpha-synuclein, a protein that is thought to be a major driver of Parkinson’s disease progression. By aiming at this underlying biological process, the treatment potentially lowers the toxicity to neurons and slows the decline of the disease.
We are encouraged by the efficacy signals observed across the two phase II trials and their open-label extensions, combined with the favourable safety and tolerability profile of prasinezumab,
We also recognise the substantial need for new treatment options, and the totality of data suggest that prasinezumab may have the potential to become the first disease-modifying treatment for people with Parkinson’s disease.
Levi Garraway
Although the main outcome of the PADOVA study, the time to confirmed motor progression, did not reach statistical significance, Roche highlighted several endpoints on both the PADOVA study and its open-label extension (OLE) that indicate a possible clinical benefit for early Parkinson’s patients. These continuous studies, PASADENA and PADOVA OLE, are now assessing the long-term safety and effectiveness of prasinezumab in a group of more than 750 participants.
This achievement highlights Roche’s dedication to addressing challenging neurological diseases. Roche is actively exploring various therapeutic strategies to stop or slow disease progression in Parkinson’s by targeting important pathological mechanisms, such as the aggregation of alpha-synuclein, lysosomal impairment, and neuroinflammation.
In addition to Parkinson’s, Roche’s neuroscience pipeline holds over a dozen experimental drugs for various conditions like Alzheimer’s disease, multiple sclerosis, spinal muscular atrophy, Duchenne muscular dystrophy, neuromyelitis optica spectrum disorder, and Huntington’s disease. Advancement of prasinezumab to the last stage of clinical trials represents an important milestone in the continuous quest for a disease-modifying treatment for patients with Parkinson’s.
An experimental monoclonal antibody called praminezumab is intended to bind aggregated alpha-synuclein and lessen neuronal damage. Prasinezumab may be able to stop additional accumulation and cell-to-cell transmission of alpha-synuclein protein by decreasing its buildup in the brain, which could halt the disease’s progression.
Prasinezumab is still well tolerated, and the study found no new safety warning signs. Data from nearly 900 Parkinson’s disease trial participants who received prasinezumab treatment are included in the safety database. Of them, over 750 are still receiving open label treatment, and over 500 have received treatment for 1.5–5 years.
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