Roche has announced results from the Phase IIb PADOVA study investigating prasinezumab in 586 individuals with early-stage Parkinson’s disease. Participants received treatment for a minimum of 18 months while maintaining stable symptomatic therapies. The study’s primary endpoint, time to confirmed motor progression, showed potential clinical efficacy with a hazard ratio (HR) of 0.84 [0.69-1.01] and a p-value of 0.0657. Although this missed statistical significance, a pre-specified analysis indicated a more pronounced effect among participants treated with levodopa (75% of the study population), achieving an HR of 0.79 [0.63-0.99]. Consistent positive trends were observed across several secondary and exploratory endpoints.
Prasinezumab was well tolerated throughout the study, with no new safety concerns identified. “Parkinson’s is a complex and devastating condition, and there are currently no disease-modifying treatment options available for the millions affected,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The consistent efficacy trends observed in this Phase IIb study of prasinezumab merit further exploration. We will continue working closely with the Parkinson’s community as we evaluate the data to determine the next steps.”
Roche plans to continue the Phase II PASADENA and Phase IIb PADOVA open-label extension studies to further investigate the observed effects in both trials. These extensions aim to provide additional insights into the long-term impact of prasinezumab treatment. Roche will analyze the results and collaborate with health authorities to decide on the next steps for prasinezumab’s clinical development.
Parkinson’s disease remains a significant unmet medical need, with over 10 million people worldwide affected by this progressive neurological disorder. The disease is characterized by motor symptoms such as tremors, rigidity, and bradykinesia, as well as non-motor symptoms that profoundly impact the quality of life. While current therapies focus on managing symptoms, there is a critical need for treatments that can slow or halt disease progression.
Prasinezumab is a monoclonal antibody designed to target alpha-synuclein, a protein implicated in the pathogenesis of Parkinson’s disease. Abnormal aggregation of alpha-synuclein in the brain is believed to play a central role in the development and progression of the disease. By targeting this protein, prasinezumab aims to address the underlying pathology of Parkinson’s, potentially modifying the disease course.
The PADOVA study’s findings build upon earlier data from the Phase II PASADENA trial, which also investigated prasinezumab in early-stage Parkinson’s. Although PASADENA did not meet its primary endpoint, it showed positive trends in some exploratory measures, providing a foundation for further research. The PADOVA study’s focus on motor progression and its detailed analyses, including the subgroup treated with levodopa, offer valuable insights for ongoing and future investigations.
Roche’s commitment to neurodegenerative diseases extends beyond Parkinson’s, with a pipeline of therapies targeting conditions such as Alzheimer’s disease, Huntington’s disease, and multiple sclerosis. The company’s work on prasinezumab underscores its dedication to developing innovative treatments that address significant unmet medical needs.
As the Phase IIb PADOVA open-label extension study progresses, Roche will continue to engage with the Parkinson’s community, including patients, caregivers, and healthcare providers. The goal is to ensure that research aligns with the needs and priorities of those affected by the disease. Additionally, Roche plans to share findings from the ongoing studies at scientific conferences and in peer-reviewed publications to contribute to the broader understanding of Parkinson’s disease and its treatment.
The consistent efficacy trends observed in the PADOVA trial offer hope for the potential of prasinezumab to provide meaningful benefits for individuals with early-stage Parkinson’s. While challenges remain in the pursuit of disease-modifying therapies, Roche’s dedication to advancing prasinezumab represents a significant step forward in addressing this urgent medical need. Further updates from Roche are anticipated as the company evaluates the data and determines the path forward for prasinezumab.
