Roche Shares Promising Phase IIb PADOVA Study Results for Prasinezumab in Early-Stage Parkinson’s Disease

December 20, 2024

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Roche Shares Promising Phase IIb PADOVA Study Results for Prasinezumab in Early-Stage Parkinson’s Disease

(IN BRIEF) Roche has announced results from the Phase IIb PADOVA study evaluating prasinezumab in 586 individuals with early-stage Parkinson’s disease. While the primary endpoint of time to confirmed motor progression narrowly missed statistical significance, promising efficacy trends were observed, particularly among participants receiving levodopa. The treatment showed positive results across secondary and exploratory endpoints and maintained a favorable safety profile. Roche will continue exploring prasinezumab’s potential through open-label extension studies and collaboration with health authorities. Prasinezumab targets aggregated α-synuclein to slow disease progression and is being developed in partnership with Prothena. Full PADOVA results will be presented at an upcoming medical meeting.

(PRESS RELEASE) BASEL, 20-Dec-2024 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced new findings from the Phase IIb PADOVA study, which assessed prasinezumab in 586 individuals with early-stage Parkinson’s disease. Participants received the treatment for at least 18 months alongside stable symptomatic therapy. While the primary endpoint of time to confirmed motor progression narrowly missed statistical significance (HR=0.84 [0.69-1.01], p=0.0657), prasinezumab showed greater potential efficacy in participants receiving levodopa (75% of the cohort), with a hazard ratio of HR=0.79 [0.63-0.99].

Additionally, consistent positive trends were observed across several secondary and exploratory endpoints. The investigational monoclonal antibody continues to demonstrate a favorable safety profile, with no new safety signals reported.

A Complex Disease in Need of Innovation

“Parkinson’s disease is a devastating condition with no available disease-modifying treatments,” 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 justify further exploration of prasinezumab. We are committed to working closely with the Parkinson’s community as we evaluate the data and determine next steps.”

Next Steps and Ongoing Studies

Roche plans to continue the open-label extensions of the PADOVA and PASADENA Phase II studies, which aim to further explore prasinezumab’s effects. Results from the PADOVA study will be presented at an upcoming medical conference. Meanwhile, Roche will collaborate with health authorities to chart the future development of the treatment.

About Prasinezumab

Prasinezumab is an investigational monoclonal antibody that selectively targets aggregated α-synuclein (α-syn) proteins in the brain. By preventing the accumulation and cell-to-cell spread of these aggregates, prasinezumab aims to slow the progression of Parkinson’s disease.

The drug is supported by robust scientific evidence, with data from more than 900 study participants, including over 500 treated for 1.5 to 5 years. Recent findings from the PASADENA study, published in Nature Medicine (October 2024), showed a slower decline in motor progression compared to a matched cohort from the PPMI natural history study.

Prasinezumab is being developed through a collaboration between Roche and Prothena, established in 2013, to develop and commercialize monoclonal antibodies targeting α-synuclein for Parkinson’s treatment.

About prasinezumab
Prasinezumab is an investigational monoclonal antibody designed to selectively bind aggregated α-syn and reduce neuronal toxicity. By targeting the build-up of α-syn protein in the brain, prasinezumab can potentially prevent further accumulation and spreading between cells, thereby slowing down the progression of the disease. The evidence supporting targeting α-syn aggregates as a mechanism of action in Parkinson’s disease is based on a wide range of scientific evidence in the field.

Prasinezumab is currently being assessed in ongoing open-label extensions of the Phase II PASADENA and Phase IIb PADOVA studies. Four-year data from the PASADENA study showed potential evidence of sustained slowing of motor progression compared to a matched PPMI natural history study cohort, published in the October 2024 edition of Nature Medicine. The PASADENA delayed-start (n = 94) and early-start (n = 177) groups showed a slower decline (a smaller increase in score) in MDS–UPDRS Part III scores in the OFF state (delayed start, −51%; early start, −65%) than did the PPMI external comparator (n = 303). The safety database for prasinezumab consists of data from more than 900 Parkinson’s disease study participants that have been treated with the investigational medicine, including more than 500 who were treated over 1.5-5 years.

Roche entered into a Licensing, Development, and Commercialisation agreement with Prothena in December 2013 to develop and commercialise monoclonal antibodies targeting α-syn, such as prasinezumab, for the treatment of Parkinson’s disease.

About the PADOVA study
PADOVA is a Phase IIb multicentre, randomised, double-blind trial evaluating the efficacy and safety of prasinezumab compared with placebo in 586 randomised patients with early-stage Parkinson’s disease who were on stable symptomatic treatment (stable doses of levodopa or monoamine oxidase-B inhibitor as monotherapy for more than three months at baseline). Patients receive monthly intravenous doses of prasinezumab 1500 mg or placebo every four weeks for at least 76 weeks. This is followed by a two-year open-label extension phase in which all participants receive active treatment, which is currently ongoing.

The primary endpoint of PADOVA is the time to confirmed motor progression of Parkinson’s disease (≥5-point increase in Movement Disorder Society-Unified Parkinson’s Disease Rating Scale [MDS-UPDRS] Part III score assessed in OFF medication state). A 5-point increase in MDS-UPDRS Part III represents a clinically meaningful motor progression event (Trundell et al., in press).

About Parkinson’s disease
Parkinson’s disease is a chronic, progressive and debilitating neurodegenerative disease characterised by the gradual loss of neurons that make dopamine and other nerve cells, and the development of motor and non-motor symptoms that may appear years before diagnosis. Today, PD affects over 10 million people worldwide. The prevalence of Parkinson’s disease is increasing, and it has become one of the fastest-growing neurological disorders. Currently, symptomatic treatments that effectively alleviate motor symptoms are available today, having a significant impact on people’s quality of life; however, no available symptomatic therapies slow down or stop the clinical progression of Parkinson’s disease and the effects wear off over time as the disease progresses.

Roche is evaluating multiple approaches to slow down disease progression and potentially prevent Parkinson’s disease that involve targeting underlying disease processes such as aggregated α-syn production, lysosomal dysfunction and neuroinflammation.

About Roche in Neuroscience
Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Roche is investigating more than a dozen medicines for neurological disorders, including neuromuscular diseases: Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy and spinal muscular atrophy; neuro immune diseases: multiple sclerosis and neuromyelitis optica spectrum disorder; and neurodegenerative diseases: Alzheimer’s disease, Parkinson’s disease and Huntington’s disease. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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