• The PADOVA study showed a numerical delay in motor progression and positive trends on several secondary and exploratory endpoints
• Prasinezumab continues to be well tolerated and no new safety signals were observed.
• Roche is currently evaluating the data and will work in collaboration with health authorities to determine next steps.

Basel, December 19, 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the Phase IIb PADOVA study evaluating prasinezumab in 586 people with early-stage Parkinson’s disease , treated for at least 18 months while they were on stable symptomatic treatment. treatment. Prasinezumab showed potential clinical efficacy on the primary endpoint of time to confirmation of motor progression, with HR = 0.84 (0.69-1.01) and p = 0 ,0657, without statistical significance. In a prespecified analysis, the effect of prasinezumab was more pronounced in the levodopa-treated population (75% of participants), HR=0.79 (0.63-0.99). Consistent positive trends across several secondary and exploratory endpoints were also observed. Prasinezumab continues to be well tolerated and no new safety signals were observed in the study.

“Parkinson’s disease is complex and devastating and no disease-modifying treatment options are available for the millions of people affected,” said Levi Garraway, MD, Ph.D., Roche’s chief medical officer and chief development officer. world of products. “We believe the consistent efficacy trends from the phase IIb study of prasinezumab merit further exploration. We will continue to work closely with the Parkinson’s community as we further evaluate the data to determine next steps.

The phase II PASADENA and phase IIb PADOVA open-label extension studies will continue to explore the effects observed in both studies. Roche will continue to evaluate the data and work collaboratively with health authorities to determine next steps.

The full results of the PADOVA study will be presented at an upcoming medical meeting.

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

Prasinezumab is currently being evaluated 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 (smaller score increase) in MDS-UPDRS Part?III scores at state. OFF (delayed start, -51%; early start, -65%) than the external comparator PPMI (n?=?303). The Prasinezumab Safety Database includes data from more than 900 Parkinson’s disease study participants who were treated with the investigational drug, including more than 500 who were treated over a period of 1, 5 to 5 years.

Roche entered into a licensing, development and commercialization agreement with Prothena in December 2013 to develop and commercialize monoclonal antibodies targeting a-syn, such as prasinezumab, for the treatment of Parkinson’s disease.

About the PADOVA study
PADOVA is a multicenter, randomized, double-blind, phase IIb trial evaluating the efficacy and safety of prasinezumab compared to placebo in 586 randomized patients with early-stage Parkinson’s disease on stable symptomatic treatment ( stable doses of levodopa or monoamine oxidase-B inhibitor). as monotherapy for more than three months initially). Patients receive monthly intravenous doses of prasinezumab 1,500 mg or placebo every four weeks for at least 76 weeks. This is followed by a two-year open-label extension phase during which all participants receive active treatment, which is currently ongoing.

The primary endpoint of PADOVA is the time to confirmation of motor progression of Parkinson’s disease (= 5-point increase in Parkinson’s Disease Rating Scale Part III score). Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) assessed in the OFF treatment condition). A 5-point increase in the MDS-UPDRS Part III represents a clinically significant motor progression event (Trundell et al., in press).

About Parkinson’s disease
Parkinson’s disease is a chronic, progressive, debilitating neurodegenerative disease characterized by the progressive loss of neurons that make dopamine and other nerve cells, as well as the development of motor and non-motor symptoms that may appear years before the onset. diagnosis. Today, Parkinson’s disease affects more than 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, having a significant impact on people’s quality of life; however, no available symptomatic treatment slows or stops the clinical progression of Parkinson’s disease and the effects fade over time as the disease progresses.

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

About Roche in Neuroscience
Neuroscience constitutes a major area of ​​research and development at Roche. Our goal is to pursue groundbreaking scientific research to develop new treatments that help improve the lives of people with potentially devastating chronic illnesses.

Roche is investigating more than a dozen drugs for the treatment of neurological disorders, including neuromuscular diseases: Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy, and spinal muscular atrophy; neuroimmune diseases: multiple sclerosis and neuromyelitis optica spectrum disorders; 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 to become 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 to improve and save the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform the way healthcare is delivered to make an even greater impact. To provide the best care for every person, we collaborate with many stakeholders and combine our strengths in diagnostics and pharmacy with data from clinical practice.

For more than 125 years, sustainability has been an integral part of Roche’s business. As a science-based 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 and Sustainable Markets Initiative to achieve carbon neutrality by 2045.

Genentech, in the United States, is a company 100% owned by the Roche group. Roche is the majority shareholder of Chugai Pharmaceutical in Japan.

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