Roche Propels Alzheimer’s Treatment Forward with Rapid Amyloid Clearance and Breakthrough Diagnostic Test

Roche Propels Alzheimer’s Treatment Forward with Rapid Amyloid Clearance and Breakthrough Diagnostic Test

(IN BRIEF) Roche presented new data at the AD/PD 2025 International Conference demonstrating that trontinemab, in its Phase Ib/IIa Brainshuttle™ AD study, achieves rapid and dose-dependent reductions of amyloid plaques in the brain, with significant biomarker improvements observed in fluid samples. The study revealed that a high percentage of participants receiving the higher dose achieved amyloid levels below the positivity threshold within 28 weeks. Complementing these findings, a large multicentre study of the Elecsys® pTau181 plasma test showed its potential in accurately ruling out amyloid pathology in individuals with cognitive impairment, thereby streamlining the diagnostic process. Building on this comprehensive dataset, Roche announced plans to initiate a Phase III programme for trontinemab later this year, as part of its broader effort to enhance Alzheimer’s diagnostics and treatment strategies.

(PRESS RELEASE) BASEL, 4-Apr-2025 — /EuropaWire/ — At the AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases in Vienna, Austria, Roche presented compelling new data reinforcing the efficacy of trontinemab in rapidly and significantly lowering amyloid plaques in the brain. The Phase Ib/IIa Brainshuttle™ AD study demonstrated that trontinemab produces a swift, deep, and dose-dependent reduction in amyloid levels, with 81% of participants in the 3.6 mg/kg cohort falling below the 24 centiloid threshold after 28 weeks. These findings are bolstered by early reductions in key fluid biomarkers, including total tau, phosphorylated Tau (pTau)181, pTau217, and neurogranin in both cerebrospinal fluid and plasma. The safety profile of trontinemab remains favorable, with less than 5% of participants experiencing mild amyloid-related imaging abnormalities (ARIA-E).

In parallel, Roche showcased results from a multicentre study involving 604 participants for its Elecsys® pTau181 plasma test. This minimally invasive blood test has shown promise in accurately ruling out amyloid pathology—one of the central hallmarks of Alzheimer’s disease—in individuals with cognitive impairment. By effectively excluding those without amyloid accumulation, the test may reduce the need for more invasive, costly, and time-consuming procedures such as cerebrospinal fluid analysis or PET scans. Roche expects the Elecsys® pTau181 test to be available in Europe by late 2025, with subsequent availability in the U.S.

Furthermore, based on the robust dataset from the ongoing Brainshuttle™ AD study, Roche announced its plans to launch a Phase III programme for trontinemab later this year. “We are pleased with the progress across our Alzheimer’s portfolio as we move ahead with a Phase III trontinemab programme and continue to expand our diagnostic solutions,” stated Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. He emphasized the urgent need for more accurate and less invasive diagnostic tools and effective disease-modifying treatments, given that over 55 million people worldwide live with dementia, with approximately 70% of cases attributed to Alzheimer’s disease.

About Roche in Neurology
Neurology is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new diagnostic solutions and treatments that help improve the lives of people with chronic and potentially devastating diseases. Roche is committed to using its diagnostic and pharmaceutical capabilities in an effort to better detect and treat neurological diseases as early as possible, and working toward preventing them altogether.

Roche is investigating more than a dozen medicines for neurological disorders, including Alzheimer’s disease, multiple sclerosis, spinal muscular atrophy, Duchenne muscular dystrophy, Parkinson’s disease, neuromyelitis optica spectrum disorder and Huntington’s disease. Roche diagnostics offers one of the broadest portfolio of solutions, including approved and investigational tools, such as digital and blood-based tests and CSF assays, aiming to more effectively detect, diagnose and monitor the disease. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today.

About trontinemab
Trontinemab is an investigational Brainshuttle™ bispecific 2+1 amyloid-beta antibody specifically engineered for enhanced access to the brain to enable rapid reduction of amyloid in people with Alzheimer’s disease. Trontinemab is designed for the efficient transport across the blood-brain barrier to target aggregated forms of amyloid beta and remove amyloid plaques in the brain.

The uniqueness of trontinemab is based on Roche’s proprietary Brainshuttle technology combining an amyloid beta-binding monoclonal antibody with a transferring receptor (TfR1) shuttle module. As a result, high central nervous system (CNS) exposure of trontinemab may be achieved at low doses, leading to a rapid and deep amyloid clearance. Due to its unique properties, trontinemab might unlock the full potential of disease-modifying monoclonal antibodies by effectively penetrating the brain and potentially leading to slowing of disease progression.

About prasinezumab
Prasinezumab is an investigational monoclonal antibody designed to selectively bind aggregated alpha-synuclein (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. 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 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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SOURCE: ROCHE