{"id":61645,"date":"2025-07-28T07:04:33","date_gmt":"2025-07-28T05:04:33","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/genentech-and-roche-present-new-insights-in-alzheimers-disease-research-across-its-diagnostics-and-pharmaceutical-portfolios-at-aaic\/"},"modified":"2025-07-28T07:04:33","modified_gmt":"2025-07-28T05:04:33","slug":"genentech-and-roche-present-new-insights-in-alzheimers-disease-research-across-its-diagnostics-and-pharmaceutical-portfolios-at-aaic","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/genentech-and-roche-present-new-insights-in-alzheimers-disease-research-across-its-diagnostics-and-pharmaceutical-portfolios-at-aaic\/","title":{"rendered":"Genentech and Roche Present New Insights in Alzheimer\u2019s Disease Research Across Its Diagnostics and Pharmaceutical Portfolios at AAIC"},"content":{"rendered":"
\n

\n\u2013 Trontinemab\u2019s Phase Ib\/IIa Brainshuttle\u2122 AD study continues to show rapid and robust clearance of amyloid plaques, with 91% becoming amyloid PET negative and ARIA-E remaining <5% \u2013<\/i><\/p>\n

\n\u2013 Design of the Phase III TRONTIER 1 and 2 studies of trontinemab in early symptomatic Alzheimer\u2019s disease featured, with initiation planned in 2025 \u2013<\/i><\/p>\n

\n\u2013 Plans for new Phase III trial investigating trontinemab in preclinical Alzheimer\u2019s disease, in people at high risk of cognitive decline \u2013<\/i><\/p>\n

\n\u2013 New real-world data support Elecsys pTau217 as a standalone blood test, comparable to a PET scan, for rule-in and rule-out identification of amyloid pathology \u2013<\/i><\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data from its Alzheimer\u2019s development portfolio is being presented at the Alzheimer\u2019s Association International Conference (AAIC) in Toronto, Canada (July 27-30). These data exemplify the comprehensive approach Roche is taking in addressing Alzheimer\u2019s across the entire patient journey.<\/p>\n

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<\/a><\/p>\n

\nFeatured oral presentations include the latest results from the ongoing Phase Ib\/IIa Brainshuttle\u2122 AD study, which continue to support rapid and robust reduction of amyloid plaques, and design of the Phase III TRONTIER 1 and 2 studies of investigational trontinemab for early symptomatic Alzheimer\u2019s disease, with initiation planned later this year. As part of its growing Alzheimer\u2019s development program, Roche announced today its plans for an additional Phase III trial to investigate trontinemab in preclinical Alzheimer\u2019s disease. The trial will focus on individuals at risk of cognitive decline, with the goal of potentially delaying or preventing the progression of the disease to symptomatic stages.<\/p>\n

\n\u201cAlzheimer\u2019s disease represents one of the greatest challenges in healthcare today and tackling it requires early detection and effective therapeutics,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cTrontinemab is designed to target a key driver of Alzheimer\u2019s disease biology more effectively in the brain. Combining new treatment avenues with advanced diagnostics may enable earlier and potentially more effective intervention. With plans for Phase III trials in both early symptomatic and preclinical Alzheimer\u2019s disease, we are advancing science with the goal of delaying\u2014and ultimately preventing\u2014progression of this devastating condition.\u201d<\/p>\n

\nLate-breaking oral and poster presentations highlight the potential of Roche\u2019s Elecsys\u00ae<\/sup> pTau217 as a reliable and accessible blood-based biomarker test, providing comparable results to PET scan and cerebrospinal fluid (CSF) diagnostics for rule-in and rule-out diagnosis of amyloid pathology, a hallmark of Alzheimer\u2019s disease, across care settings. The test, which received Breakthrough Device Designation from the U.S. Food and Drug Administration last year, will also be utilized in Roche\u2019s TRONTIER studies.<\/p>\n

\n\u201cBlood based testing for Alzheimer\u2019s disease has the potential to greatly improve patient access and decrease the time to definitive disease diagnosis,\u201d said Matt Sause, CEO of Roche Diagnostics. \u201cOur data show that the Elecsys pTau217 test performs comparably to PET scans but can be performed with a simple blood draw and analyzed in a routine clinical laboratory. This has the potential to transform the diagnosis of Alzheimer’s and provide clear answers to caregivers, patients, and their families.\u201d<\/p>\n

\nUp to 75% of people living with symptoms of Alzheimer\u2019s disease globally have not been diagnosed, and those who have, waited an average of 2.8 years, and even less have received any form of treatment. Diagnostics play a crucial role in addressing the global challenge of Alzheimer\u2019s, not only to detect and identify people with the disease early, even before the first symptoms, but also to rule out those who may or may not benefit from specific treatments.<\/p>\n

\nPharmaceuticals<\/b><\/p>\n

\nIn a 90-minute Featured Research session, designs were shared for the Phase III studies, TRONTIER 1 and 2, which will initiate later this year, investigating the efficacy and safety of investigational trontinemab in people with early Alzheimer\u2019s disease. The primary endpoint will measure the change in cognition and function based on the Clinical Dementia Rating \u2013 Sum of Boxes scale after 18 months of treatment. Secondary endpoints will include assessments of cognition, function, behavioral symptoms, and quality of life. A pre-screening study, TRAVELLER, based on a brief clinical assessment and a plasma biomarker, which will be identified using the Elecsys pTau217 test, has also been initiated, to enable broader community outreach and extend access to these trials to more diverse populations representative of Alzheimer\u2019s disease.<\/p>\n

\nNew data on the latest results for trontinemab from the completed dose-expansion part of the 1.8 mg\/kg and 3.6 mg\/kg cohorts from the ongoing Phase Ib\/IIa Brainshuttle AD study continued to show rapid and robust reduction of amyloid plaques in the brain as measured by amyloid positron emission tomography (PET). In the 3.6 mg\/kg cohort, trontinemab reduced amyloid levels below the 24 centiloid positivity threshold in 91% of participants (n=49\/54) after 28 weeks of treatment; 72% (n=39\/54) achieved deep clearance below 11 centiloids.<\/p>\n

\nThese data were reinforced by early and significant reductions in fluid biomarkers of Alzheimer\u2019s disease, including total tau, phosphorylated Tau (pTau)181, pTau217, and neurogranin measured in CSF and plasma.Trontinemab continues to show a favourable safety and tolerability profile. Amyloid-related imaging abnormalities-edema\/effusion (ARIA-E) continued to be observed in <5% of participants (blinded data; N=4\/149 across 1.8 and 3.6 mg\/kg dose cohorts). All cases were radiographically mild, one was associated with mild and transient symptoms.<\/p>\n

\nDiagnostics<\/b><\/p>\n

\nRoche will present data on a new study comparing the pTau217\/Ab42 plasma ratio to the high-throughput, fully automated Elecsys pTau217 assay. The presentation will report on the accuracy of these tools in detecting amyloid pathology. Together with the high throughput and full automation of the assay, these data will assess the potential of Elecsys pTau217 as an accurate standalone rule-in and rule-out test that could be scaled up for broad implementation in routine clinical practice worldwide.<\/p>\n

\nAdditionally, results from a cohort-based model of healthcare utilization in the U.S. demonstrated that using the Elecsys\u00ae<\/sup> pTau181 blood-based rule-out test in primary care scenarios improved diagnostic accuracy and reduced resource use compared with the current standard-of-care clinical, cognitive and imaging tests. If made available in primary care settings, the Roche Elecsys\u00ae<\/sup> pTau181 blood test has the potential to reliably avoid the need for further confirmatory testing in nearly all people who receive a negative result. This will avoid the need for these people to undergo unnecessary testing using CSF or PET, which often come with long wait times and high cost, resulting in further delays to diagnosis and cost to healthcare systems.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\nMedicine<\/p>\n<\/td>\n

\n

\nAbstract title<\/p>\n<\/td>\n

\n

\nPresentation number (type)<\/p>\n

\nPresentation date (session)<\/p>\n

\nTime<\/p>\n<\/td>\n<\/tr>\n

\n

\nAbstracts will be available on the AAIC website.<\/p>\n<\/td>\n<\/tr>\n

\n

\nPharmaceuticals<\/p>\n<\/td>\n

\n

\nNext wave of innovation in Alzheimer\u2019s disease therapeutics: The value of novel active transport mechanisms<\/p>\n<\/td>\n

\n

\nFeatured Research Session (FRS), Talk 1<\/p>\n

\nRoom 718<\/p>\n

\n27 July 2025, 2pm – 3:30pm EDT<\/p>\n

\nCath Mummery, Roberto Villase\u00f1or, Jens Niewoehner, Scarlett Barker, Luka Kulic<\/p>\n<\/td>\n<\/tr>\n

\n

\nLatest results from the dose-expansion part (Part 2) of the Brainshuttle\u2122 AD study of trontinemab in people with Alzheimer\u2019s disease<\/p>\n<\/td>\n

\n

\nFeatured Research Session (FRS), Talk 2<\/p>\n

\nRoom 718<\/p>\n

\n27 July 2025, 2pm – 3:30pm EDT<\/p>\n

\nLuka Kulic, Fabien Alcaraz, Gregory Klein, Stephen Salloway, Carsten Hofmann, Jo\u00e3o A. Abrantes, Stella Yilmaz, Denise Sickert, Maddalena Marchesi, Jakub Wojtowicz, Andres Schneider, Ruth Croney, David Agnew, Silke Ahlers, Paul Delmar, Hanno Svoboda, Iris Wiesel<\/p>\n<\/td>\n<\/tr>\n

\n

\nInterim biomarker results for trontinemab, a novel Brainshuttle\u2122 antibody in development for the treatment of Alzheimer\u2019s disease<\/p>\n<\/td>\n

\n

\nFeatured Research Session (FRS), Talk 3<\/p>\n

\nRoom 718<\/p>\n

\n27 July 2025, 2pm – 3:30pm EDT<\/p>\n

\nGregory Klein, Gil Rabinovici, Henrik Zetterberg, Matteo Tonietto, Tobias Bittner, Daria Rukina, Fabien Alcaraz, Carsten Hofmann, Maddalena Marchesi, Jakub Wojtowicz, Ruth Croney, David Agnew, Jo\u00e3o A. Abrantes, Franziska Schaedeli Stark, Silke Ahlers, Paul Delmar, Hanno Svoboda, Iris Wiesel, Luka Kulic<\/p>\n<\/td>\n<\/tr>\n

\n

\nTRONTIER 1 and TRONTIER 2: Pivotal trials of trontinemab in early symptomatic Alzheimer\u2019s disease<\/p>\n<\/td>\n

\n

\nFeatured Research Session (FRS), Talk 4<\/p>\n

\nRoom 718<\/p>\n

\n27 July 2025, 2pm – 3:30pm EDT<\/p>\n

\nJanice Smith, Catherine Mummery, Jeffrey L. Cummings, Gil Rabinovici, Stephen Salloway, Reisa Sperling, Henrik Zetterberg, Angeliki Thanasopolou, Christopher Lane, Paul Delmar, Gregory Klein, Ruth Croney, Jakub Wojtowicz, Carsten Hofmann, Luka Kulic, Hideki Garren<\/p>\n<\/td>\n<\/tr>\n

\n

\nDiagnostics<\/p>\n<\/td>\n

\n

\nEvaluating the Impact on Diagnostic Performance and Healthcare Resource Utilization of Introducing a plasma rule-out test in the Alzheimer’s Disease Diagnostic Pathway<\/p>\n<\/td>\n

\n

\nPoster #102729<\/p>\n

\n27 July 2025, 7:30am – 4:15pm EDT<\/p>\n

\nSophie Roth<\/span>, Gustaf Orts\u00e4ter, Joana Amorim Freire<\/p>\n

\nLocation tbc<\/p>\n

\n\u00a0<\/p>\n<\/td>\n<\/tr>\n

\n

\nEvaluating the Clinical Performance of the Elecsys pTau217 Plasma Immunoassay to Detect Amyloid Pathology in a Routine Clinical Practice Cohort<\/p>\n<\/td>\n

\n

\nPoster #96679<\/p>\n

\n28 July 2025, 7:30am \u2013 4:15pm EDT<\/p>\n

\nSayuri Hortsch<\/span>, Niels Borlinghaus, Alexander Jethwa, David Caley, Annunziata Di Domenico, Craig Ritchie<\/p>\n

\n\u00a0<\/p>\n<\/td>\n<\/tr>\n

\n

\nClinical performance and effect of pre-analytical variation of plasma pTau217 alone versus the plasma pTau217\/A\u03b242 ratio for the identification of amyloid pathology<\/p>\n<\/td>\n

\n

\nOral Developing Topics #108585<\/p>\n

\n3-23-DEV Developing Topics on Tau Biomarkers<\/p>\n

\n29 July 2025, 2:00pm \u2013 3:30pm EDT<\/p>\n

\nChristopher M. Rank, Joana Amorim Freire, Alexander Jethwa, Annunziata Di Domenico, Christina Rabe, Marc Su\u00e1rez-Calvet<\/span>, Colin L. Masters, Tobias Bittner<\/p>\n

\n\u00a0<\/p>\n<\/td>\n<\/tr>\n

\n

\nAccuracy of cerebrospinal fluid biomarker ratios to determine amyloid positron-emission tomography status: a diagnostic test accuracy meta-analysis<\/p>\n<\/td>\n

\n

\nPoster #100941<\/p>\n

\n28 July 2025, 7:30am \u2013 4:15pm EDT<\/p>\n

\nPablo Martinez-Lage, Eino Solje, Julian G. Martins, Sraboni Sarkar<\/p>\n

\n\u00a0<\/p>\n<\/td>\n<\/tr>\n

\n

\nEquity in diagnosis through adequate clinical trial design in diagnostic performance studies<\/p>\n<\/td>\n

\n

\nPoster #102804<\/p>\n

\n30 July 2025, 7:30am – 4:15pm EDT<\/p>\n

\nImke Kirste<\/span>, David Caley, Clara Quijano Rubio, Margherita Carboni<\/p>\n

\n\u00a0<\/p>\n

\n\u00a0<\/p>\n<\/td>\n<\/tr>\n

\n

\nInvestigating Differences in Patients Enrolled in a Clinical Study Based on Referral Type<\/p>\n<\/td>\n

\n

\nPoster #108110<\/p>\n

\n30 July 2025, 7:30am – 4:15pm EDT<\/p>\n

\nSophie Roth<\/span>, Laura Schlieker, Sayuri Hortsch, Joana Amorim Freire, David Caley<\/p>\n

\n\u00a0<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nAbout trontinemab<\/b><\/p>\n

\nTrontinemab is an investigational Brainshuttle bispecific 2+1 amyloid-beta targeting monoclonal 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.<\/p>\n

\nThe uniqueness of trontinemab is based on Roche’s proprietary Brainshuttle technology combining an amyloid beta-binding 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.<\/p>\n

\nAbout Roche in Alzheimer\u2019s Disease<\/b><\/p>\n

\nWith more than two decades of scientific research in Alzheimer\u2019s disease, Roche is working towards a day when we can detect and treat the disease early, in order to slow down, stop or even prevent its progression to preserve what makes people who they are. Today, the company\u2019s Alzheimer\u2019s disease portfolio spans investigational medicines for different targets, types and stages of the disease, including trontinemab. On the diagnostics side, it also includes approved and investigational tools, including digital and blood-based tests and CSF assays, aiming to more effectively detect, diagnose and monitor the disease. Yet the global challenges of Alzheimer\u2019s disease go well beyond the capabilities of science, and making a meaningful impact requires collaboration both within the Alzheimer\u2019s community and outside of healthcare. Roche will continue to work together with numerous partners with the hope to transform millions of lives.<\/p>\n

\nAbout Genentech in Neuroscience<\/b><\/p>\n

\nNeuroscience is a major focus of research and development at Genentech. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.<\/p>\n

\nGenentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer\u2019s disease, Huntington\u2019s disease, Parkinson\u2019s disease and Duchenne muscular dystrophy. 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.<\/p>\n

\nAbout Genentech<\/b><\/p>\n

\nFounded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http:\/\/www.gene.com<\/a>.<\/p>\n

Contacts<\/b> <\/p>\n

\nMedia Contact: Meghan Hindman (650) 467-6800
\n
Advocacy Contact: Jenee Williams (650) 303-2958
\n
Investor Contacts: Loren Kalm (650) 225-3217
\n
Bruno Eschli +41616875284<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u2013 Trontinemab\u2019s Phase Ib\/IIa Brainshuttle\u2122 AD study continues to show rapid and robust clearance of amyloid plaques, with 91% becoming amyloid PET negative and ARIA-E remaining <5% \u2013 \u2013 Design of the Phase III TRONTIER 1 and 2 studies of trontinemab in early symptomatic Alzheimer\u2019s disease featured, with initiation planned in 2025 \u2013 \u2013 Plans … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-61645","6":"format-standard","7":"category-industry"},"yoast_head":"\nGenentech and Roche Present New Insights in Alzheimer\u2019s Disease Research Across Its Diagnostics and Pharmaceutical Portfolios at AAIC - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/genentech-and-roche-present-new-insights-in-alzheimers-disease-research-across-its-diagnostics-and-pharmaceutical-portfolios-at-aaic\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Genentech and Roche Present New Insights in Alzheimer\u2019s Disease Research Across Its Diagnostics and Pharmaceutical Portfolios at AAIC - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"\u2013 Trontinemab\u2019s Phase Ib\/IIa Brainshuttle\u2122 AD study continues to show rapid and robust clearance of amyloid plaques, with 91% becoming amyloid PET negative and ARIA-E remaining <5% \u2013 \u2013 Design of the Phase III TRONTIER 1 and 2 studies of trontinemab in early symptomatic Alzheimer\u2019s disease featured, with initiation planned in 2025 \u2013 \u2013 Plans ... 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