Roche presents novel therapeutic and diagnostic advancements in Alzheimer’s at AD/PD 2025
Roche (RHHBY) has presented new data at AD/PD 2025 Conference showcasing advancements in Alzheimer's treatment and diagnostics. The company's trontinemab demonstrated promising Phase Ib/IIa results, showing rapid and deep amyloid plaque reduction in 81% of participants receiving 3.6 mg/kg dose after 28 weeks. The drug maintained a favorable safety profile with ARIA-E observed in less than 5% of participants.
The company plans to initiate a Phase III programme for trontinemab later this year. Additionally, Roche's Elecsys® pTau181 plasma test showed potential in accurately ruling out amyloid pathology in a study of 604 participants. This blood test is expected to be available in Europe by late 2025.
In Parkinson's disease research, the Phase IIb PADOVA study of prasinezumab, while missing its primary endpoint, showed possible benefits in early-stage patients, particularly those treated with levodopa.
Roche (RHHBY) ha presentato nuovi dati alla Conferenza AD/PD 2025, evidenziando i progressi nel trattamento e nella diagnosi dell'Alzheimer. Il trontinemab dell'azienda ha dimostrato risultati promettenti nella fase Ib/IIa, mostrando una rapida e profonda riduzione delle placche amiloidi nell'81% dei partecipanti che hanno ricevuto una dose di 3,6 mg/kg dopo 28 settimane. Il farmaco ha mantenuto un profilo di sicurezza favorevole, con ARIA-E osservato in meno del 5% dei partecipanti.
L'azienda prevede di avviare un programma di Fase III per il trontinemab entro la fine dell'anno. Inoltre, il test plasmatico Elecsys® pTau181 di Roche ha mostrato potenziale nel regolare con precisione la patologia amiloide in uno studio su 604 partecipanti. Questo test del sangue dovrebbe essere disponibile in Europa entro la fine del 2025.
Nella ricerca sulla malattia di Parkinson, lo studio di fase IIb PADOVA su prasinezumab, pur non raggiungendo il suo obiettivo primario, ha mostrato possibili benefici nei pazienti in fase precoce, in particolare in quelli trattati con levodopa.
Roche (RHHBY) ha presentado nuevos datos en la Conferencia AD/PD 2025 que destacan los avances en el tratamiento y diagnóstico del Alzheimer. El trontinemab de la compañía mostró resultados prometedores en la fase Ib/IIa, mostrando una rápida y profunda reducción de las placas amiloides en el 81% de los participantes que recibieron una dosis de 3,6 mg/kg después de 28 semanas. El medicamento mantuvo un perfil de seguridad favorable, con ARIA-E observado en menos del 5% de los participantes.
La compañía planea iniciar un programa de Fase III para el trontinemab más adelante este año. Además, el test plasmático Elecsys® pTau181 de Roche mostró potencial para descartar con precisión la patología amiloide en un estudio de 604 participantes. Se espera que esta prueba de sangre esté disponible en Europa a finales de 2025.
En la investigación sobre la enfermedad de Parkinson, el estudio de fase IIb PADOVA sobre prasinezumab, aunque no alcanzó su objetivo primario, mostró posibles beneficios en pacientes en etapas tempranas, particularmente en aquellos tratados con levodopa.
로슈 (RHHBY)는 AD/PD 2025 컨퍼런스에서 알츠하이머 치료 및 진단의 발전을 보여주는 새로운 데이터를 발표했습니다. 회사의 트론티네맙은 28주 후 3.6 mg/kg 용량을 받은 참가자 중 81%에서 빠르고 깊은 아밀로이드 플라크 감소를 보여주며 유망한 1상/2상 결과를 나타냈습니다. 이 약물은 참가자의 5% 미만에서 ARIA-E가 관찰되며 안전성 프로필을 유지했습니다.
회사는 올해 말에 트론티네맙에 대한 3상 프로그램을 시작할 계획입니다. 또한 로슈의 엘레크시스® pTau181 혈장 테스트는 604명의 참가자를 대상으로 한 연구에서 아밀로이드 병리를 정확하게 배제하는 데 잠재력을 보여주었습니다. 이 혈액 검사는 2025년 말까지 유럽에서 사용할 수 있을 것으로 예상됩니다.
파킨슨병 연구에서 프라시네주맙에 대한 2b상 PADOVA 연구는 주요 목표를 달성하지 못했지만, 특히 레바도파로 치료받은 초기 단계 환자에게 가능한 혜택을 보여주었습니다.
Roche (RHHBY) a présenté de nouvelles données lors de la Conférence AD/PD 2025, mettant en avant les avancées dans le traitement et le diagnostic de la maladie d'Alzheimer. Le trontinemab de l'entreprise a montré des résultats prometteurs lors de la phase Ib/IIa, affichant une réduction rapide et profonde des plaques amyloïdes chez 81 % des participants ayant reçu une dose de 3,6 mg/kg après 28 semaines. Le médicament a maintenu un profil de sécurité favorable, avec des cas d'ARIA-E observés chez moins de 5 % des participants.
L'entreprise prévoit de lancer un programme de Phase III pour le trontinemab plus tard cette année. De plus, le test plasmatique Elecsys® pTau181 de Roche a montré un potentiel pour exclure avec précision la pathologie amyloïde dans une étude portant sur 604 participants. Ce test sanguin devrait être disponible en Europe d'ici fin 2025.
Dans la recherche sur la maladie de Parkinson, l'étude de phase IIb PADOVA sur le prasinezumab, bien qu'elle n'ait pas atteint son objectif principal, a montré des bénéfices possibles chez les patients à un stade précoce, en particulier chez ceux traités par lévodopa.
Roche (RHHBY) hat auf der AD/PD 2025-Konferenz neue Daten präsentiert, die Fortschritte in der Behandlung und Diagnose von Alzheimer zeigen. Der Trontinemab des Unternehmens zeigte vielversprechende Ergebnisse der Phase Ib/IIa und wies nach 28 Wochen bei 81% der Teilnehmer, die eine Dosis von 3,6 mg/kg erhielten, eine schnelle und tiefe Reduktion der Amyloid-Plaques auf. Das Medikament wies ein günstiges Sicherheitsprofil auf, wobei ARIA-E bei weniger als 5% der Teilnehmer beobachtet wurde.
Das Unternehmen plant, später in diesem Jahr ein Phase-III-Programm für Trontinemab zu starten. Darüber hinaus zeigte der Elecsys® pTau181 Plasma-Test von Roche Potenzial, um Amyloidpathologie in einer Studie mit 604 Teilnehmern genau auszuschließen. Dieser Bluttest wird voraussichtlich Ende 2025 in Europa verfügbar sein.
In der Forschung zur Parkinson-Krankheit zeigte die Phase-IIb-Studie PADOVA zu Prasinezumab, obwohl sie ihr primäres Ziel verfehlte, mögliche Vorteile bei Patienten im Frühstadium, insbesondere bei denen, die mit Levodopa behandelt wurden.
- Strong efficacy data for trontinemab with 81% response rate in higher dose group
- Favorable safety profile with low ARIA-E incidence (<5%)
- Advancement to Phase III trials indicates development progress
- New diagnostic test could create additional revenue stream by late 2025
- Prasinezumab missed primary endpoint in Phase IIb PADOVA study
- Elecsys pTau181 test U.S. launch timeline remains uncertain
- New trontinemab data continue to support rapid and deep, dose-dependent reduction of amyloid plaques in Phase Ib/IIa Brainshuttle™ AD study
- Data on the Elecsys® pTau181 plasma test demonstrate potential to accurately rule out amyloid pathology, one of the hallmarks of Alzheimer’s disease
- Roche will initiate a Phase III programme for trontinemab later this year based on totality of data
Basel, 3 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data were presented at the AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases in Vienna, Austria. Highlights included presentations from the ongoing trontinemab Phase Ib/IIa Brainshuttle™ AD study demonstrating dose-dependent rapid amyloid depletion from the brain and the potential of the Elecsys® pTau181 plasma test to rule out amyloid pathology. Roche also announced the initiation of a Phase III programme for trontinemab, which is expected 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,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Well over 55 million people worldwide are living with dementia, of which around
Trontinemab
Preliminary results for trontinemab from 114 participants in the 1.8 or 3.6 mg/kg double-blind period suggest rapid and deep, dose-dependent reduction of amyloid plaques in the brain as measured by amyloid positron emission tomography (PET). Trontinemab reduced amyloid levels below the 24 centiloid threshold in
Trontinemab continues to show a favourable safety and tolerability profile. Amyloid-related imaging abnormalities-edema/effusion (ARIA-E) were observed in <
Trontinemab is currently being studied in the Phase Ib/IIa Brainshuttle AD study assessing the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of trontinemab in participants with Alzheimer's disease.
Diagnostics
Results from 604 participants in a multicentre study of Roche’s Elecsys pTau181 plasma test were presented, demonstrating its potential to accurately rule out amyloid pathology, a hallmark of Alzheimer’s disease, in people with cognitive impairment.
The Elecsys pTau181 test is a minimally invasive blood test that measures pTau181 protein in plasma. By ruling out those without signs of amyloid pathology, the test can help to avoid unnecessary testing using CSF or PET, which are more invasive and often come with long waiting times and high costs. This can result in further delays to diagnosis and cost to healthcare systems. Roche anticipates tests being available in Europe by late 2025, with the U.S. following after.
Other activities at the AD/PD 2025 International Conference
Parkinson’s disease
Results from the Phase IIb PADOVA study were presented for the first time, investigating prasinezumab in 586 people with early-stage Parkinson’s disease while on stable symptomatic treatment. Although the study missed its primary endpoint, the totality of data suggest possible benefit in early-stage Parkinson’s disease. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a hazard ratio (HR)=0.84 [0.69-1.01] and p=0.0657, missing statistical significance. In a pre-specified analysis, the effect of prasinezumab was more pronounced in the population treated with levodopa (
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.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
| Hans Trees, PhD Phone: +41 79 407 72 58 | Sileia Urech Phone: +41 79 935 81 48 |
| Nathalie Altermatt Phone: +41 79 771 05 25 | Lorena Corfas Phone: +41 79 568 24 95 |
| Simon Goldsborough Phone: +44 797 32 72 915 | Karsten Kleine Phone: +41 79 461 86 83 |
| Nina Mählitz Phone: +41 79 327 54 74 | Kirti Pandey Phone: +49 172 6367262 |
| Yvette Petillon Phone: +41 79 961 92 50 | Dr Rebekka Schnell Phone: +41 79 205 27 03 |
Roche Investor Relations
| Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com | Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com |
| Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com |
Investor Relations North America
| Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com |
Attachment
FAQ
What were the key results of Roche's (RHHBY) trontinemab Phase Ib/IIa trial in Alzheimer's?
When will Roche's (RHHBY) Elecsys pTau181 blood test be available in Europe?
What were the Phase IIb PADOVA study results for Roche's (RHHBY) prasinezumab?
When will Roche (RHHBY) begin Phase III trials for trontinemab?
