Genentech and Roche Present Novel Therapeutic and Diagnostic Advancements in Alzheimer’s at AD/PD 2025
Genentech and Roche presented significant advancements in Alzheimer's treatment and diagnostics at AD/PD 2025. The Phase Ib/IIa Brainshuttle AD study of trontinemab showed promising results, with 81% of participants in the 3.6 mg/kg dose group experiencing amyloid plaque reduction below threshold after 28 weeks. The drug demonstrated a favorable safety profile with ARIA-E observed in less than 5% of participants.
The company's Elecsys pTau181 plasma test showed potential in accurately ruling out amyloid pathology in a study of 604 participants. This minimally invasive blood test is expected to be available in Europe by late 2025. Additionally, Phase III trials for trontinemab will commence later this year.
In Parkinson's research, the Phase IIb PADOVA study of prasinezumab, while missing its primary endpoint, showed possible benefits in early-stage Parkinson's disease, particularly in levodopa-treated patients.
Genentech e Roche hanno presentato importanti progressi nel trattamento e nella diagnosi dell'Alzheimer all'AD/PD 2025. Lo studio Brainshuttle AD di trontinemab di fase Ib/IIa ha mostrato risultati promettenti, con l'81% dei partecipanti nel gruppo a dose di 3,6 mg/kg che ha registrato una riduzione delle placche amiloidi al di sotto della soglia dopo 28 settimane. Il farmaco ha dimostrato un profilo di sicurezza favorevole, con ARIA-E osservato in meno del 5% dei partecipanti.
Il test plasmatico Elecsys pTau181 dell'azienda ha mostrato potenziale nell'escludere con precisione la patologia amiloide in uno studio su 604 partecipanti. Questo test del sangue minimamente invasivo dovrebbe essere disponibile in Europa entro la fine del 2025. Inoltre, gli studi di fase III per trontinemab inizieranno entro la fine di quest'anno.
Nella ricerca sul Parkinson, lo studio di fase IIb PADOVA di prasinezumab, pur non raggiungendo il suo obiettivo primario, ha mostrato possibili benefici nella malattia di Parkinson in fase iniziale, in particolare nei pazienti trattati con levodopa.
Genentech y Roche presentaron avances significativos en el tratamiento y diagnóstico del Alzheimer en AD/PD 2025. El estudio de fase Ib/IIa Brainshuttle AD de trontinemab mostró resultados prometedores, con el 81% de los participantes en el grupo de dosis de 3,6 mg/kg experimentando una reducción de la placa amiloide por debajo del umbral después de 28 semanas. El fármaco demostró un perfil de seguridad favorable, con ARIA-E observado en menos del 5% de los participantes.
La prueba plasmática Elecsys pTau181 de la compañía mostró potencial para descartar con precisión la patología amiloide en un estudio de 604 participantes. Se espera que esta prueba de sangre mínimamente invasiva esté disponible en Europa a finales de 2025. Además, los ensayos de fase III para trontinemab comenzarán a finales de este año.
En la investigación del Parkinson, el estudio de fase IIb PADOVA de prasinezumab, aunque no alcanzó su objetivo primario, mostró posibles beneficios en la enfermedad de Parkinson en etapa temprana, particularmente en pacientes tratados con levodopa.
제넨텍과 로슈는 AD/PD 2025에서 알츠하이머 치료 및 진단의 중요한 발전을 발표했습니다. 트론티네맙의 Brainshuttle AD 연구는 3.6 mg/kg 용량 그룹의 81%가 28주 후에 아밀로이드 플라크가 기준 이하로 감소하는 긍정적인 결과를 보였습니다. 이 약물은 5% 미만의 참여자에게서 ARIA-E가 관찰되는 우호적인 안전성 프로필을 나타냈습니다.
회사의 Elecsys pTau181 혈장 검사는 604명의 참가자를 대상으로 한 연구에서 아밀로이드 병리를 정확하게 배제하는 데 잠재력을 보였습니다. 이 최소 침습적인 혈액 검사는 2025년 말까지 유럽에서 이용 가능할 것으로 예상됩니다. 또한, 트론티네맙에 대한 3상 시험이 올해 말에 시작될 것입니다.
파킨슨 연구에서, 프라시네주맙의 2b상 PADOVA 연구는 주요 목표를 달성하지 못했지만, 초기 단계 파킨슨병에서 특히 레보도파 치료를 받은 환자들에게 가능한 이점을 보여주었습니다.
Genentech et Roche ont présenté des avancées significatives dans le traitement et le diagnostic de la maladie d'Alzheimer lors de l'AD/PD 2025. L'étude de phase Ib/IIa Brainshuttle AD sur le trontinemab a montré des résultats prometteurs, avec 81 % des participants du groupe à dose de 3,6 mg/kg ayant constaté une réduction des plaques amyloïdes en dessous du seuil après 28 semaines. Le médicament a montré un profil de sécurité favorable, avec ARIA-E observé chez moins de 5 % des participants.
Le test plasmatique Elecsys pTau181 de l'entreprise a montré un potentiel pour exclure avec précision la pathologie amyloïde dans une étude de 604 participants. Ce test sanguin peu invasif devrait être disponible en Europe d'ici fin 2025. De plus, les essais de phase III pour le trontinemab commenceront plus tard cette année.
Dans la recherche sur le Parkinson, l'étude de phase IIb PADOVA sur le prasinezumab, bien qu'elle n'ait pas atteint son objectif principal, a montré des avantages possibles dans la maladie de Parkinson à un stade précoce, en particulier chez les patients traités par lévodopa.
Genentech und Roche haben auf der AD/PD 2025 bedeutende Fortschritte in der Behandlung und Diagnostik von Alzheimer präsentiert. Die Phase Ib/IIa Brainshuttle AD-Studie zu Trontinemab zeigte vielversprechende Ergebnisse, wobei 81 % der Teilnehmer in der 3,6 mg/kg-Dosierungsgruppe nach 28 Wochen eine Reduzierung der Amyloid-Plaques unter dem Schwellenwert erlebten. Das Medikament wies ein günstiges Sicherheitsprofil auf, wobei ARIA-E bei weniger als 5 % der Teilnehmer beobachtet wurde.
Der Elecsys pTau181 Plasma-Test des Unternehmens zeigte Potenzial, um Amyloidpathologie genau auszuschließen, in einer Studie mit 604 Teilnehmern. Dieser minimalinvasive Bluttest wird voraussichtlich Ende 2025 in Europa verfügbar sein. Darüber hinaus werden die Phase-III-Studien für Trontinemab noch in diesem Jahr beginnen.
In der Parkinsonforschung zeigte die Phase-IIb PADOVA-Studie zu Prasinezumab, dass, obwohl das primäre Ziel verfehlt wurde, mögliche Vorteile bei der frühen Parkinson-Krankheit, insbesondere bei mit Levodopa behandelten Patienten, bestehen.
- Strong efficacy data: 81% of participants showed amyloid reduction with 3.6 mg/kg trontinemab dose
- Favorable safety profile with low ARIA-E incidence (<5%)
- Phase III program advancement for trontinemab
- New diagnostic test development showing promising results
- Prasinezumab missed primary endpoint in Phase IIb Parkinson's study
- Delayed U.S. availability of Elecsys pTau181 test compared to Europe
– 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 –
– A Phase III program for trontinemab later this year will be initiated based on totality of data –
“We are pleased with the progress across our Alzheimer’s portfolio as we move ahead with a Phase III trontinemab program and continue to expand our diagnostic solutions,” said Levi Garraway, M.D., Ph.D., 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 favorable 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 multicenter 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
Other activities at the AD/PD 2025 International Conference
Parkinson’s disease
Results from the Phase IIb
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
Roche entered into a Licensing, Development, and Commercialization agreement with Prothena in December 2013 to develop and commercialize monoclonal antibodies targeting α-syn, such as prasinezumab, for the treatment of Parkinson’s disease.
About Genentech in Neuroscience
Neuroscience 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.
Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s 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.
About Genentech
Founded 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
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FAQ
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