Crenezumab data advance understanding of prevention efforts for autosomal dominant Alzheimer’s
Detailed results from the phase II Alzheimer’s Prevention Initiative Autosomal Dominant Alzheimer's Disease (API ADAD) Trial will be presented. The trial did not demonstrate a statistically significant clinical benefit in either of its co-primary endpoints, evaluating crenezumab’s ability to slow or prevent Alzheimer’s disease in people with a specific genetic mutation after five to eight years of treatment compared with placebo. Data will be featured in the AAIC News Briefing on Tuesday, 2 August at 7:00 a.m. PT followed by a Scientific Session at 8:00 a.m. PT. Researchers will discuss the trial’s design, clinical outcomes, brain imaging, and cerebrospinal fluid (CSF) biomarker findings.

Diagnostics continues to drive innovation in improving timely diagnosis of Alzheimer’s
Study results leading to the selection of blood based biomarkers used in the Elecsys Amyloid Plasma Panel, a test with the potential to aid in the detection of people with amyloid pathology, will be presented on Tuesday, 2 August. The Elecsys Amyloid Plasma Panel, which was recently granted FDA Breakthrough Device Designation, has the potential to better direct individuals towards a confirmatory Alzheimer’s diagnosis, either with amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing, where appropriate.

Data presentations across Roche’s Alzheimer’s disease portfolio

About Roche in Alzheimer’s disease
With over two decades of scientific research in Alzheimer’s, Roche is working towards a day when we can detect the disease early and stop its progression to preserve what makes people who they are. Today, the company’s Alzheimer’s portfolio spans investigational medicines for different targets, types and stages of the disease. It also includes diagnostic tools, including digital, blood-based and cerebrospinal fluid (CSF) tests, aiming to more effectively detect, diagnose, and monitor the disease. Yet the global challenges of Alzheimer’s go well beyond the capabilities of science, and making a meaningful impact requires collaboration both within the Alzheimer’s community and outside of healthcare. Roche will continue to work together with numerous partners with the hope of transforming millions of lives.

About gantenerumab
Gantenerumab is a fully-human monoclonal IgG1 antibody, an investigational medicine that is subcutaneously administered and designed to target and bind to aggregated forms of beta-amyloid and activate immune cells in the brain (microglia) to clear amyloid plaques and prevent further accumulation.

Gantenerumab is currently being investigated in eight clinical trials, including:

• GRADUATE I and II, two Phase III studies investigating the efficacy and safety of gantenerumab compared with placebo in up to 1000 participants per study who have early Alzheimer’s over 27 months. Results are expected in Q4, 2022.

• GRADUATION, an open-label study to evaluate the pharmacodynamic effects of once weekly administration in participants with early Alzheimer’s.

• Post-GRADUATE, a rollover open-label study for GRADUATE I and II to continue assessing the efficacy and safety of gantenerumab in participants with early AD.

• Open RoAD, a rollover open-label study for the former SCarlet RoAD and Marguerite RoAD OLEs to continue to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with Alzheimer’s.

• DIAN-TU-002 Primary Prevention, an investigator-initiated study evaluating whether Alzheimer’s can be prevented in people with a genetic predisposition to developing rare, early-onset forms of the disease called Autosomal Dominant Alzheimer’s disease (ADAD). Unlike most Alzheimer’s prevention studies, it enrols people up to 25 years before the disease has started in the brain.

• DIAN-TU-001 OLE, an exploratory extension study in people with ADAD who presented with or were close to the expected symptoms of Alzheimer’s at baseline of the double-blind study, aiming to further investigate the relationship of biomarker changes with cognitive and clinical findings.

• SKYLINE, a Phase III secondary prevention trial to evaluate the efficacy and safety of gantenerumab in participants at risk for or at the earliest stages of Alzheimer's.

About crenezumab
Crenezumab is an investigational, monoclonal antibody designed to neutralise neurotoxic oligomers, a form of beta-amyloid. Crenezumab has an antibody backbone (IgG4) designed to minimise the inflammatory response in the brain, which may result in a lower risk of certain MRI (magnetic resonance imaging) abnormalities known as ARIA (Amyloid-Related Imaging Abnormalities). The investigational medicine is being developed by Genentech and is part of a collaboration with AC Immune SA.

About semorinemab
Semorinemab is an investigational monoclonal anti-tau antibody that targets the N-terminal portion of the tau protein, and is designed to bind to tau and slow its spread between neurons. In tauopathies such as Alzheimer’s, tau misfolds and forms tangles, which cause cell damage and ultimately neuronal death. It is hypothesised that abnormal tau protein then spreads between neurons, gradually involving more areas of the brain, and leading to clinical disease progression. Tau-targeting antibody therapies are designed to slow or stop this process of tau spread. The investigational medicine is being developed by Genentech and is part of a collaboration with AC Immune SA.

About the Elecsys® Amyloid Plasma Panel
The Elecsys Amyloid Plasma Panel measures phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma. Elevations in pTau occur in early stages of Alzheimer’s, while the presence of APOE E4 constitutes the most common genetic risk factor for Alzheimer’s disease. The result is intended for consideration in conjunction with other clinical information to advise physicians on whether there is a need for further confirmatory testing for Alzheimer’s disease with amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. Individuals testing negative with the Elecsys Amyloid Plasma Panel are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline

About Roche in neuroscience
Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Roche has approved and investigational medicines across multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, myasthenia gravis, 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 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.

In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

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.

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Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

 

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