ROCHE HOLDING AG Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it will present 16 new data presentations across its Alzheimer’s disease (AD) pipeline at this year’s Alzheimer's Association International Conference (AAIC) from July 22-26 in Chicago, Illinois. Roche and Genentech’s AD pipeline includes two late-stage investigational molecules, crenezumab and gantenerumab, which are both in Phase III clinical trials, and an anti-tau molecule in Phase II.
“The range of data that Roche and Genentech are presenting at AAIC is a testament to our commitment to bring new treatments to help the many millions of people living with Alzheimer’s disease,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development.
In a late-breaking session, an exploratory analysis is being presented on crenezumab from the completed Phase II BLAZE and ABBY clinical trials that will show the impact of crenezumab treatment over the whole trial duration on beta amyloid oligomer levels in cerebrospinal fluid (CSF) in people with mild to moderate AD. Baseline data from the CREAD 1 study in prodromal to mild AD will also be presented. Crenezumab is an investigational, monoclonal antibody designed to preferentially bind to and promote removal of oligomers, a form of beta amyloid.
Additionally, updates from open-label extension studies of gantenerumab, including data on the effects of higher doses of gantenerumab in reducing amyloid PET load at 24 months, as well as long-term safety data, will be presented. Data on the effects of low doses of gantenerumab on amyloid and tau biomarkers in CSF will also be presented. Gantenerumab is an investigational, monoclonal antibody designed to bind to aggregated beta amyloid and remove beta amyloid plaques. Two recently initiated Phase III GRADUATE clinical studies are evaluating the safety and efficacy of gantenerumab for the treatment of early AD.
The full range of data from Roche and Genentech’s Alzheimer’s clinical development program, including investigational medicines and diagnostics, being presented at AAIC include:
Investigational | Abstract Title |
Abstract Number (type), | ||
| Crenezumab | LATE BREAKER: Target Engagement in an AD Trial: Crenezumab Lowers Aβ Oligomer Levels in CSF |
DT-02-03 (platform), | ||
| Baseline Characteristics from a Phase 3 Trial of Crenezumab in Prodromal to Mild Alzheimer’s Disease (CREAD) |
O1-02-04 (platform), | |||
| Gantenerumab | The Effect of Low Doses of Gantenerumab on Amyloid and Tau Biomarkers in Cerebrospinal Fluid (CSF) in the Marguerite Road Study |
O1-09-02 (platform), | ||
| 24-Month Amyloid PET Results of the Gantenerumab High-Dose Open Label Extension Studies |
O1-09-03 (platform), | |||
| Update on the Safety and Tolerability of Gantenerumab in the Ongoing Open-Label Extension (OLE) of the Marguerite Road Study in Patients with Mild Alzheimer’s Disease (AD) after Approximately Two Years of Study Duration |
O1-09-04 (platform), | |||
| Update on the Safety and Tolerability of Gantenerumab in the Ongoing Open-Label Extension of the Scarlet Road Study in Patients with Prodromal Alzheimer's Disease after Approximately 2 Years of Study Duration |
O1-09-05 (platform), | |||
| CSF Biomarkers | LATE BREAKER: Detecting Brain Amyloid Status Using Fully Automated Plasma Aβ Biomarker Assays |
DT-02-04 (platform), | ||
| Analysis of Cerebrospinal Fluid (CSF) Biomarkers to Predict Risk of Clinical Decline and Progression to Dementia in Patients with Mild Cognitive Impairment and Mild Cognitive Symptoms |
P3-267 (poster), | |||
| Multicenter Evaluation of the Analytical Characteristics of the Elecsys® Total-Tau Cerebrospinal Fluid (CSF) and Elecsys® Phospho-Tau (181P) CSF Immunoassays |
P1-285 (poster), | |||
| Technical Validation and Multicenter Evaluation of the Elecsys® β-Amyloid 1–40 Prototype Immunoassay for Quantitation in Cerebrospinal Fluid (CSF) |
P1-272 (poster) | |||
| A Unified Pre-Analytical Protocol for Handling of CSF Samples before Analyses of AD Biomarker Levels |
O2-09-02 (platform), | |||
| CSF Biomarkers in the General Population: Associations with Demographics and APOE Genotype |
O2-04-05 (platform), | |||
| Diagnostic Performance of Elecsys® Immunoassays for Cerebrospinal Fluid Alzheimer’s Disease Biomarkers in a Non-Academic Multicenter Memory Clinic Cohort: the ABIDE Project |
O2-09-03 (platform), | |||
| PET Tau Tracers | Tau Burden Measured Using [18F]GTP1 Correlates with CSF Tau Phosphorylation at Sites T217 and T205 More Closely Than T181 |
O3-14-02 (platform), | ||
Baseline Tau Burden Measured by [18F]GTP1 Imaging is Associated with Subsequent Cognitive Decline in Prodromal to Mild Alzheimer’s Disease |
P4-353 (poster), | |||
| Non-Molecule | Estimand in Early Alzheimer’s Disease: Progress Update from the International Alzheimer’s Disease Scientific Working Group (AD SWG) Substream |
P4-014 (poster), |
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About crenezumab
Crenezumab is an investigational, monoclonal antibody designed to preferentially bind to and promote removal of neurotoxic oligomers, a form of beta amyloid. Crenezumab has an antibody backbone (IgG4) designed to minimize the inflammatory response in the brain, which may result in a lower risk of MRI abnormalities. It is currently being studied in two Phase III, two-year, randomized, double-blind, placebo-controlled, multicenter clinical trials (CREAD 1 and 2) in early AD. Based on the learnings from two completed Phase II trials, the CREAD studies are using higher doses of crenezumab and have enrolled people with early AD who have confirmed AD pathology. These studies are now fully enrolled. Crenezumab is also being studied in a landmark Alzheimer’s Prevention Initiative (API) trial of cognitively healthy individuals in Colombia with an autosomal dominant mutation who are at risk to develop early-onset AD. Crenezumab is being developed by Roche and Genentech and was discovered by Swiss biotechnology company AC Immune SA.
About gantenerumab
Gantenerumab is an investigational, monoclonal antibody designed to bind to aggregated beta amyloid and remove beta amyloid plaques. It is being investigated in two Phase III studies (GRADUATE 1 and 2) for the treatment of early AD. In completed Phase III clinical studies, gantenerumab removed beta amyloid plaques, which have been shown to be toxic to the brain. Ongoing open-label extension studies have informed the design of the GRADUATE program. The new studies, which are enrolling people with early AD with confirmed AD brain pathology, include higher doses of gantenerumab. The target dose is achieved through a titration regimen to optimize safety. Gantenerumab is also being studied as part of the DIAN-TU trial, a worldwide clinical study evaluating multiple compounds in individuals at risk for or with a type of early-onset AD caused by a genetic mutation. Gantenerumab is being developed by Roche and Genentech and was identified and optimized by phage display technology in cooperation with MorphoSys AG, a Munich-based Biotech.
About Alzheimer’s disease
Alzheimer’s disease is a progressive, fatal disease of the brain that gradually destroys memory, thinking skills and problem solving and impairs daily functioning such as the ability to manage one’s own activities. Biological changes are believed to start decades before clinical symptoms of Alzheimer’s disease become evident. In the early stages (prodromal to mild dementia), people may have difficulty remembering things, but daily function may or may not be impaired. In the later stage of the disease, people increasingly become reliant on others for even simple day-to-day tasks. Dementia affects 44 million people worldwide with 7.7 million new cases each year, of which Alzheimer’s disease is the most common form. There is no cure for Alzheimer’s disease. Current treatments focus on alleviating symptoms and are unable to stop Alzheimer’s from progressing because they do not affect the disease’s underlying causes.
About Genentech in neuroscience
Neuroscience is a major focus of research and development at Genentech and Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease and autism.
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 South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
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