INDIANAPOLIS, 13 March 2021 / PRNewswire / – Phase 2 TRAILBLAZER-ALZ results presented today by Eli Lilly and Company (NYSE: LLY) at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases 21 2021 (AD / PD ™ 2021) were virtually presented 9-14 March 2021 and simultaneously published in the New England Journal of Medicine (NEJM) elaborates on previously reported topline data that found that donanemab reached its primary endpoint and showed a significant slowdown in the decline on the Integrated Alzheimer’s Disease Scale (iADRS), a composite measure of cognition and daily function. in patients with early symptomatic Alzheimer’s disease compared to placebo1.2.
In addition, data from secondary analyzes showed that donanemab slowed the cognitive and functional decline slowly, ranging between 20–40 percent in all secondary endpoints. [Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog13), Alzheimer’s Disease Cooperative Study-instrumental Activities of Daily Living (ADCS-iADL), Mini-Mental State Examination (MMSE)] with nominal statistical significance multiple times compared to placebo. Furthermore, specified investigative analyzes showed that donanemab delayed the accumulation of tau across important brain regions in patients affected by Alzheimer’s disease.
“We are confident in the results of the TRAILBLAZER-ALZ study,” he said. Daniel Skovronsky, MD, Ph.D., Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories. “This is the first late-stage study in Alzheimer’s disease to reach the primary endpoint during primary analysis. Donanemab has the potential to become a very important treatment for Alzheimer’s disease. We were pleased to not only slow down the cognitive and functional decline, but. also very significant clearance of amyloid plaques and the slowing of the spread of tau pathology.The constellation of clinical and biomarker results indicates the potential for long-term change of diseases.We are grateful to the patients, caregivers and investigators who participated in this important study has. . “
Specifically, at 76 weeks compared to baseline, donanemab treatment slowed the decrease by 32 percent compared to placebo, as measured by the iADRS, which was statistically significant. Already nine months (36 weeks) after the start of treatment, a significant difference in decrease was observed by iADRS.
In addition, 40 percent of participants treated with donanemab achieved amyloid negativity six months after starting treatment, and 68 percent achieved this target at 18 months. Donanemab is a monoclonal antibody designed to bind a specific form of post-translationally modified Aβ, N-terminal pyroglutamate, resulting in rapid and complete clearance of amyloid plaques.
“Tau has been increasingly validated as a predictive biomarker for Alzheimer’s progression, as again demonstrated in this trial,” he said. Liana G. Apostolova, MD, M.Sc., FAAN, Indiana University (IU) Leading Professor and Barbara and Peer Baekgaard Professor of Alzheimer’s Disease Research at the IU School of Medicine. An important insight into the results of the TRAILBLAZER-ALZ study is that donanemab not only significantly reduced the amount of amyloid deposition in these patients, but also slowed the clinical progression of the disease, suggesting that it was a disease-altering “We believe these imaging data of amyloids and tau lay the foundation for precision medicine-based treatments for Alzheimer’s disease.”
The safety profile of donanemab is consistent with observations from Phase 1 data. In the donanemab treatment group, amyloid-related imaging disorders – edema (ARIA-E) occurred in 26.7 percent of the treated participants, with an overall prevalence of 6.1 percent experiencing ARIA-E symptomatically; the majority of ARIA-E cases occurred within the first 12 weeks after starting treatment. Other common AEs in the donanemab treatment group include ARIA-H-related events such as microbleeds (7.6 percent) and superficial central nervous system siderosis (13.7 percent), nausea (10.7 percent), and infusion-related reaction. (IRR) (7.6 percent). . Severe IRR or hypersensitivity occurred in 2.3 percent of the participants treated with donanemab. In the donanemab arm, 30.5 percent of patients discontinued treatment due to an adverse event, and half of this discontinuation was due to ARIA-related events. Patients on discontinuation of treatment were allowed to continue in the trial.
“As a clinician and researcher, I am particularly encouraged by the significant reduction of the plaque and the slowing down of clinical deterioration with donanemab,” he said. Stephen P. Salloway, MS, MD, director of the memory and aging program and the Department of Neurology at Butler Hospital and Martin M. Zucker Professor of Psychiatry and Human Behavior, Department of Neurology, Warren Alpert Medical School of Brown University. “The results of donanemab are an important and encouraging milestone for people affected by Alzheimer’s disease, and we are eager to continue in this fight.”
Talks with regulators continue and an update of the clinical trial program TRAILBLAZER will be on a webcast on Monday 15 March by 10:30 EDT including an update on the ongoing TRAILBLAZER-ALZ 2 trial. Visit www.trailblazer2study.com for more information on the TRAILBLAZER-ALZ 2 study or to see if you qualify.
About TRAILBLAZER-ALZ study
TRAILBLAZER-ALZ (NCT03367403) is a randomized, placebo-controlled, double-blind, multicenter phase 2 study to evaluate the safety, tolerability and efficacy of donanemab in patients with early symptomatic Alzheimer’s disease. The trial enrolled 272 patients selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau setup by PET imaging. The primary endpoint of the study is the change from baseline to 76 weeks in the Integrated Alzheimer’s Disease Rating Scale (iADRS), a composite instrument that measures the Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog13) and the Alzheimer’s Disease Cooperative Study combine – instrumental activities of Daily Living (ADCS-iADL) for function. Important secondary endpoints include changes between baseline and 76 weeks in the scale-cognitive subscale of Alzheimer’s disease (ADAS-Cog13), the ADCS-iADL, MMSE, and clinical dementia rating scale (CDR-SB). Other secondary endpoints for biomarkers include changes from baseline to week 76 in brain amyloid deposition and precipitation of the brain and volumetric MRI. The safety, tolerability and efficacy of donanemab are also evaluated in the ongoing randomized, placebo-controlled, double-blind, multicenter phase 2 study TRAILBLAZER-ALZ 2 (NCT04437511).
About Alzheimer’s disease
Alzheimer’s disease is a deadly disease that gradually decreases in memory and other aspects of cognition. Dementia due to Alzheimer’s disease is the most common form of dementia, accounting for 60 to 80 percent of all cases.3. There are currently more than 50 million people with dementia living around the world, and the numbers are expected to increase to nearly 152 million by 2050.4. Worldwide, nearly 10 million new cases of dementia are diagnosed worldwide, meaning one new case every 3 seconds, and a significant increase in the burden of care that society and families place. In the US alone, there was an increase of 8 million new caregivers from 2015 to 20205. The current annual societal and economic costs of dementia are estimated at $ 1 trillion, an amount that is expected to double by 2030, unless we find a way to delay the disease4.
About Eli Lilly and Company
Lilly is a global leader in healthcare that combines care with discovery to make life better around the world. We were founded more than a century ago by a man committed to creating high-quality medicine that meets real needs, and today we remain true to the mission in all our work. Around the world, Lilly’s employees are working to discover and bring life – changing medicine to those in need, improve disease understanding and management, and give it back to communities through philanthropy and volunteering. For more information on Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY
Lilly Warning Statement for Forward-Looking Statements
This press release contains forward-looking statements (as the term is defined in the Private Security Reform Act 1995) on the platform of Lilly’s Alzheimer’s disease, including donanemab as a possible treatment for people with early symptomatic Alzheimer’s disease and reflects Lilly’s current beliefs and expectations. . As with such ventures, however, there are major risks and uncertainties in the process of drug research, development and commercialization. Among other things, there is no guarantee that future study results will be consistent with the study results to date, that donanemab will be a safe and effective treatment, or that donanemab will receive regulatory approval. For further discussion of these and other risks and uncertainties, see Lilly’s Form 10-K and Form 10-Q filing with the U.S. Securities and Exchange Commission. Except as required by law, Lilly is under no obligation to update forward-looking statements after events after the date of this release.
- Mintun M, Lo AC, et. al. Donanemab delays the progression of early symptomatic Alzheimer’s disease in phase 2 evidence of conception trial. Actually presented at the International Conference on Alzheimer & Parkinson’s Diseases 21 2021 (AD / PD ™ 2021); March 9-14.
- Mintun M, Lo AC, et. al. (2021). Donanemab in early Alzheimer’s disease. New England Journal of Medicine, https://www.nejm.org/doi/full/10.1056/NEJMoa2100708.
- Alzheimer’s Association. Facts and figures. https://www.alz.org/alzheimers-dementia/facts-figures. Access December 8, 2020.
- Alzheimer’s disease internationally. World Alzheimer’s Report 2019. https://www.alz.co.uk/research/WorldAlzheimerReport2019.pdf. Access December 8, 2020.
- AARP. Report 2020: Care in the US https://www.aarp.org/content/dam/aarp/ppi/2020/05/full-report-caregiving-in-the-united-states.doi.10.26419-2Fppi.00103.001 .pdf. Access December 8, 2020.
SOURCE Eli Lilly and Company
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