INDIANAPOLIS, March 13, 2021 / PRNewswire / – Results of Phase 2 TRAILBLAZER-ALZ presented today by Eli Lilly and Company (NYSE: LLY) at the 15th International Conference on Alzheimer’s and Parkinson’s ™ 2021 (AD / PD ™ 2021) took place March 9-14, 2021 and published simultaneously in New England Journal of Medicine (NEJM) are based on previously reported top data, which found that donanemab met its primary endpoint and showed a significant slowdown in the integrated scale of Alzheimer’s disease assessment (iADRS), a composite measure of knowledge and function. daily in patients with early symptomatic Alzheimer’s. disease compared to placebo1.2.
In addition, data from secondary analyzes showed that donanemab steadily slowed cognitive and functional decline, with ranges ranging from 20-40 percent in all secondary targets. [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 several times compared to placebo. Furthermore, pre-specified exploratory analyzes showed that donanemab slowed the accumulation of tau in key brain regions in patients with Alzheimer’s disease.
“We are confident in the results of the TRAILBLAZER-ALZ study,” he said Daniel Skovronsky, MD, Ph.D., Chief Scientific Officer of Lilly and President of Lilly Research Laboratories. “This is the first study in the late stage of Alzheimer’s disease that has reached its main goal in the primary analysis. Donanemab has the potential to become a very important treatment for Alzheimer’s disease. We were pleased to see not only the slowdown in cognitive and functional decline, but also the very substantial elimination of amyloid plaques and the slowdown in the spread of your pathology. The constellation of clinical and biomarker results indicates the potential for long-term change in the disease. We are grateful to the patients, caregivers and investigators who participated in this baseline study. “
Specifically, at 76 weeks compared to baseline, donanemab treatment slowed the decline by 32% compared with placebo, as measured by iADRS, which was statistically significant. As early as nine months (36 weeks) after initiation of treatment, a significant difference in decline was observed with iADRS.
In addition, 40% of donanemab-treated participants achieved amyloid negativity six months after starting treatment and 68% achieved this goal by 18 months. Donanemab is a monoclonal antibody that has been designed to bind a specific form of Aß, post-translational modified N-terminal pyroglutamate and thus produces a rapid and complete clearance of amyloid plaques.
“Tau has become increasingly validated as a predictive biomarker for Alzheimer’s disease progression, as shown again in this study,” he said. Liana G. Apostolova, MD, M.Sc., FAAN, Indiana University (IU) Distinguished Professor and Barbara and Peer Baekgaard Professor in Alzheimer’s Disease Research at the IU School of Medicine. “A key perspective of 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 this could be a disease-modifying therapy. We believe these amyloid imaging data and tau lay the groundwork for precision treatments based on Alzheimer’s disease drugs. ”
The safety profile of donanemab was consistent with observations from phase 1 data. In the donanemab treatment group, imaging abnormalities related to amyloid-edema (ARIA-E) occurred in 26.7% of treated participants, with an incidence of 6.1% who had symptomatic ARIA-E; most ARIA-E cases occurred within the first 12 weeks of starting treatment. Other common AEs in the donanemab treatment group include H-ARIA-related events such as microhemorrhages (7.6%) and superficial central nervous system siderosis (13.7%), nausea (10.7%), and reactions. related to infusion (IRR) (7.6%). Severe IRR or hypersensitivity occurred in 2.3% of donanemab-treated participants. In the donanemab arm, 30.5 percent of patients discontinued treatment due to an adverse event, and half of these discontinuations were due to ARIA-related events. Patients with treatment interruptions were allowed to continue the study.
“As a clinician and researcher, I am particularly encouraged by the significant decrease in plaque and the slowdown in clinical decline 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 in Brown University. The results of donanemab are a significant and encouraging step for people with Alzheimer’s disease and we look forward to continuing this fight.
Discussions with regulators are ongoing and an update to the TRAILBLAZER clinical trial program will be provided on a webcast on Monday, March 15 to 10:30 EDT including an update to the ongoing TRAILBLAZER-ALZ 2 process. To learn more about the TRAILBLAZER-ALZ 2 study or to see if you pre-qualify, visit www.trailblazer2study.com.
About the 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 study enrolled 272 patients who were selected based on cognitive assessments corroborated with amyloid plaque imaging and your staging by PET imaging. The main objective of the study is to change from baseline to 76 weeks the Integrated Alzheimer’s Disease Assessment Scale (iADRS), a composite tool that combines the Alzheimer’s Disease Assessment-Cognitive Subscale Scale (ADAS-Cog13) and the Cooperative Study of Alzheimer’s Disease. Alzheimer’s disease – Instrumental activities of the Daily Living (ADCS-iADL) for function. Key secondary endpoints include changes between baseline and 76 weeks in the Alzheimer’s-cognitive subscale disease assessment scale (ADAS-Cog13), ADCS-iADL, MMSE, and the Box Dementia Assessment Scale Box Amount (CDR-SB). Other secondary goals of the biomarker include changes from baseline to week 76 in cerebral amyloid deposition and your cerebral deposition and volumetric MRI. The safety, tolerability, and efficacy of donanemab are also evaluated in the Phase 2, randomized, placebo-controlled, double-blind, multi-center, phase 2 TRAILBLAZER-ALZ 2 study (NCT04437511).
About Alzheimer’s disease
Alzheimer’s disease is a fatal disease that causes a progressive decline in memory and other aspects of knowledge. Dementia caused by Alzheimer’s disease is the most common form of dementia, accounting for 60 to 80 percent of all cases.3. Today, more than 50 million people live with dementia worldwide, and the number is set to grow to nearly 152 million by 2050.4. Almost 10 million new cases of dementia are diagnosed each year worldwide, which means a new case every 3 seconds and a significant increase in the burden of caring for society and families. In the US alone, there has been an increase of 8 million new carers from 2015 to 20205. The current annual cost of the company and dementia is estimated at 1 trillion dollars, an amount that is expected to double by 2030, unless we find a way to slow down the disease4.
About Eli Lilly and Company
Lilly is a global health leader who combines care with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high quality medicines that meet real needs and today we remain faithful to this mission in all our work. Around the world, Lilly employees work to discover and bring life-changing medicines to those who need them, to improve their understanding and management of disease, and to give back to communities through philanthropy and volunteering. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY
Lilly’s warning statement about forward-looking statements
This press release contains forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995) about the Lilly Alzheimer’s Disease Platform, including donanemab as a potential treatment for people with early symptomatic Alzheimer’s disease and reflects current beliefs and expectations. to Lilly. . However, as with any such undertaking, there are substantial risks and uncertainties in the process of research, development and marketing of medicinal products. Among other things, there is no guarantee that the future results of the study will be consistent with the results of the study to date, that donanemab will prove to be a safe and effective treatment or that donanemab will receive regulatory approval. For further discussion of these risks and other risks and uncertainties, see Lilly’s 10-K and Form 10-Q filed with the United States Securities and Exchange Commission. Except as required by law, Lilly does not undertake to update forward-looking statements to reflect events subsequent to the date of this release.
- Mintun M, Lo AC, et. al. Donanemab slows the progression of early symptomatic Alzheimer’s disease in phase 2, evidence of the conceptual process. Practically presented at the International Conference on Alzheimer’s and Parkinson’s Diseases ™ 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 International. World Alzheimer’s Report 2019. https://www.alz.co.uk/research/WorldAlzheimerReport2019.pdf. access December 8, 2020.
- AARP. Report 2020: Caregiving 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.
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