Eli Lilly and Company to Present More Than 40 Abstracts at the Alzheimer's Association International Conference® 2017 (AAIC® 2017)

Data highlights include important health outcomes data emphasizing the need for timely detection and management of Alzheimer's disease

INDIANAPOLIS, July 12, 2017 /PRNewswire/ -- Eli Lilly and Company LLY today announced it will present findings from more than 40 research studies at the upcoming Alzheimer's Association International Conference^® 2017 (AAIC^® 2017) in London, United Kingdom, July 16 - 20. The data highlight Lilly's broad Alzheimer's pipeline, including potential treatments and diagnostics in various stages of clinical development, in addition to health outcomes data on use of healthcare resources prior to an Alzheimer's disease diagnosis.

"Research shows that Alzheimer's disease begins to develop years before life-impacting symptoms appear. To effectively fight the disease, people with Alzheimer's, their caregivers and their doctors need more productive conversations sooner, with the goal to recognize and diagnose as early as possible," said Phyllis Ferrell, vice president, Global Alzheimer's Disease Platform Team. "We remain committed to finding solutions for Alzheimer's disease and believe promising new therapies are on the horizon."

Of particular interest is one oral presentation which may help inform the future care of Alzheimer's disease:

• Trends in Health Service Use and Potentially Avoidable Hospitalizations Prior to Alzheimer's Disease Diagnosis: A Matched, Retrospective Study of US Medicare Beneficiaries Oral presentation, Thursday, July 20, 12:00PM – 12:15PM. Presenting author: JS Andrews

Additional studies being presented include (please note, all times listed below are UK specific):

Solanezumab Data

• Plasma Pharmacokinetics and Pharmacodynamics of Solanezumab in Mild and Moderate AD Patients Poster presentation, Sunday, July 16, 9:30AM- 4:15PM. Presenting author: B Willis
• The Basics of Fluid Biomarkers in Alzheimer's Disease: Standardization, Quality Control and Regulatory Issues for Fluid Biomarkers Educational workshop, Friday, July 14, 8:00AM – 5:00PM. Presenting author: RA Dean
• Solanezumab Central Target Engagement and Pharmacodynamic Activity in the EXPEDITION 3 Trial of Patients with Mild AD: Comparison to EXPEDITION/EXPEDITION 2 Poster presentation, Sunday, July 16, 9:30AM – 4:15PM. Presenting author: J Raskin
• Deriving a Cut-Off for the Elecsys® β-Amyloid (1–42) Immunoassay for Use in Clinical Trials Supported by Eli Lilly for Patients with Clinically Defined Alzheimer's Disease Poster presentation, Wednesday, July 19, 9:30AM – 4:15PM. Presenting author: L. Shaw
• Effect of Solanezumab on Biomarkers of Neurodegeneration in the EXPEDITION3 Trial in Mild Alzheimer Disease Poster presentation, Saturday, July 15, 12:15PM – 1:30PM. Presenting author: AJ Schwarz
• Safety of Solanezumab in Phase 3 Studies in Individuals with Mild Alzheimer's Disease Dementia Poster presentation, Sunday, July 16, 9:30AM – 4:15PM. Presenting author: C Carlson
• Contemporary Issues in Clinical Trials Methods: Delayed Start Analysis in Phase 3 Solanezumab EXPEDITION3 Study in Mild Alzheimer's Disease Educational workshop, Friday, July 14, 8:00AM – 5:00PM. Presenting author: H Liu-Seifert
• Comparison of Baseline ARIA-H Prevalence at 1.5T and 3T MRI Field Strengths in a Multi-Site Global Clinical Trial with Cohort of 2137 AD Subjects Poster presentation, Sunday, July 16, 9:30AM – 4:15PM. Presenting author: A Schwarz
• The Integrated Alzheimer's Disease Rating Scale (iADRS) Findings from the EXPEDITION3 Trial Poster presentation, Wednesday, July 19, 9:30AM – 4:15PM. Presenting author: A Wessels
• The Patient Voice: Exploring Treatment Preferences in Participants with Mild Cognitive Concerns to Inform Regulatory Decision-Making Poster presentation, Wednesday, July 19, 9:30AM – 4:15PM. Presenting author: KE Bullok
• Big Pharma in VCID: What Will It Take? Featured research session, Wednesday, July 19, 5:15PM – 5:35PM. Presenting author: J Sims

Neurodegeneration Data 

• Establishing Microfluidic Devices As an in Vitro Neuronal Model for Studying Molecular and Functional Aspects of Transneuronal Tau Propagation Poster presentation, Tuesday, July 18, 9:30AM – 4:15PM. Presenting author: A Katsikoudi
• Investigating Glymphatic Function during Early Tau Pathology Using Dynamic Contrast-Enhanced MRI Poster presentation, Saturday, July 15, 12:15PM – 1:30PM. Presenting author: O Ismail
• The Coalition Against Major Diseases: Towards U.S. FDA Qualification of Hippocampal Volume As a Biomarker for Enrichment in Clinical Trials for Pre-Dementia Stages of Alzheimer's Disease Poster presentation, Wednesday, July 19, 9:30AM – 4:15PM. Presenting author: D Conrado
• Regulated Release of HYPER-Phosphorylated, Aggregated and Seeding Competent Tau from BRAIN Rodent and Human Synaptosomes Oral presentation, Sunday, July 16, 3:00PM – 3:15PM. Presenting author: E Sher
• Plasma Total Tau, Cognitive Decline, and Risk of Mild Cognitive Impairment in the Mayo Clinic Study on Aging Poster presentation, Tuesday, July 18, 9:30AM – 4:15PM. Presenting author: M Mielke
• Characterisation of Molecular Mechanisms That Are Triggered and Contribute to Tau Pathology in a Cell Model of Tau Aggregation Poster presentation, Wednesday, July 19, 9:30AM – 4:15PM. Presenting author: J Wolak
• fMRI of Visual Stimuli in a Tau Model of Alzheimer's Disease Poster presentation, Wednesday, July 19, 9:30AM – 4:15PM. Presenting author: I Harrison
• In Vivo Two-Photon Imaging of the Effects of Tauopathy and Amyloidopathy on Synapses Poster presentation, Tuesday, July 18, 9:30AM – 4:15PM. Presenting author: J Jackson
• Developing In Vivo models of Tau Propagation Which Are Relevant to Human Disease Pathogenesis and Applicable to Pre-Clinical Drug Discovery Oral presentation, Tuesday, July 18, 2:15PM – 2:30PM. Presenting author: Z Ahmed
• An Academic-Private Partnership for the Validation of New Models to Understand Tau-Related Hyperexcitability & Aggregation Using Human Induced Pluripotent Stem Cells Poster presentation, Tuesday, July 18, 9:30AM – 4:15PM. Presenting author: AC Socorro
• Characterization of Biofluid sTREM2 Using a Novel sTREM2 Assay Poster presentation, Wednesday, July 19, 9:30AM – 4:15PM. Presenting author: H Wang
• Assessing TREM2 Function in Alzheimer's Disease with RNA-Seq Oral presentation, Monday, July 17, 5:30PM – 5:45PM. Presenting author: G Carbajosa

Tau Deposit Ab Modulator Data

• Aggregate-Selective Anti-Tau Antibody MC-1 Demonstrated Robust in Vitro and In Vivo Activity to Neutralize Transmissible Tau and Reduce Tau Pathology Oral presentation, Monday, July 17, 5:00PM – 5:15PM. Presenting author: M Hayashi
• Preclinical Characterization of an Antibody [LY3303560] Targeting Aggregated Tau Oral presentation, Monday, July 17, 5:15PM – 5:30PM. Presenting author: R Alam
• Preclinical in Vitro and In Vivo Characterization of Tau Antibodies to Block Tau Propagation Poster presentation, Wednesday, July 19, 9:30AM – 4:15PM. Presenting author: S Wu

FabPEG Data

• Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Subjects of Single Doses of LY2599666, an Antigen Binding Fragment (Fab) of a Monoclonal Antibody That Targets Soluble Monomer Aβ Linked to a Poly(ethylene glycol) Molecule Poster presentation, Sunday, July 16, 9:30AM – 4:15PM. Presenting author: AM Hake

Flortaucipir Data

• A Robust, Simplified Braak-Type Classification Scheme for Flortaucipir F 18 Tau PET Images Oral presentation, Saturday, July 15, 9:45AM – 10:00AM. Presenting author: AJ Schwarz
• The Association of Tau Burden in Cerebral Lobes and Functional Brain Networks with Performance in Different Cognitive Domains Poster presentation, Wednesday, July 19, 9:30AM – 4:15PM. Presenting author: A Charil
• Comparison of Regional Flortaucipir PET to Quantitative Tau and Amyloid Immunoassay in Patients with Alzheimer's Disease Pathology: A Pilot Clinico-Pathological Study Poster  presentation, Monday, July 17, 9:30AM – 4:15PM. Presenting author: AD Siderowf
• An Update on the Binding Profile of Flortaucipir in AD Versus Normal CNS Proteins and Normal Brain Oral presentation, Sunday, July 16, 3:15PM – 3:30PM. Presenting author: G Attardo 
• Parametric Imaging of Tau Load in Alzheimer's Patients and Controls Using Flortaucipir Poster presentation, Saturday, July 15, 12:15PM – 1:30PM. Presenting author: EE Wolters
• Pathology in the Early Alzheimer's Prodome: Self and Informant Cognitive Concerns Show Different Patterns of Association with Tau Deposition on [18f]Flortaucipir PET in Amyloid Positive Older Adults Poster presentation, Saturday, July 15, 12:15PM –1:30PM. Presenting author: S Risacher
• PET Biomarkers in the EXPEDITION 3 Trial of Patients with Mild AD Oral presentation, Thursday, July 20, 8:30AM – 8:45AM. Presenting author: MA Mintun
• Modeling of Tau Trajectories across the Alzheimer's Disease Spectrum Using [18F]-Flortaucipir PET Imaging Poster presentation, Wednesday, July 19, 9:30AM – 4:15PM. Presenting author: S Shcherbinin

General Alzheimer's Disease Data

• Intermediate Changes in Cognition Predict Long Term Outcomes in Mild Alzheimer's Disease Dementia Poster presentation, Monday, July 17, 9:30AM – 4:15PM. Presenting author: C Reed
• Is the Annual Wellness Visit Adequate to Impact Cognitive Care? Poster presentation, Tuesday, July 18, 9:30AM – 4:15PM. Presenting author: N Fowler

Selective AB 1-42 Antibody Data

• Preclinical Discovery and Development of MEDI1814, a Monoclonal Antibody Selectively Targeting Beta-Amyloid 42 (Aβ42) Poster presentation, Sunday, July 16, 9:30AM – 4:15PM. Presenting author: A Billinton
• MEDI1814, a High-Affinity Antibody Directed to the C-Terminus of Aßx-42, Abrogates Synaptic Plasticity Disruption Caused By Synthetic or AD Brain-Derived Aß Soluble Assemblies In Vivo Poster presentation, Tuesday, July 18, 9:30AM – 4:15PM. Presenting author: T Ondrejcak
• Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEDI1814, a beta-Amyloid 42 (ab42)-Specific Antibody, in Patients with Mild-Moderate Alzheimer's Disease Oral presentation, Monday, July 17, 2:15PM – 2:30PM. Presenting author: T Ostenfeld

About Alzheimer's Disease
Alzheimer's disease is a fatal illness that causes progressive decline in memory and other aspects of cognition. Dementia due to Alzheimer's is the most common form of dementia, accounting for 60 to 80 percent of all cases.^i,ii There are currently an estimated 47 million people living with dementia around the world,ⁱⁱⁱ with numbers expected to increase to nearly 75 million by 2030 and 132 million by 2050.^iv  Almost 10 million new cases of dementia are diagnosed each year worldwide, implying one new case every 3.2 seconds.^v The current annual societal and economic cost of dementia is estimated at more than $800 billion and it is expected to become a trillion dollar disease by 2018.^vi

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring 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 true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels. P-LLY    

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about investigational treatments and diagnostics for Alzheimer's disease and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that these investigational compounds or diagnostics will achieve primary study endpoints or receive regulatory approvals.  For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

ⁱ Alzheimer's Disease International. Dementia statistics. http://www.alz.co.uk/research/statistics. Accessed March 2017.

ⁱⁱ Alzheimer's Association. What Is Dementia? http://www.alz.org/what-is-dementia.asp. Accessed March 2017.

ⁱⁱⁱ Alzheimer's Disease International. Dementia statistics. http://www.alz.co.uk/research/statistics. Accessed March 2017.

^iv Alzheimer's Disease International. Dementia statistics. http://www.alz.co.uk/research/statistics. Accessed March 2017.

^v Alzheimer's Disease International. Dementia statistics. http://www.alz.co.uk/research/statistics. Accessed March 2017.

^vi Alzheimer's Disease International. World Alzheimer Report 2015 The Global Impact of Dementia. https://www.alz.co.uk/research/WorldAlzheimerReport2015.pdf. Accessed March 2017.

 

 

Refer to:
Media – Courtney Kasinger; ckasinger@lilly.com; 317.501.7056 (Lilly)
Investors – Phil Johnson; johnson_philip_l@lilly.com; 317.655.6874 (Lilly)

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