BioArctic AB Class B · OMXSTO:BIOA_B
BioArctic AB Class B — Clinical Trials on Alzheimer's Disease (CTAD) 2022
74 slides from BioArctic AB Class B's conference presentation, Dec 2, 2022
Slide 1: 2022 Clarity AD CTAD Presentations
2022 Clarity AD CTAD Presentations Clarity AD: A Phase 3 Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study Evaluating Lecanemab in Early Alzheimer's Disease Clinical Trials on Alzheimer’s Disease (CTAD) San Francisco, CA, USA November 29 – December 2, 2022
Slide 2: Welcome and Introductions
Welcome and Introductions Takeshi Iwatsubo University of Tokyo
Slide 3: CTAD 2022 Clarity AD Session Agenda
Clarity AD Topline Results Presentations CTAD 2022 Clarity AD Session Agenda CTAD 2022 Session Agenda: Clarity AD: A Phase 3 Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study Evaluating Lecanemab in Early Alzheimer's Disease TIME SESSION PRESENTERS 5 min Welcome & Introductions Takesh
Slide 4: Trial of Lecanemab in Early Alzheimer's Disease (NEJM)
<>) tt NEW ENGLAND <2) JOURNAL of MEDICINE ORIGINAL ARTICLE Trial of Lecanemab in Early Alzheimer’s Disease Christopher H. van Dyck, M.D., Chad J. Swanson, Ph.D., Paul Aisen, M.D., Randall Bateman, M.D., Christopher Chen, B.M., 8.Ch., Michelle Gee, Ph.D., Michio Kanekiyo, M.S., David Li, Ph.D., Lari
Slide 5: Clarity AD: Clinical Trial Background and Study Design Overview
Clarity AD: Clinical Trial Background and Study Design Overview Michael Irizarry Eisai Inc. Acknowledgements Participants & Their Support We acknowledge with thanks the individuals who enrolled in lecanemab Clarity AD Trial as well as their family, caregivers, and friends who supported them. Data Sa
Slide 6: Disclosure
Disclosure • Dr. Irizarry is an employee of Eisai Inc. 6
Slide 7: Lecanemab: Unique Selectivity Towards Toxic Soluble Species of Aβ
Lecanemab: Unique Selectivity Towards Toxic Soluble Species of Aβ Highest Preference for Soluble Protofibrils/Oligomers Versus Monomeric and Fibrillar Forms of Aβ Neurotoxic forms Monomers Oligomers Protofibrils Fibrils 9 – 75 kDa >75 – 5000 kDa Soluble Insoluble Lecanemab binding profile (Darker co
Slide 8: Alzheimer's Disease Continuum & Lecanemab Clinical Trials
Alzheimer’s Disease Continuum & Lecanemab Clinical Trials Study 201 AHEAD 3-45 Study Clarity AD A3 A45 DIAN-TU High risk Preclinical AD MCI* Mild AD Moderate Severe Adapted from Lancet Neurol. 2013 Feb;12(2):207-16. Cognition unimpaired Very mild Symptoms Symptoms Symptoms symptoms. Interfere with I
Slide 9: Lecanemab Phase 2b Study
Lecanemab Phase 2b Study Results Enabled Optimization of Design of Clarity AD Study 201 (Phase 2b) Clarity AD (Phase 3) Bayesian Adaptive Randomization Design and Dose Study Global, Placebo-Controlled, Double-blind, Randomized Regimen-finding Study with OLE Design 854 Randomized Trial with OLE MCI d
Slide 10: Clarity AD Study Design
Clarity AD Study Design Randomization stratified according to: Diverse patient population Optional longitudinal sub-studies • Clinical subgroup (MCI due to AD or mild AD dementia) • Eligibility Criteria • Amyloid burden (amyloid PET; n=716) • Presence or absence of ongoing approved AD treatment • Si
Slide 11: Sample Size Calculation & Statistical Testing Hierarchy
Sample Size Calculation & Statistical Testing Hierarchy Sample Size Determination for CDR-SB Statistical Testing Hierarchy • Estimated standard deviation for placebo: 2.031 1. CDR-SB change from baseline at 18 months – Increases across any of the six CDR domains scores (which range from 0, 0.5, 1, 2
Slide 12: Study Conduct: Safety
Study Conduct: Safety • Safety monitored throughout the study in a blinded manner by the sponsor and in an unblinded manner by an independent data safety monitoring committee ARIA Management – Safety evaluations included monitoring of vital signs, physical examinations, adverse events, clinical labo
Slide 13: Subject Disposition and Analyses Populations
Clarity AD Subject Disposition and Analyses Populations 13
Slide 14: Clarity AD Baseline Characteristics
Clarity AD Baseline Characteristics Demographic Characteristics Combined Total United States Characteristic N=1795 N=948 Age, median (range), years 72 (50, 90) 73(50,90) Age Group, n (%) <65 years 353 (19.7) 158 (16.7) ≥65 to <80 1203 (67.0) 637 (67.2) ≥80 239 (13.3) 153 (16.1) Female , n (%) 938 (5
Slide 15: Clarity AD Baseline Characteristics: Comorbidities and Comedications
Clarity AD Baseline Characteristics Comorbidities and Comedications Combined Total United States Characteristic N=1795 N=948 Comorbidities Hypertension, n (%) 993 (55.3%) 612 (64.6%) Hyperlipidemia, n (%) 1085 (60.4%) 674 (71.1%) Ischemic Heart Disease, n (%) 291 (16.2%) 189 (19.9%) Diabetes, n (%)
Slide 16: Clarity AD Baseline Characteristics: Clinical
Clarity AD Baseline Characteristics Clinical Characteristics Lecanemab Placebo 10 mg/kg biweekly (N=875) (N=859) Age, mean (standard deviation), years 71.0 (7.8) 71.4 (7.9) Female, n (%) 464 (53.0) 443 (51.6) Caucasian 677 (77.4) 655 (76.3) Years since diagnosis 1.17 (1.537) 1.25 (1.506) Years since
Slide 17: Summary
Summary • The lecanemab phase 2b proof-of-concept study provided a robust framework to optimally design the confirmatory phase 3 study Clarity AD • Clarity AD is intended to be a definitive Phase 3 study to confirm efficacy and safety – Simple randomized, double-blind, parallel group design without
Slide 18: Acknowledgements
Acknowledgements Site Investigators Australia: Bruce Brew (St Vincent's Hospital - Translational Research Centre); Roger Clarnette (Australian Alzheimer's Research Foundation); Stephen Macfarlane (HammondCare Malvern Clinical Trials Unit); Ranjeev Chrysanth Pulle (The Prince Charles Hospital/Interna
Slide 19: Acknowledgements
Acknowledgements Site Investigators Japan: Sadao Katayama, (Rijikai Medical Corporation Katayama Medical Clinic); Yoshiaki Aihara, (Shinozuka Hospital); Sadahisa Tokuda, (Sapporo Teishinkai Hospital); Akiko Yamazaki, (NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL); Noriko Kawashima, (Kawashima Neuro
Slide 20: Acknowledgements
Acknowledgements Site Investigators United States: David Watson, (Alzheimer's Research and Treatment Center); Orlando Maldonado-Robles, (Bradenton Research Center, Inc. ); Jonathan Liss, (Columbus Memory Center); Marshall Nash, (NeuroStudies.net, LLC); Marc Agronin, (Miami Jewish Health Systems); Gr
Slide 21: Topline Efficacy Results from Clarity AD
Lecanemab for the Treatment of Early Alzheimer’s Disease: Topline Efficacy Results from Clarity AD Christopher van Dyck Yale School of Medicine
Slide 22: Christopher van Dyck - Disclosures
Christopher van Dyck - Disclosures Advisor/Consultant for: Roche Pharmaceuticals Eisai, Inc Ono Pharmaceuticals Cerevel Yale University and Dr. van Dyck receive grant support from: Eli Lilly Janssen Pharmaceuticals Biogen Idec Eisai, Inc Roche Pharmaceuticals Genentech, Inc Biohaven Pharmaceuticals
Slide 23: Clarity AD: Topline Efficacy Endpoints
Clarity AD: Topline Efficacy Endpoints Primary Endpoint Key Secondary Endpoints • Change from baseline at Key secondary endpoints 18 months in CDR-SB include change from baseline at 18 months in: • Amyloid PET • ADAS-Cog14 • ADCOMS • ADCS MCI-ADL ADAS-Cog14, Alzheimer’s Disease Assessment Scale–cogn
Slide 24: Statistically Significant Results for Primary & Key Secondary Endpoints
Statistically Significant Results for Primary & Key Secondary Endpoints Lecanemab vs Placebo Primary efficacy endpoint CDR-SB Change from baseline to 18 months Difference in least square mean -0.451 95% CI of the least square mean -0.669, -0.233 P value vs placebo 0.00005 Key secondary efficacy endp
Slide 25: Clarity AD Primary Endpoint: CDR-SB
Clarity AD Primary Endpoint: CDR-SB Lecanemab Significantly Slowed Disease Progression on CDR-SB by 27% at 18 Months and at All Time Points Beginning at 6 Months Adjusted Mean Change from Baseline (±SE) in CDR-SB Note: Based on modified intention-to-treat analysis population. Adjusted mean change fr
Slide 26: Amyloid PET
Amyloid PET: Lecanemab Significantly Reduced Fibrillar Amyloid Burden at All Time Points Beginning at 3 Months Mean <30 Less Amyloid Centiloids for lecanemab at 18 months* Difference of -59.1 Centiloids at 18 months ** ** *After 18 months of treatment, the average amyloid level was 23 Centiloids in
Slide 27: ADAS-Cog14
ADAS-Cog14: Lecanemab Significantly Slowed Disease Progression on ADAS-Cog14 by 26% at 18 Months and at All Time Points Beginning at 6 Months ** Note: Based on modified intention-to-treat analysis population. Adjusted mean change from baseline, SE and p-value are derived using mixed model repeat mea
Slide 28: ADCOMS
ADCOMS: Lecanemab Significantly Slowed Disease Progression on ADCOMS by 24% at 18 Months and at All Time Points Beginning at 6 Months Note: Based on modified intention-to-treat analysis population. Adjusted mean change from baseline, SE and p-value are derived using mixed model repeat measures (MMRM
Slide 29: ADCS MCI-ADL
ADCS MCI-ADL: Lecanemab Significantly Slowed Disease Progression on ADCS MCI-ADL by 37% at 18 Months and at All Time Points Beginning at 6 Months Note: Based on modified intention-to-treat analysis population. Adjusted mean change from baseline, SE and p-value are derived using mixed model repeat me
Slide 30: Results of CDR-SB Sensitivity Analyses
Results of CDR-SB Sensitivity Analyses Results are Robust Across Pre-Specified Sensitivity Analyses Adjusted mean Adjusted mean change from change from Treatment Type of Sensitivity Analysis baseline at 18 baseline at 18 difference at % Slowing P-value months for placebo months for 18 months group l
Slide 31: Clarity AD Subgroup Analyses: CDR-SB
Clarity AD Subgroup Analyses: CDR-SB Consistent Results Across Randomization Strata 31 AD, Alzheimer’s disease; ApoE4, apolipoprotein E4; CDR-SB, Clinical Dementia Rating-sum of boxes; CI, confidence interval; MCI, mild cognitive impairment.
Slide 32: Subgroup Analyses: ADAS-Cog14 & ADCS MCI-ADL
Clarity AD Subgroup Analyses: ADAS-Cog14 & ADCS MCI-ADL Consistent Results Across Randomization Strata ADAS-Cog14 ADCS MCI-ADL AD, Alzheimer's disease; ADAS-Cog14, Alzheimer’s Disease Assessment Scale-Cognitive Subscale; ADCS MCI-ADL, Alzheimer's Disease Cooperative Study-Activities of Daily Living
Slide 33: Clarity AD Subgroup Analyses: CDR-SB
Clarity AD Subgroup Analyses: CDR-SB Consistent Results Across Other Subgroups of Interest 33 ApoE4, apolipoprotein E4; CDR-SB, Clinical Dementia Rating-sum of boxes; CI, confidence interval.
Slide 34: Subgroup Analyses: ADAS-Cog14 & ADCS MCI-ADL
Clarity AD Subgroup Analyses: ADAS-Cog14 & ADCS MCI-ADL Consistent Results Across Other Subgroups of Interest ADAS-Cog14 ADCS MCI-ADL 34 ADAS-Cog14, Alzheimer’s Disease Assessment Scale-Cognitive Subscale; ADCS MCI-ADL, Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale for Mild
Slide 35: Summary
Summary Clarity AD Met All Primary and Key Secondary Endpoints • Lecanemab treatment met the primary and secondary end points vs placebo at 18- months, with highly significant differences starting at six months (all P<0.001): – CDR-SB: reduced clinical decline by 27% (difference: -0.45; P value = 0.
Slide 36: Safety Profile of Lecanemab in Clarity AD
Safety Profile of Lecanemab in Clarity AD Marwan Sabbagh Barrow Neurological Institute 36
Slide 37: Disclosures
Disclosures • Dr Sabbagh has the following disclosures: – Ownership interest (Stock or stock options): NeuroTau, Optimal Cognitive Health Company, uMethod Health, Versanum, Athira, TransDermix, Seq BioMarque, NeuroReserve, Cortexyme/Quince Therapeutics, Lighthouse Pharmaceuticals, Alzheon – Consulti
Slide 38: Clarity AD: Safety Topline Endpoints
Clarity AD: Safety Topline Endpoints • Adverse Events • Laboratory Abnormalities • Vital Signs • ARIA-E and H • Infusion-related reactions • Safety was monitored throughout study by the data safety monitoring board (DSMB) and by an independent medical monitoring team ARIA-E, amyloid related imaging
Slide 39: Overall Adverse Event (AE) Summary
Overall Adverse Event (AE) Summary Core Study Placebo Lecanemab (n=897) (n=898) n (%) n (%) Deaths* 7 (0.8) 6 (0.7) Serious adverse event (SAE) 101 (11.3) 126 (14.0) SAE with ARIA-E 0 7 (0.8) SAE with ARIA-H 1 (0.1) 5 (0.6) SAE with infusion-related reactions 0 11 (1.2) SAE without ARIA or infusion-
Slide 40: Most Common Adverse Events
Most Common Adverse Events Placebo Lecanemab Adverse Events Of Special Interest (n=897) (n=898) (Pooled preferred terms [PTs]) % % Infusion-related reaction 7.4 26.4 ARIA-E 1.7 12.6 ARIA-H (pooled PTs) 9.0 17.3 • There were no significant Isolated ARIA-H (pooled PTs) 7.8 8.9 trends in mean changes o
Slide 41: Infusion-Related Reactions and Immunogenicity
Infusion-Related Reactions and Immunogenicity Infusion-Related Reactions Placebo Lecanemab Infusion-related reactions are limited in impact and do not recur in (n=897) (n=898) most subjects regardless of prophylaxis n (%) n (%) • Infusion-related reactions were largely mild-to-moderate (grade 1-2: 9
Slide 42: ARIA-E
ARIA-E Placebo Lecanemab (N=897) (N=898) • ARIA-E events were largely mild- n/N (%) n/N (%) to-moderate radiographically (91%) and asymptomatic (78%) ARIA-E 15/897 (1.7) 113/898 (12.6) ARIA-E by ApoE4 genotype • In the 2.8% of subjects with symptomatic ARIA-E, commonly ApoE4 noncarrier 1/286 (0.3) 1
Slide 43: Time to ARIA-E Events
Time to ARIA-E Events • ARIA-E with lecanemab generally occurred within the first 3 months of treatment (71%) and by 6 months (92%) • ARIA-E resolved within 4 months of detection (81%), regardless of ApoE4 carrier status – 60/111 (54%) resolved by 90 days – 90/111 (81%) resolved by 120 days 43 ApoE4
Slide 44: Lecanemab ARIA-E Events
Lecanemab ARIA-E Events: Radiographic and Clinical Severity Overall and by APOE4 Genotype • ARIA-E more common in ApoE4+ on treatment and placebo, with highest frequency in homozygotes • Mostly mild to moderate in radiographic and clinical severity, including homozygotes • Most subjects with mild ra
Slide 45: ARIA-H
ARIA-H • Isolated ARIA-H was similar between lecanemab (8.9%) and placebo (7.8%) with low rates of clinically symptomatic ARIA-H • Timing of isolated ARIA-H occurs randomly during treatment course, while ARIA-H that occurs with ARIA-E tended to occur early in the course of lecanemab treatment Total
Slide 46: Cerebral Macrohemorrhage in Lecanemab Studies
Cerebral Macrohemorrhage in Lecanemab Studies Data Cutoff October 22, 2022 for Open-Label Extension (OLE; Ongoing) Total Anticoagulant Use 1 Includes one non-treatment emergent case in Lecanemab Lecanemab placebo (event > 30 days after discontinuing study Study Placebo Placebo 10 mg/kg q2wk 10 mg/kg
Slide 47: Summary: Clarity AD Safety
Summary Clarity AD Safety • Lecanemab was generally well-tolerated – Most common adverse events were infusion-related reactions, ARIA-H, ARIA-E, and headache • ARIA incidence profile was within expectations, and the symptomatic ARIA rate was low – Incidence of ARIA-E: 12.6% for lecanemab and 1.7% pl
Slide 48: Imaging, Plasma, and CSF Biomarkers Assessments from Clarity AD
Imaging, Plasma, and CSF Biomarkers Assessments from Clarity AD Randall J. Bateman Washington University School of Medicine
Slide 49: Disclosures
Disclosures • Dr Bateman is the Director of DIAN–TU and Principal Investigator of DIAN–TU-001 • He receives research support from the NIA of the NIH, DIAN–TU trial pharmaceutical partners (Eli Lilly and Company, F. Hoffman-La Roche Ltd and Avid Radiopharmaceuticals), Alzheimer’s Association, GHR Fou
Slide 50: Biomarker Objectives in Lecanemab Development
Biomarker Objectives in Lecanemab Development Biomarkers hierarchy Assessment Purpose Hypothesis Patient Selection l Treatment of early AD prior to Amyloid PET Ø Confirm diagnosis in early AD advanced irreversible CSF Aβ42/40 Ø Select preclinical AD neurodegeneration plasma Aβ42/40 (AHEAD 3-45) popu
Slide 51: Clarity AD: Biomarker Assessments
Clarity AD: Biomarker Assessments All Prospectively Pre-specified in Statistical Analysis Plan CSF Plasma Imaging • Aβ[1-40]1 • Aβ 42/40 ratio4 • Amyloid PET5 • Aβ[1-42]1 • p-tau1813 • Tau PET (MK-6240) • t-tau1 • Glial fibrillary acidic protein • Volumetric MRI (vMRI; • p-tau1811 (GFAP)3 Whole brai
Slide 52: Amyloid Biomarkers
Amyloid Biomarkers CSF and Plasma Aβ42/40 Improves Indicating Early/Sustained Amyloid Reversal Effects CSF Aβ1-42 CSF Aβ42/40 Normalizes (↑) indicating improvement in Aβ aggregation process CSF Aβ1-40 Plasma Aβ42/40 Not affected 52 **** P<0.0001 Aβ, amyloid beta; CSF, cerebrospinal fluid, SE, standa
Slide 53: PET Centiloids and Amyloid PET SUVr Images
PET Centiloids and Amyloid PET SUVr Images at Baseline and 18 Months Highly Significantly Reduced Amyloid Plaque (Centiloids) at All Time Points; Mean at 18 Months of 23 Centiloids (Below 30 Centiloid Threshold of Positivity) Placebo Less Amyloid * * % Amyloid Negative (<30 CL) Placebo Lecanemab 15
Slide 54: Tau Biomarkers
Tau Biomarkers • CSF and plasma p-tau181 continued to increase in placebo group • CSF and plasma p-tau181 decreased in lecanemab group towards normal at all times measured • Indicates removing amyloid improves downstream tau phosphorylation at amyloid responsive 181 site CSF P-Tau181 Plasma P-Tau181
Slide 55: Tau PET
Tau PET Lecanemab Slows Tau Pathology in Temporal Lobe (Early Braak Regions)* Medial Temporal Meta Temporal Temporal *Other regions favored lecanemab but were p > 0.05 55 CI, confidence interval; PET, positron emission tomography; ROI, regions of interest.
Slide 56: Neurodegeneration Biomarkers
Neurodegeneration Biomarkers CSF NfL CSF T-Tau Plasma NfL • No difference in CSF NfL which had large variability • Plasma NfL, with larger sample size, trends towards difference (P=0.06) at 18 months • CSF-total tau increase in placebo and decreased in lecanemab treated group **** P<0.0001 56 CSF, c
Slide 57: Astrocytic and Synaptic Biomarkers
Astrocytic and Synaptic Biomarkers • GFAP, a marker of astrocyte activation and neurogranin and marker of synaptic dysfunction, both improved towards normal Plasma GFAP CSF Neurogranin 57 CSF, cerebrospinal fluid, GFAP: glial fibrillary acidic protein; SE, standard error. **** P<0.0001
Slide 58: Volumetric MRI: Atrophy in Brain and Hippocampi
Volumetric MRI: Increased Atrophy in Whole Brain and Cortical Thickness, with Decreased Atrophy in Hippocampi Whole brain volume Cortical thickness Lateral ventricular volume Increasing P<0.00001 P<0.00001 P<0.00001 Total hippocampal volume Left hippocampal volume Right hippocampal volume P=0.0039 P
Slide 59: Interpretation
Interpretation Lecanemab treatment impacted CSF, plasma, and imaging biomarkers across measures of amyloid, tau, neurodegeneration, astrocyte and synaptic pathophysiological measures. • Lecanemab had beneficial effects on biomarkers of amyloid, tau, and other pathophysiology measures • The neurodege
Slide 60: Clarity AD: Results in Context
Clarity AD: Results in Context Sharon Cohen, MD FRCPC Toronto Memory Program
Slide 61: Disclosures
Disclosures • Consultant (no personal fees) – Alnyalm, Biogen, Cogstate, Cognivue, Cassava Sciences, Eisai, Eli Lilly, INmuneBio, Novo Nordisk, ProMIS Neuroscience, RetiSpec, Roche • Research Grants (paid to institution only) – Agene Bio, Alector, Alnylam, Alzheon, Anavex, Biogen, Cassava Sciences,
Slide 62: Alzheimer's Disease – A Major Unmet Need of Our Time
Alzheimer’s Disease – A Major Unmet Need of Our Time • A chronic, progressive, disabling, and fatal disease1-7 • 6th leading cause of death in seniors3 Personality 3 • Accounts forDecreased 60-80% ofCommunication judgment cases of dementia challenges changes Unable to independently perform daily act
Slide 63: Important Treatment Goals in Alzheimer's Disease
Important Treatment Goals in Alzheimer’s Disease • Impact on symptoms • Greater magnitude of improvement • More sustained improvement duration • Slowing of disease • Maintaining or stabilizing abilities for longer periods • Delaying or preventing onset of more disabling and costly stages of disease
Slide 64: Disease Modification in Alzheimer's Disease
Disease Modification in Alzheimer’s Disease • FDA definition • Persistent effect on disease course • Direct effect on the underlying disease pathophysiology • EMA (CHMP) definition • Persistent delay in the underlying neuropathological process • Delay of clinical decline FDA Draft Guidance for Indus
Slide 65: Clarity AD Treatment Effect: CDR-SB
Clarity AD Treatment Effect: CDR-SB Global Measure of Cognition and Function Clarity AD % Slowing CDR-SB Lecanemab Effect • 27% slowing on CDR-SB • Increased magnitude of separation over time (0.45 at 18 months) • Effect seen across all CDR-SB domains CDR-SB Scale • Patient and caregiver interview •
Slide 66: Treatment Effect: Consistent Across Comorbidities and Anticoagulant Use
Treatment Effect: Consistent Across Comorbidities and Anticoagulant Use CDR-SB % Slowing 66 CDR-SB, Clinical Dementia Rating-Sum-of-Boxes ; CI, confidence interval.
Slide 67: Treatment Effect: Specific Scales of Cognition and Function
Treatment Effect: Specific Scales of Cognition and Function ADCS ADL-MCI ADAS-Cog14 • 26% slowing on ADAS-Cog14 at 18 months • 37% slowing on ADCS ADL-MCI at 18 months • Increases in magnitude of separation over time ADAS-Cog14 ADCS ADL-MCI • Administered to patient • Rated by family or caregiver •
Slide 68: Time to Worsening of Global CDR Scores
Time to Worsening of Global CDR Scores Time to Worsening of Global CDR Scores Rate of Progression to Next Stage • Hazard ratio 0.69 • 31% lower risk of converting to next stage of disease by global CDR • Individuals remain in earlier stages of Alzheimer’s disease for a longer period of time, even wi
Slide 69: Slope Analysis Using CDR-SB
Slope Analysis Using CDR-SB Observed Data and Extrapolation to 2 Years • 32% slowing of slope annually [(95%CI: 18% to 46%), p=0.00001] on lecanemab vs. placebo • Projected treatment difference at 25.5 months based on slope showed -0.68 treatment difference • Increasing separation over time between
Slide 70: Lifetime Health Outcomes: Trial Data Modeling Simulation
Lifetime Health Outcomes: Trial Data Modeling Simulation Lecanemab Could Delay AD Progression by Several Years Modeled early AD patient population1 based on lecanemab Study 201 and ADNI data3 Time to Advance to Mild, Moderate, and Severe AD Longer for Lecanemab SoC: MCI Mild AD Moderate AD Severe AD
Slide 71: Health-Related Quality of Life Measures
Health-Related Quality of Life Measures Slowing of Health Decline with Lecanemab on Subject and Study Partner Burden EQ-5D-5L (Subject) QOL-AD (Subject) 49% Less Decline 56% ** Less Decline ** Worsening Worsening • Consistent benefits seen in quality of life and caregiver burden across different sca
Slide 72: Summary
Summary • The convergence of evidence across multiple measures of cognition, function, disease progression, health-related quality of life, caregiver burden, and biomarkers, demonstrate that lecanemab treatment may offer meaningful benefits to patients, care partners, and society – Impact across cog
Slide 73: Panel Discussion and Q&A
Panel Discussion and Q&A Clarity AD
Slide 74: Thank you
Thank you Ne Clarity AD
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