Slide 1: ALTITUDE-AD: Use of a Validated Plasma pTau217 Assay to Screen Potential Participants
ALTITUDE-AD: Use of a Validated Plasma pTau217 Assay to Screen Potential Participants in an Ongoing Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Sabirnetug for Early Alzheimer's Disease Todd Feaster, PsyD Acumen Pharmaceuticals
Slide 2: Disclosure
Disclosure • Dr. Feaster is an employee shareholder at Acumen Pharmaceuticals
Slide 3: Sabirnetug in Early AD Clinical Trials
Sabirnetug in Early AD Clinical Trials • Sabirnetug Presentation Alert • Humanized monoclonal IgG2 antibody Wed. 11:45-12:45; P12, #3-003 • Highly selective for amyloid beta oligomers (AβOs) INTERCEPT-AD Biomarker Results: Early • Clinical effect on synaptic biomarkers consistent with proposed effec
Slide 4: ALTITUDE-AD: Phase 2 Study Design of Sabirnetug for Early AD
ALTITUDE-AD: Phase 2 Study Design of Sabirnetug for Early AD 542 participants randomized 1:1:1 OLE* Follow-up (up to 52 Weeks) (70 Days after Screening Double Blind Treatment Period Last dose) (120 days) (80 weeks) Follow-up (70 Days after Last dose) Sabirnetug 35 mg/kg Q4W * At Week 80, participant
Slide 5: AD Trials Often Have High Percentages of Negative Amyloid PET During Screening
AD Trials Often Have High Percentages of Negative Amyloid PET During Screening 5
Slide 6: In ALTITUDE-AD, We Aim to Reduce PET/LP Burden by Screening for pTau217
In ALTITUDE-AD, We Aim to Reduce PET/LP Burden by Screening for pTau217 • Plasma concentrations of pTau217 are highly predictive for AD1 • pTau217 is being used in North America as an enrichment strategy to help identify potential participants with a high likelihood of meeting amyloid inclusion crit
Slide 7: ALTITUDE-AD: Two-Part Screening Process
ALTITUDE-AD: Two-Part Screening Process 7
Slide 8: pTau217 Screening Results
pTau217 Screening Results North America (US and Canada) Study Data • UK and EU sites did not use pTau217 as a screening enrichment strategy 8
Slide 9: Amyloid Status for Participants With pTau217 ≥0.15 pg/mL
Amyloid Status for Participants With pTau217 ≥0.15 pg/mL • Graph shows the Participants with pTau217 ≥0.15 pg/mL percentage of participants and Known Amyloid Status, % included or excluded from the study based on amyloid status after a positive pTau217 result • Bin width represents a pTau217 range o
Slide 10: pTau217 Enrichment Strategy Reduced Amyloid PET Screen Failure Rates
pTau217 Enrichment Strategy Reduced Amyloid PET Screen Failure Rates Final Data (US study) Preliminary Global Data 10
Slide 11: Summary
Summary The pTau217 enrichment strategy in North America performed as intended • Improved amyloid positive screen rates • 81% of the participants who proceeded to PET or CSF were enriched for meeting amyloid-based inclusion criteria • Significant improvement from INTERCEPT-AD where 40% of participan
Slide 12: Thank you!
Acknowledgments • The authors are grateful to the study participants and their study partners, as well as the study investigators and staff, all of whom make the ALTITUDE-AD clinical trial possible Thank you! Scan for additional publications 12