Slide 1: ALTITUDE-AD: Use of a pTau217 Assay as a Marker of Amyloid Burden
ALTITUDE-AD: Use of a pTau217 Assay as a Marker of Amyloid Burden for Screening Participants in an Ongoing Phase 2 Study of Sabirnetug in Early Alzheimer's Disease Todd Feaster, PsyD Acumen Pharmaceuticals 1
Slide 2: Disclosure
Disclosure • Dr. Feaster is an employee shareholder at Acumen Pharmaceuticals 2
Slide 3: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and
Slide 4: Sabirnetug in Early AD Clinical Trials
Sabirnetug in Early AD Clinical Trials • Sabirnetug • Humanized monoclonal IgG2 antibody • Highly selective for amyloid beta oligomers (AβOs) • Clinical effect on synaptic biomarkers consistent with proposed mechanism of targeting AβOs1 • INTERCEPT-AD Phase 1 clinical trial (completed) • US study in
Slide 5: ALTITUDE-AD: Phase 2 Study Design of Sabirnetug for Early AD
ALTITUDE-AD: Phase 2 Study Design of Sabirnetug for Early AD 540 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 6: AD Trials Often Have High Percentages of Negative PET During Screening
AD Trials Often Have High Percentages of Negative PET During Screening PET (60%) 6
Slide 7: 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 as an enrichment strategy to help identify potential participants with a high likelihood of meeting amyloid inclusion criteria on PET or CS
Slide 8: ALTITUDE-AD: Two-Part Screening Process
ALTITUDE-AD: Two-Part Screening Process 8
Slide 9: pTau217 Screening Results
pTau217 Screening Results North America (US and Canada) Study Data • UK and EU sites are not using pTau217 as a screening enrichment strategy (not CE marked) 9
Slide 10: Amyloid Status for Participants With pTau217 ≥0.15 pg/mL
Amyloid Status for Participants With pTau217 ≥0.15 pg/mL Participants with pTau217 ≥0.15 pg/mL • Graph shows the percentage and Known Amyloid Status, % of participants included or excluded from the study based on amyloid status after a positive pTau217 result • Bin width represents a pTau217 range o
Slide 11: History of Amyloid Can be Used to Bypass Screening pTau217
History of Amyloid Can be Used to Bypass Screening pTau217 • May use outside evidence of amyloid positivity in place of pTau217 • Examples include historical PET or CSF Aβ42/40 ratio and must be approved by medical monitor • Upon approval, the participant will skip the blood draw for pTau217 and mov
Slide 12: Summary
Summary The pTau217 enrichment strategy is performing as intended • Improving amyloid positive screen rates • 78% of the participants who proceed to PET or CSF are enriched for meeting amyloid-based inclusion criteria • Significant improvement from INTERCEPT-AD where 40% of participants were amyloid
Slide 13: Acknowledgments
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 13
Slide 14: Thank you!
Thank you!