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 Symptomatic Alzheimer's Disease Eric Siemers MD Acumen Pharmaceuticals AD/PD 2025, Vienna 1April 2025
Slide 2: Disclosure
Disclosure • Dr. Siemers is an employee and shareholder at Acumen Pharmaceuticals
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 (ACU193) Overview
Sabirnetug (ACU193) Overview • Sabirnetug • Humanized monoclonal IgG2 antibody • Highly selective for globular amyloid beta oligomers (AβOs) • Clinical effect on synaptic biomarkers consistent with proposed mechanism of targeting AβOs2 • INTERCEPT-AD Phase 1 clinical trial (NCT04931459, completed)1,
Slide 5: 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 6: In ALTITUDE-AD, Screening with Plasma pTau217 was Introduced to Reduce PET/LP Burden
In ALTITUDE-AD, Screening with Plasma pTau217 was Introduced to Reduce PET/LP Burden • Plasma concentrations of pTau217 are highly predictive for amyloid pathology1 • pTau217 is being used as an enrichment strategy to help identify potential participants with a high likelihood of meeting amyloid inc
Slide 7: ALTITUDE-AD: Two-Part Screening Process
ALTITUDE-AD: Two-Part Screening Process (preliminary data shown for US and Canada only) Screening Part 1a N=1890 Medical history/con meds/MMSE (22-30) N= 268 (14%) excluded Plasma pTau217 obtained Screening Part 1b N=1622 N= 783 (48%) excluded Plasma pTau217 >=0.15 pg/mL Screening Part 2 N=839 Top r
Slide 8: Amyloid Status for Participants with Plasma pTau217 ≥ 0.15 pg/mL
Amyloid Status for Participants with Plasma pTau217 ≥ 0.15 pg/mL • Graph shows the percentage of participants included • Graph shows the proportion of participants with or excluded from the study based on amyloid status positive PET or CSF after a positive pTau217 result after a positive pTau217 res
Slide 9: Screening with Plasma pTau217 Greatly Reduced Screen Failure due to Amyloid PET
Screening with Plasma pTau217 Greatly Reduced Screen Failure due to Amyloid PET Final US data Preliminary global data 9
Slide 10: Summary
Summary The pTau217 enrichment strategy performed as intended • Improved amyloid positive screen rates • 81% of the participants who proceed to PET or CSF are positive for meeting amyloid-based inclusion criteria • Significant improvement from INTERCEPT-AD where only 40% of participants were amyloid
Slide 11: 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 11
Slide 12: Thank you!
Thank you!