Acumen Pharmaceuticals (ABOS) - Alzheimer’s disease (AD) Phase 1 top-line data due in 3Q 2023

Disclaimer: This is a lottery ticket play, expect to lose your money.

Acumen (ABOS) is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are primary triggers of Alzheimer’s disease pathology.


Acumen is currently focused on advancing its investigational product candidate, ACU193, a humanized monoclonal antibody that selectively targets toxic soluble AβOs in INTERCEPT-AD, a Phase 1 clinical trial involving early Alzheimer’s disease patients. The Anti-Amyloid-ß Oligomer Antibody ACU193 Gained FDA Fast Track Designation as well.

Upcoming Catalyst: Phase 1 top-line data due in 3Q 2023

  • INTERCEPT-AD: Phase 1 clinical trial of ACU193 in patients with early Alzheimer’s disease (AD) (RCT)

  • Topline results, safety and clinical proof-of-mechanism following full database lock expected in Q3 2023

  • The Phase 1 INTERCEPT-AD trial enrolled 65 subjects across 17 active sites in the United States

  • The INTERCEPT-AD study consists of single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts and is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and target engagement of intravenous doses of ACU193:

  • INTERCEPT-AD a Randomized Placebo Controlled Phase 1 in Early AD patients*:

  • Anticipate next clinical study, with success in Phase 1, starting as Phase 2 study
    with potential to expand to Phase 3 registration study based on interim expansion

*on January 30, 2023, Acumen submitted a protocol amendment to FDA to reduce the dose in Cohort 7 to 25 mg/kg Q2W from 60 mg/kg Q2W. This was based on a blinded review of
preliminary pharmacokinetic data, inclusive of plasma and CSF levels, that indicate a dose of 60 mg/kg Q2W should not be needed to attain central target engagement, and preliminary
safety data, inclusive of two asymptomatic cases of ARIA-E. While ACU193 is early in clinical development, the incidence of ARIA-E to date is consistent with our previous expectations
regarding the safety profile of ACU193. The dose of ACU193 in Cohort 6 (60 mg/kg Q4W) has been maintained as planned.

Extensive Pre-Clinical Data Package supported the continued development:

Acumen is Well Capitalized (~$200M) with Expected Cash Runway Through 2025

Position: Some lottery tickets


Thank you @Fllwoman who helped to frame this.

  • INTERCEPT-AD completed enrollment in February 2023
  • Topline data expected in the third quarter of 2023
  • Cash, cash equivalents and marketable securities of $193.4 million as of Dec. 31, 2022 expected to be sufficient to support clinical and operational goals through 2025

ABOS is running a bit yesterday and today in sympathy of the following

  • Topline results for ACU193, the first clinical stage amyloid beta oligomer (A βO)-directed antibody, to provide deeper insight into candidate’s therapeutic potential for the treatment of early Alzheimer’s disease
  • Phase 1 INTERCEPT-AD data investigating safety, pharmacokinetics and target engagement of ACU193 to be included in a Featured Research Session as a Developing Topics oral presentation on July 16