ACU193
Our mission is to develop the right antibody for the right target and in the right amount – ultimately producing a more pronounced and clinically active treatment option for Alzheimer’s disease patients. Enter ACU193.
ACU193, our lead therapeutic candidate, is an anti-amyloid-beta oligomer (AβO) monoclonal antibody (mAb) with best-in-class potential for efficacy and safety in Alzheimer’s disease. It has been designed to have disease-modifying benefits with an improved safety profile, while also potentially providing symptomatic benefit for Alzheimer’s patients.
ACU193 is the first immunotherapy drug candidate to enter the clinic that was developed to target toxic AβOs: early and persistent drivers of Alzheimer’s-associated pathology and neurodegeneration. ACU193 addresses an underlying cause of Alzheimer’s by preventing toxic AβOs from binding to dendritic spines and helping preserve neuronal function. To learn more about AβOs, please visit our Science page.
ACU193 is differentiated from other anti-Aβ mAbs:
- Highly selective for oligomers, the toxic AβO species, relative to other anti-Aβ mAbs that are less selective and/or target different amyloid species, such as monomers or plaques
- Designed to provide improved clinical efficacy with low risk of ARIA (amyloid-related imaging abnormalities)
- Potential for cognitive improvement in addition to disease slowing
State 1
ACU193 antibody prevents toxic AβOs from binding to dendritic spines thereby preserving neural function
State 2
AβOs are a primary trigger and persistent driver of Alzheimer’s-associated pathology and neurodegeneration.
History of ACU193
ACU193 is the result of an eight-year research collaboration between Acumen and Merck, for which we hold its exclusive rights. Under the Acumen team’s stewardship, we further continued to profile in vivo activity and developability of ACU193. In 2017, the National Institute of Aging awarded a competitive $3.6 million U01 grant to Acumen for preclinical and early clinical development of ACU193.
Clinical Development of ACU193
In 2021, Acumen initiated INTERCEPT-AD, a first-in-human, Phase 1 clinical trial of ACU193 in early Alzheimer’s patients. We are currently planning a Phase 2/3 trial. We anticipate ACU193 to provide early-stage Alzheimer’s patients with clinically meaningful slowing of cognitive decline with an acceptable safety profile.
Expanded Access Policy
Clinical trials, and the subsequent approval of a therapy, provide the best way to provide long-term access to new therapies to as many patients as possible. Outside of participation in one of its clinical trials, Acumen Pharmaceuticals does not currently accept or grant requests for expanded access to any of its investigational drugs. Patients interested in an investigational drug which has not yet been approved are encouraged to speak with their doctor and potentially participate in one of Acumen’s clinical trials. To learn more about Acumen’s ongoing clinical programs, please see the ACU193 or INTERCEPT-AD Trial webpages on this website. Information on Acumen’s clinical trials can also be found at www.clinicaltrials.gov.
Applicability:
This Expanded Access Policy applies generally to all investigational drugs manufactured or distributed by Acumen for use in serious diseases or conditions. At such time as Acumen begins to make expanded access to any of our investigational drugs available, this website and policy will be updated to notify the public of the procedures for making expanded access requests and our criteria for evaluating such requests.
Questions:
Patients and families interested in learning more about expanded access generally can visit the Expanded Access Navigator (https://navigator.reaganudall.org/). Additional questions may be directed to clinicaltrials@acumenpharm.com. Acumen typically responds to inquiries about our Expanded Access Policy within two (2) business days.