Acumen Pharmaceuticals to Present Sabirnetug (ACU193) Fluid Biomarker and Target Engagement Analyses from Phase 1 INTERCEPT-AD Study in Early Alzheimer’s at the AD/PD™ 2024 Annual Meeting
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Insights
From a medical research perspective, the development of sabirnetug (ACU193) by Acumen Pharmaceuticals represents a significant stride in the therapeutic landscape of Alzheimer's disease (AD). The reported data from the Phase 1 INTERCEPT-AD trial indicates a promising safety profile and efficacy in targeting soluble amyloid beta oligomers (AβOs), which are implicated in the early stages of AD and are associated with synaptic dysfunction and neurodegeneration. The reduction of amyloid plaques and low levels of amyloid-related imaging abnormalities (ARIA-E) suggests a potential for sabirnetug to stand out among amyloid-directed therapies.
Furthermore, the drug's impact on cerebrospinal fluid (CSF) biomarkers, such as neurogranin and phosphorylated tau at threonine 181 (pTau181), is noteworthy. These biomarkers are crucial indicators of neuronal damage and tau pathology, respectively. The observed changes in CSF biomarker levels could provide insights into the drug's mechanism of action and its potential neuroprotective effects. The novel assay developed to measure target engagement in the CSF is an important tool for validating the drug's effect on its intended target, thus strengthening the scientific underpinnings of its clinical development.
Considering the market dynamics for Alzheimer's treatments, the entrance of sabirnetug into Phase 2 trials could have substantial implications for Acumen Pharmaceuticals and the broader market. Alzheimer's disease affects millions globally and the market for its treatments is expected to grow significantly. A therapy that differentiates itself with a favorable safety profile and effectiveness in reducing toxic AβOs could capture a significant market share. The acceptance of the nonproprietary name sabirnetug by the USAN and INN is also a critical step in the branding and commercialization process, signaling regulatory progress and market preparation.
Investors and stakeholders should pay close attention to the upcoming Phase 2 trial initiation, as positive results could drive investor confidence and potentially lead to partnerships or acquisition interest from larger pharmaceutical companies. However, it's important to note that AD drug development is notoriously challenging, with a high rate of clinical trial failures, which poses risks to Acumen's valuation and stock performance.
The announcement of Acumen Pharmaceuticals' progress with sabirnetug has implications for its financial health and investor perception. The transition from Phase 1 to Phase 2 trials is a critical juncture that often leads to increased R&D expenditures. However, successful trial outcomes can lead to increased investor interest, potential strategic partnerships and funding opportunities, which are crucial for a clinical-stage biopharmaceutical company.
Investors will likely scrutinize the upcoming presentations at the AD/PD conference, as the data disclosed could impact the company's stock price. It is essential to analyze the trial data in comparison to industry norms and competitor results. Exceptional safety and efficacy data could position Acumen favorably against competitors, potentially leading to an increased market capitalization and investment opportunities. Conversely, any negative developments could significantly impact the financial stability of the company.
- Oral presentation to explore drug effect of sabirnetug (ACU193) on key cerebrospinal fluid biomarkers in early AD
- Poster presentation to showcase method used to develop a first-of-its-kind assay to measure target engagement of an AβO-selective antibody
- On track to initiate a Phase 2 trial evaluating sabirnetug in the first half of 2024
- Sabirnetug is the nonproprietary name for ACU193 now accepted by the United States Adopted Name (USAN) Council and the International Nonproprietary Names (INN) Programme
CHARLOTTESVILLE, Va., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced that it will be presenting biomarker data and target engagement methods in an oral and poster presentation, respectively, at the upcoming International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD), taking place March 5-9, 2024, in Lisbon, Portugal, and online.
Acumen’s sabirnetug (ACU193) is the first humanized monoclonal antibody to demonstrate selective target engagement of AβOs, a soluble and highly toxic form of Aβ that accumulates early in AD and triggers synaptic dysfunction and neurodegeneration. Positive topline results from 62 participants in the Phase 1 INTERCEPT-AD trial (NCT04931459) showed sabirnetug to be well-tolerated with a favorable overall safety profile. Study findings including statistically significant, dose-related amyloid plaque reduction comparable to approved and in-review amyloid-directed therapies at similar time points, low overall levels of ARIA-E, and pharmacokinetic data that confirmed proof-of-mechanism, support sabirnetug’s potential to offer differentiated safety and efficacy as a next-generation treatment for early AD.
“We’re proud to have generated one of the most robust Phase 1 datasets in the AD space to-date from INTERCEPT-AD and look forward to presenting key findings from some of our extensive exploratory analyses at this year’s AD/PD meeting,” said Daniel O’Connell, Chief Executive Officer of Acumen. “Fluid biomarkers are of particular interest in the AD field and will continue to advance our understanding of the therapeutic potential of differentiated mechanisms that target soluble, non-plaque forms of Aβ. Our initial findings from the Phase 1 study are promising and sabirnetug’s effect on biomarkers will be further explored in our Phase 2 trial to be initiated in the first half of this year.”
ACU193 lowers cerebrospinal fluid (CSF) neurogranin and pTau181 levels in INTERCEPT-AD Phase 1 study in early AD
In an oral presentation, Acumen will share results from an assessment of CSF biomarkers associated with AD pathology before and after drug exposure in the INTERCEPT-AD study. Effects of sabirnetug on both neurogranin and pTau181 levels in CSF in this Phase 1 study are consistent with downstream pharmacologic effects of the drug. Presentation details as follows:
- Presenter: Erika Cline, PhD, Manager, Bioanalytical Methods, Acumen Pharmaceuticals
- Session: Therapeutic Interventions in AD and PD
- Date & time: Friday, March 8, 3:20 p.m. - 3:35 p.m. WET (Lisbon, UTC+0)
- Location: Auditorium V
Target engagement in INTERCEPT-AD: Development of a novel assay measuring ACU193-amyloid beta oligomer complexes in human CSF
Acumen will also present a poster detailing its method for developing the first assay to directly measure target engagement of AβOs by an immunotherapy (as measured by sabirnetug (ACU193)-AβO complex in CSF) in the INTERCEPT-AD trial. Presentation details as follows:
- Presenter: Erika Cline, PhD, Manager, Bioanalytical Methods, Acumen Pharmaceuticals
- Poster number: P0304 / #1684
- Poster topic: Theme A: β-Amyloid Diseases / A03.b. Drug Development, Clinical Trials: Amyloid Clearance
- Date & time: Wednesday, March 6 and Thursday, March 7, on-demand
Sabirnetug is the nonproprietary name for ACU193 accepted by USAN and INN.
About Sabirnetug (ACU193)
Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble AβOs, which are a highly toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, sabirnetug aims to directly address a growing body of evidence indicating that soluble AβOs are a primary underlying cause of the neurodegenerative process in Alzheimer’s disease. Sabirnetug has been granted Fast Track designation for the treatment of early Alzheimer’s disease by the U.S. Food and Drug Administration.
About INTERCEPT-AD
INTERCEPT-AD was a Phase 1, U.S.-based, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and tolerability, and establishing clinical proof of mechanism, of sabirnetug in patients with early Alzheimer’s disease (AD). Sixty-five individuals with early AD (mild cognitive impairment or mild dementia due to AD) enrolled in this first-in-human study of sabirnetug. The INTERCEPT-AD study consisted of single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts and was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and target engagement of intravenous doses of sabirnetug. More information can be found on www.clinicaltrials.gov, NCT identifier NCT04931459.
About Acumen Pharmaceuticals, Inc.
Acumen, headquartered in Charlottesville, VA, with additional offices in Indianapolis, IN and Newton, MA, 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 early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs, following positive results in INTERCEPT-AD, a Phase 1 clinical trial involving early Alzheimer’s disease patients. For more information, visit www.acumenpharm.com.
Forward-Looking Statements
This press release 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 should be considered an at-risk statement. Words such as “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning the therapeutic potential of Acumen’s product candidate, sabirnetug (ACU193), Acumen’s preparations with respect to its plans to initiate a Phase 2 study, and Acumen’s potential to receive regulatory approval for and bring sabirnetug to patients living with AD. These statements are based upon the current beliefs and expectations of Acumen’s management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of geopolitical events and macroeconomic conditions, such as rising inflation and interest rates, supply disruptions and uncertainty of credit and financial markets. These and other risks concerning Acumen’s programs are described in additional detail in Acumen’s filings with the Securities and Exchange Commission (“SEC”), including in Acumen’s most recent Annual Report on Form 10-K, and in subsequent filings with the SEC. Copies of these and other documents are available from Acumen. Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether, as a result of new information, future events or otherwise.
Investors:
Alex Braun
abraun@acumenpharm.com
Media:
Jessica Laub
ICR Westwicke
AcumenPR@westwicke.com
FAQ
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