Acumen Pharmaceuticals completes Phase 2 trial enrollment

NEWTON, Mass. - Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a biopharmaceutical company focused on Alzheimer’s disease treatments, announced today the completion of enrollment for its Phase 2 ALTITUDE-AD trial. The study is evaluating the efficacy and safety of sabirnetug (ACU193), a novel therapeutic targeting soluble amyloid beta oligomers (AβOs) in patients with early Alzheimer’s disease. With a market capitalization of $71.49 million, InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 10.43, indicating robust short-term financial stability.

The enrollment, which concluded ahead of schedule, involved 542 participants across the United States, Canada, the European Union, and the United Kingdom. Acumen’s President and CEO, Daniel O’Connell, expressed gratitude towards the patients, investigators, and clinical teams for their contributions to the efficient completion of this phase. The company anticipates reporting topline results, including efficacy and safety data, in late 2026. According to InvestingPro analysis, while the company holds more cash than debt on its balance sheet, it’s currently experiencing rapid cash burn - a critical factor for investors monitoring clinical-stage biotech companies. Get access to 10+ additional ProTips and comprehensive financial metrics with InvestingPro.

Sabirnetug is a humanized monoclonal antibody and the first of its kind to show selective engagement with AβOs in Alzheimer’s patients. AβOs are considered toxic and contribute to synaptic dysfunction and neurodegeneration in the disease’s early stages. The Phase 1 INTERCEPT-AD clinical trial suggested that sabirnetug was well-tolerated and demonstrated a dose-dependent reduction in amyloid plaques.

The ALTITUDE-AD trial is a randomized, double-blind, placebo-controlled study. Participants were assigned to receive either sabirnetug or a placebo once every four weeks. The primary measure of the trial is the change from baseline in the Integrated Alzheimer’s Disease Rating Scale (iADRS) at 18 months. Secondary endpoints include various clinical scales and Alzheimer’s disease biomarkers, with standard safety measures and MRIs also being assessed.

Acumen Pharmaceuticals has been granted Fast Track designation by the U.S. Food and Drug Administration for sabirnetug’s development in early Alzheimer’s disease. This status is aimed at expediting the review of drugs that treat serious conditions and fill an unmet medical need.

The completion of this trial’s enrollment marks a significant milestone for Acumen, as it continues to investigate the potential of sabirnetug as a next-generation treatment for Alzheimer’s disease. The information for this article is based on a press release statement. Despite the stock’s recent decline of over 50% in the past six months, analyst price targets range from $6 to $15, suggesting significant potential upside according to InvestingPro data. Discover detailed valuation analysis and more insights in the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.

In other recent news, Acumen Pharmaceuticals announced positive results from a Phase 1 study of their Alzheimer’s drug, sabirnetug. The study showed that weekly subcutaneous injections were well-tolerated among participants and demonstrated sufficient systemic exposure, justifying further clinical trials. No significant safety concerns were noted, with only mild injection site reactions reported, which resolved without complications. Sabirnetug, a humanized monoclonal antibody, has been granted Fast Track designation by the FDA for treating early Alzheimer’s disease. The drug uses Halozyme’s ENHANZE® technology to enhance absorption when administered subcutaneously. Acumen is currently evaluating sabirnetug in the ongoing Phase 2 ALTITUDE-AD trial, which aims to assess its effectiveness in slowing cognitive and functional decline in early Alzheimer’s patients. The trial, which began in 2024, is a double-blind, placebo-controlled study involving approximately 540 participants across multiple countries. The company continues to advance its clinical pipeline, though it acknowledges the inherent risks and uncertainties in drug development.

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