Acumen Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company listed on NASDAQ under the ticker ABOS, has disclosed its financial results for the first quarter of 2024 along with a business update. The company is engaged in developing a novel therapeutic,
sabirnetug (ACU193), which targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of
Alzheimer’s disease (AD).
In May 2024, Acumen announced the initiation of its ALTITUDE-AD study, a Phase 2 clinical trial to assess the efficacy and safety of sabirnetug in treating early-stage AD. The trial follows promising results from the Phase 1 INTERCEPT-AD study, which demonstrated sabirnetug's selective engagement with synaptotoxic AβOs. The first patient in the Phase 2 study was recently dosed, highlighting a significant milestone for the company. Acumen CEO Daniel O’Connell emphasized the company's commitment to advancing sabirnetug's clinical development efficiently and thoughtfully, aiming to offer a best-in-class therapeutic option for patients.
The ALTITUDE-AD study is a multi-center, randomized, double-blind, placebo-controlled trial, with approximately 540 participants who have
mild cognitive impairment or
mild dementia due to AD. The study is being conducted across various investigative sites in the United States and Canada, with plans to expand to Europe and the UK.
In addition to the Phase 2 trial, Acumen plans to initiate a Phase 1 study in mid-2024 to explore a subcutaneous dosing option for sabirnetug. This initiative aims to extend the product profile and provide alternative administration methods for patients, further underscoring Acumen’s strategic priorities.
Acumen also highlighted a recent collaboration agreement with
Lonza, a global partner in the pharmaceutical and biotech sectors. This partnership covers the manufacturing of sabirnetug for clinical development and potential commercialization. Leveraging Lonza’s regulatory expertise and manufacturing capabilities, Acumen aims to streamline the development process for sabirnetug.
Financially, Acumen reported a cash balance of $296.6 million as of March 31, 2024, which is expected to sustain its clinical and operational activities until the first half of 2027. The company’s research and development (R&D) expenses for the first quarter of 2024 amounted to $12.4 million, up from $8.7 million in the same period in 2023. This increase was primarily due to higher personnel costs, manufacturing and material expenses, and consulting fees. General and administrative (G&A) expenses also rose to $5.3 million from $4.4 million, mainly due to increased personnel costs.
Acumen reported a net loss of $14.9 million for the first quarter of 2024, compared to a net loss of $11.3 million for the same period in 2023. The increase in net loss was attributed to higher R&D and G&A expenses. Despite these losses, the company’s financial position remains strong, supported by substantial cash reserves and strategic financial planning.
Sabirnetug, Acumen’s leading product candidate, is a humanized monoclonal antibody designed to selectively target toxic soluble AβOs, which are believed to play a critical role in the neurodegenerative process of Alzheimer’s disease. The drug has received Fast Track designation from the U.S. Food and Drug Administration for treating early-stage AD and has shown promising results in early clinical trials.
The ALTITUDE-AD study is poised to further evaluate the potential of sabirnetug in slowing cognitive and functional decline in AD patients. The study’s design includes infusions administered once every four weeks, with the goal of providing robust data on the drug’s efficacy and safety.
In summary, Acumen Pharmaceuticals is making significant strides in the clinical development of sabirnetug for Alzheimer’s disease. With ongoing clinical trials, strategic collaborations, and a solid financial foundation, the company is well-positioned to advance its mission of developing innovative treatments for neurodegenerative diseases.
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