Dosing Begins in ACU193 Trial, Targeting Toxic Amyloid Beta

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by Patricia Inacio PhD |

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The first patient has been dosed in a Phase 1 trial testing ACU193, an antibody designed by Acumen Pharmaceuticals to target toxic forms of amyloid beta — called amyloid-beta oligomers — as a potential therapy for early Alzheimer’s disease.

The INTERCEPT-AD Phase 1 trial (NCT04931459) is expecting to enroll approximately 62 patients, ages 55-85, with mild cognitive impairment or mild dementia due to Alzheimer’s disease, across six clinical sites in Arizona, Florida, Georgia, and Ohio.

Recruitment is now open across all three Florida sites and in Georgia. More information is available here.

“We are very pleased to report this first clinical development milestone for ACU193,” Daniel O’Connell, president and CEO of Acumen, said in a press release.

Participants will be randomly assigned to receive single and multiple escalating doses of ACU193, delivered into the vein (intravenously), or a placebo.

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The trial’s primary goals are to evaluate ACU193’s safety, tolerability, and pharmacokinetics, or the medicine’s movement into, through, and out of the body. ACU193’s capacity to target amyloid-beta oligomer also is a key endpoint or goal, according to the company.

“We are all very excited about evaluating ACU193 in the INTERCEPT-AD trial,” said Eric Siemers, MD, chief medical officer for Acumen.

“Our goal for this Phase 1 clinical trial is to establish proof of mechanism for ACU193, including overall safety and tolerability, pharmacokinetics and target engagement,” Siemers said. “We have also incorporated standard clinical outcomes for AD as well as exploratory assessments.”

Alzheimer’s disease is caused by deposits of toxic clumps of amyloid beta protein in the brain. Amyloid beta exists in different forms, though the toxic form that promotes nerve cell death and neurodegeneration is its oligomer form — when several single units (monomers) of the protein aggregate or clump together.

According to Acumen, by selectively targeting the most toxic form of amyloid beta, ACU193 is believed to have an advantage compared with other antibodies in addressing the underlying cause driving the disease.

“Based on ACU193’s unique mechanism of action, we believe it has the potential for improved efficacy and for improved safety compared to other monoclonal antibodies in development,” Siemers said.

The study is expected to run through December 2022.

“We are encouraged by recent momentum and the breadth of scientific innovation that is being applied to Alzheimer’s research. We believe ACU193 has distinct potential to address the continued unmet medical needs of people living with Alzheimer’s disease,” added O’Connell.