Acumen’s ACU193 Antibody for Early Alzheimer’s on FDA Fast Track

Acumen Pharmaceuticals’ investigational antibody ACU193 has been granted fast track status by the U.S. Food and Drug Administration (FDA), which may help speed up its development for the treatment of early Alzheimer’s disease.

With this designation, the company is eligible for certain benefits to get a potential new treatment out to patients sooner.

These include more frequent meetings with the agency, during which Acumen can get proper guidance and direction on which study designs are best to generate the data needed to support a submission for approval of ACU193.

“We look forward to collaborating with the FDA to advance the development of ACU193,” Daniel O’Connell, Acumen’s president and CEO, said in a press release.

“Treating Alzheimer’s disease ultimately requires therapies that target different components of the disease pathway, and we are developing ACU193 with the goal of providing patients with more treatment options,” O’Connell added.

Ongoing INTERCEPT-AD trial still recruiting at multiple sites in US

An ongoing Phase 1 clinical study (NCT04931459), called INTERCEPT-AD, is currently testing how safe and well-tolerated ACU193 is versus a placebo in up to 62 people, age 55–90, with mild cognitive impairment or mild dementia due to Alzheimer’s.

The trial is also testing the antibody’s pharmacokinetics (its movement into, through, and out of the body) and pharmacodynamics (its effects in the body) after it is administered into the vein (intravenously).

INTERCEPT-AD had its first patient dosed about one year ago and is still recruiting at multiple sites across the U.S.

Those who enter the study are randomly given a placebo or ACU193, delivered either as a single dose or multiple ascending doses. Patients in the multiple ascending dose group receive up to three doses of the treatment.

Treating Alzheimer’s disease ultimately requires therapies that target different components of the disease pathway, and we are developing ACU193 with the goal of providing patients with more treatment options

Insoluble clumps of the beta-amyloid protein, known as plaques, accumulate in the brain of people with Alzheimer’s and have been long-standing culprits behind the cause of the disease. However, beta-amyloid also exists as soluble oligomers, in which a few units of the protein are bonded together.

These very toxic forms of beta-amyloid can stick at the junction between two nerve cells, called a synapse, where they prevent the nerve cells from communicating with one another. This is thought to help set off nerve cell degeneration and death.

By binding to soluble oligomers of amyloid-beta at the synapses, ACU193 is expected to help keep nerve cells functioning. This could help slow the cognitive decline that is observed in people with Alzheimer’s, with the potential to ease their symptoms.

ACU193 is highly selective for the soluble oligomers relative to other experimental treatments that target the amyloid-beta protein, according to Acumen. Because it does not target amyloid-beta plaques, the risk of causing amyloid-related imaging abnormalities, which are suggestive of brain swelling or bleeding, is expected to be low.

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