Acumen Pharmaceuticals has presented positive topline results from an early-stage study of its investigational Alzheimer’s disease therapy at this year’s Alzheimer’s Association International Conference (AAIC).

The drug, ACU193, works by targeting and binding to amyloid beta oligomers, a toxic and soluble version of the amyloid protein that forms brain plaques associated with Alzheimer’s disease.

Results from the phase 1 randomised, placebo-controlled INTERCEPT-AD study of 62 patients with early Alzheimer's disease showed the candidate was generally well tolerated throughout both single-ascending and multiple-ascending dose cohorts.

Patients who received higher doses of the drug also showed a reduction in amyloid plaque after six to 12 weeks, the company said, adding that the study suggests the drug can be given as a monthly intravenous infusion.

Commenting on the positive results, Acumen’s president and chief executive officer, Daniel O’Connell, said: "ACU193’s observed dose-related central target engagement, rapid reduction of amyloid plaque and compelling safety profile validate our confidence in ACU193’s differentiated mechanism of action: selectively targeting amyloid beta oligomers.

“We believe that the robust data package generated by this comprehensive phase 1 study establishes ACU193’s broad therapeutic index and guides a future clinical dosing rationale.”

The company said it will be discussing the results with regulators later this year to inform the next phase of development for ACU193 and determine a timeline for progressing to a phase 2/3 clinical study.

The US Food and Drug Administration has already granted the candidate fast track designation for early-stage Alzheimer’s disease. ACU193 will now benefit from the regulator’s fast track process, which is designed to improve the efficiency of product development and accelerate the review of treatments for serious conditions.

Chief medical officer of Acumen, Eric Siemers, said he was proud that the team had “made significant progress developing the first target engagement assay for an amyloid beta oligomer-targeted antibody”.

“Taken together with the compelling safety profile at doses that engage the target, and pharmacokinetic data that supports monthly dosing, ACU193 has the distinct potential to be a differentiated antibody for the treatment of early Alzheimer’s disease,” Siemers said.

Source: pmlive.com