Acumen Pharmaceuticals, Inc. (ABOS), a clinical-stage biopharmaceutical company, Monday announced positive topline results from the Phase 1 INTERCEPT-AD trial of ACU193, the first clinical-stage amyloid beta oligomer or AßO targeting antibody therapy in early Alzheimer's disease.
The topline results from the trial met primary and secondary objectives, demonstrating proof-of-mechanism for ACU193.
The Phase 1 trial was a first-in-human, randomized, double-blind, placebo-controlled study in both single and multiple doses in 60 participants with early AD.
In the trial, ACU193 was generally well-tolerated with a compelling overall safety profile, meeting the primary objective of this Phase 1.
According to the company, higher doses of ACU193 showed a statistically significant reduction in amyloid plaque load as determined by amyloid PET after 6-12 weeks. This finding provides evidence that ACU193 is active in the brain.
The results were presented at the Alzheimer's Association International Conference 2023, taking place in Amsterdam and online from July 16-20, 2023.
Daniel O'Connell, President and Chief Executive Officer of Acumen, 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."
The company expects to interact with the FDA in the fourth quarter to inform the next phase of development for ACU193.
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