Acumen Pharma's Stock Doubles In One Session - Here's Why

Acumen Pharmaceuticals Inc ABOS presented topline results from the Phase 1 INTERCEPT-AD trial of ACU193, the first clinical-stage amyloid beta oligomers (AβO) targeting antibody therapy in early AD, at the Alzheimer's Association International Conference (AAIC) 2023.

Topline results demonstrated that ACU193 was generally well-tolerated, meeting the primary objective of the Phase 1 study in both single and multiple doses in 60 participants with early AD. 

Dose levels were 2, 10, 25, and 60 mg/kg for one to three doses administered intravenously. 

Higher doses of ACU193 (60 mg/kg every 4 weeks [Q4W] and 25 mg/kg every 2 weeks [Q2W]) showed a statistically significant reduction in amyloid plaque load.

25% reduction in 60 mg/kg Q4W cohort at day 63 and a 20% reduction in 25 mg/kg Q2W cohort at day 70.

The overall rate of amyloid-related imaging abnormalities – edema (brain swelling) (ARIA-E) was 10.4%, including one symptomatic ARIA-E (2.1%). 

Another 8.3% developed bleeding in the brain associated with treatment, known as ARIA-H.

Pharmacokinetic results in serum and cerebrospinal fluid (CSF) demonstrated statistically significant dose proportionality and support monthly dosing of ACU193. 

Statistically significant, dose-related central target engagement was observed.

Acumen plans to discuss these results with regulators to assess the next steps for the clinical development of ACU193 and determine a timeline for progressing to a Phase 2/3 clinical study.

Price Action: ABOS shares are up 97.40% at $12.39 during the premarket session on the last check Monday.