sabirnetug SC (ACU193 SC) / Acumen Pharma, Halozyme - LARVOL DELTA

Acumen targets ALTITUDE-AD Phase 2 topline results in late 2026 while advancing subcutaneous Sabirnetug development (MSN News) - "CEO Dan O'Connell reported that Acumen completed enrollment of its 542-participant Phase 2 ALTITUDE-AD study evaluating Sabirnetug for early Alzheimer’s disease....O'Connell also emphasized a late 2026 target for topline ALTITUDE-AD results and highlighted innovations in biomarker screening and assay development, such as the use of plasma phospho-tau 217."

Enrollment closed • P2 data • Alzheimer's Disease

Acumen Pharmaceuticals Announces Topline Results from Phase 1 Study of Subcutaneous Formulation of Sabirnetug in Healthy Volunteers (GlobeNewswire) - P1 | N=28 | NCT06511570 | Sponsor: Acumen Pharmaceuticals | "Acumen Pharmaceuticals, Inc...today announced topline results from its Phase 1 study comparing pharmacokinetics (PK) between subcutaneous (SC) and intravenous (IV) formulations of sabirnetug in healthy volunteers. Weekly SC administration of sabirnetug was well-tolerated with systemic exposure supporting further clinical development....The most frequently reported adverse events included injection site reactions (62.5%), all of which were mild (Grade 1) in severity and resolved. No other safety signals were identified."

P1 data • Alzheimer's Disease

ACU193-102: A Study Comparing the Safety, Tolerability, and Pharmacokinetics of Sabirnetug IV and Sabirnetug + rHuPH20 SC in Healthy Participants (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Acumen Pharmaceuticals | Recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders

Acumen Pharmaceuticals Reports Second Quarter 2024 Financial Results and Business Highlights (GlobeNewswire) - "In July 2024, the Company announced the first subject had been dosed with a subcutaneous formulation of sabirnetug in a Phase 1 pharmacokinetic (PK) comparison study...Topline results are anticipated in the first quarter of 2025...The Company plans to host a virtual R&D Day on Oct. 2, 2024, providing a deep dive into the scientific rationale, Phase 1 clinical results and Phase 2 clinical plans for sabirnetug."

New P2 trial • P1 data • Alzheimer's Disease • CNS Disorders

Acumen Pharmaceuticals Announces First Subject Dosed in Phase 1 Study of Subcutaneous Sabirnetug (ACU193) for Early Alzheimer’s Disease (GlobeNewswire) - "Acumen Pharmaceuticals, Inc...today announced that the first subject has been dosed with a subcutaneous formulation of sabirnetug (ACU193) in a Phase 1 pharmacokinetic (PK) comparison study. The study plans to compare the PK between subcutaneous and intravenous administrations of sabirnetug in healthy volunteers."

Trial status • Alzheimer's Disease • CNS Disorders

A Study Comparing the Safety, Tolerability, and Pharmacokinetics of Sabirnetug IV and Sabirnetug + rHuPH20 SC in Healthy Participants (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Acumen Pharmaceuticals

New P1 trial • Alzheimer's Disease • CNS Disorders

Acumen Pharmaceuticals Announces First Patient Dosed in ALTITUDE-AD, a Phase 2 Clinical Trial of Sabirnetug (ACU193) in Early Alzheimer’s Disease (GlobeNewswire) - "Acumen Pharmaceuticals...announced that the first patient has been dosed with sabirnetug (ACU193) in the ALTITUDE-AD Phase 2 clinical trial designed to evaluate the clinical efficacy and safety of sabirnetug in patients with early AD....ALTITUDE-AD (NCT06335173) is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial currently enrolling at sites in the United States and Canada, with plans for additional study centers in Europe and the UK. The study will enroll approximately 540 people with early AD who will be randomized to receive one of two dose levels of sabirnetug (35mg/kg or 50mg/kg once every four weeks) or placebo....Additionally, Acumen expects to initiate a Phase 1 bioavailability study to support a subcutaneous dosing option of sabirnetug in mid-2024..."

New P1 trial • Trial status • Alzheimer's Disease