Acumen Pharmaceuticals & Halozyme Enter Global Collaboration & License Agreement to Develop Subcutaneous Formulation of ACU193 With ENHANZE Technology

Acumen Pharmaceuticals, Inc. recently announced a global non-exclusive collaboration and license agreement with Halozyme Therapeutics Inc. to provide Acumen access to Halozyme’s ENHANZE drug delivery technology, based on a recombinant human hyaluronidase PH20 enzyme (rHuPH20), for the development of a subcutaneous formulation of ACU193, the first clinical-stage AβO-targeting antibody. ENHANZE has been commercially validated in seven approved therapies, with global collaborations covering more than 60 therapeutic targets.

Acumen intends to explore using ENHANZE with ACU193 and plans to initiate Phase 1 development in human subjects in mid-2024 to compare the pharmacokinetics (PK) of a subcutaneous form of ACU193 to the intravenous (IV) form. Acumen recently completed the Phase 1 INTERCEPT-AD trial in patients with early AD, which demonstrated robust, dose dependent target engagement for ACU193 and additionally produced amyloid plaque reduction following three administrations of ACU193 at 25 mg/kg or 60 mg/kg. At or near a three-month timepoint, ACU193 reduced amyloid plaque to a comparable level as that observed with administration of LEQEMBI.

Under the terms of the agreement, in return for an upfront payment to Halozyme and other considerations, Acumen will receive non-exclusive rights to ENHANZE. Acumen is obligated to make future payments to Halozyme, subject to achievement of specified development, regulatory, and sales-based milestones. Halozyme will also be entitled to receive royalties on sales of commercialized medicines using the ENHANZE technology.

“We are thrilled to partner with Halozyme, the market leader in rapid subcutaneous drug delivery technology, and look forward to working closely with their team to advance a subcutaneous formulation of ACU193,” said Daniel O’Connell, President and Chief Executive Officer. “Acumen is a patient-driven organization, and with the recent momentum of subcutaneous administration of Alzheimer’s therapies, we look forward to being able to provide another treatment option that has the potential to broaden patient access and decrease treatment burden.”

Acumen, headquartered in Charlottesville, VA, with additional offices in Indianapolis, IN, and Newton, MA, is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, ACU193, a humanized monoclonal antibody that selectively targets toxic soluble AβOs, following positive topline results in INTERCEPT-AD, a Phase 1 clinical trial involving early Alzheimer’s disease patients. For more information, visit www.acumenpharm.com.