AM805 / Amlogenyx - LARVOL DELTA

Amlogenyx Presents Preclinical Data on AM805, a Potentially Transformative Investigational Gene Therapy for Alzheimer’s Disease (GlobeNewswire) - "The findings will be discussed in an oral presentation at the 2026 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting....In 5xFAD and Tg2576 mouse models, AM805 significantly reduced both intraneuronal Aβ42 accumulation, including amyloid localized to neuronal cell bodies and axons, as well as the size and number of amyloid plaques outside the cells....Intrathecal administration of AM805 was well tolerated at therapeutically relevant doses, with no significant adverse findings....The Company plans to pursue an Investigational New Drug (IND) application submission to the U.S. Food and Drug Administration for AM805 later this year and initiate a Phase 1/2 study in 2027."

IND • New P1/2 trial • Preclinical • Alzheimer's Disease

Amlogenyx Announces Positive Preclinical Data on AM805, a Potent Amyloid-Degrading Protease for the Treatment of Alzheimer’s Disease (GlobeNewswire) - "The data will be presented in a poster session, taking place March 19-21, and in an ePoster at the AD/PD 2026 International Conference....Study results showed that all routes of dosing resulted in increased PPCA activity and reduced amyloid-positive brain area in a dose-dependent manner in mouse models of both severe and moderate Alzheimer’s disease. The magnitude of reduction achieved was comparable to, and in some cases exceeded, that reported for approved Alzheimer’s disease monoclonal antibodies....The Company plans to pursue an Investigational New Drug (IND) application submission to the U.S. Food and Drug Administration for AM805 in 2027."

IND • Preclinical • Alzheimer's Disease