News

New partners team up for Phase 2 trial of novel lithium therapy AL001

Alzamend Neuro is partnering with Massachusetts General Hospital to conduct a Phase 2 clinical trial of AL001, an oral therapy being developed for dementia related to Alzheimer’s disease. The trial will compare the brain levels of AL001, a novel lithium-delivery system, with those of marketed lithium, in healthy…

Oral AMX0035 found to improve core Alzheimer’s-related biomarkers

Amylyx Pharmaceuticals‘ investigational oral therapy AMX0035 reduces the levels of several biomarkers associated with Alzheimer’s disease, according to an analysis of data from the PEGASUS trial. “The results from this exploratory analysis suggest that AMX0035 engages important pathways implicated in the [development] of Alzheimer’s disease and other neurodegenerative…

Lomecel-B granted FDA RMAT status for mild Alzheimer’s

The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Longeveron’s experimental cell therapy Lomecel-B for mild Alzheimer’s disease. The designation is designed to accelerate the development and review processes for regenerative medicine candidates, including cell therapies, intended to treat, modify, reverse,…

FDA approves donanemab, now Kisunla, to treat early Alzheimer’s

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly‘s antibody therapy donanemab, now Kisunla, for certain adults with Alzheimer’s disease. Specifically, Kisunla is indicated for patients with early symptomatic Alzheimer’s — to include individuals with mild cognitive impairment or mild dementia, and confirmed evidence of…