Roche's Trontinemab Shows Promising Results in Alzheimer’s Therapy Trials

Roche Holding AG, a leading player in the pharmaceutical industry, has announced promising findings from its ongoing Alzheimer's therapy trials, highlighting the efficacy of its investigational drug, trontinemab. The results, presented at the Alzheimer’s Association International Conference (AAIC) held from July 27-30, 2025, in Toronto, Canada, indicate that the drug demonstrates significant benefits in reducing amyloid levels in patients with early Alzheimer's disease.

According to data from the Phase Ib/IIa Brainshuttle AD study (NCT04639050), 91% of patients receiving the high-dose cohort of trontinemab achieved amyloid reduction below the 24 centiloid positivity threshold after 28 weeks. Furthermore, 72% of participants recorded deep clearance below 11 centiloids, suggesting a robust response to the treatment. Notably, the trial also observed early reductions in various fluid biomarkers associated with Alzheimer’s, including total tau, phosphorylated Tau (pTau)181, pTau217, and neurogranin, measured in cerebrospinal fluid (CSF) and plasma.

Dr. Levi Garraway, Chief Medical Officer of Roche, emphasized the importance of trontinemab, stating, "This therapy is designed to target a key driver of Alzheimer’s disease biology more effectively in the brain. Combining new treatment avenues with advanced diagnostics may enable earlier and potentially more effective intervention." The safety profile of trontinemab was also found to be favorable, with amyloid-related imaging abnormalities (ARIA-E) reported in less than 5% of patients, all cases being mild and transient.

In preparation for two forthcoming Phase III studies, dubbed TRONTIER 1 and 2, Roche is set to investigate the efficacy and safety of trontinemab in individuals diagnosed with early Alzheimer’s disease. The primary endpoint for these studies will assess changes in cognition and function as measured by the Clinical Dementia Rating – Sum of Boxes scale after an 18-month treatment period. Secondary endpoints will encompass a broader range of cognitive and functional assessments, including behavioral symptoms and quality of life metrics.

The Alzheimer's market is poised for substantial growth, with GlobalData projecting an increase to $19.3 billion in the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and China) by 2033. If approved, trontinemab could potentially reach sales of $712 million by 2031.

Roche's advancements come at a crucial time, as the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recently issued a positive opinion for Eli Lilly’s Alzheimer’s drug Kisunla (donanemab), albeit for a limited patient population. This decision highlights the ongoing challenges faced by new Alzheimer’s therapies in gaining widespread approval, particularly given the previous rejections by the National Institute for Health and Care Excellence (NICE) for other treatments such as Eli Lilly’s Kisunla and Eisai’s Leqembi (lecanemab).

As Roche prepares to initiate further trials and pursue regulatory approval, the implications of these developments are significant. The ability to effectively treat or even delay the progression of Alzheimer’s disease could transform the lives of millions affected by this debilitating condition. With ongoing advancements in research and treatment modalities, the future landscape of Alzheimer’s therapy appears increasingly hopeful, setting the stage for potential breakthroughs in understanding and managing this complex disease.