AB Science announces that a new independent publication confirms the role of masitinib as a potential therapy in neurodegenerative disorders including Alzheimer's Disease - Seite 2

This research supports results from the phase 2B/3 study, AB09004, that evaluated oral masitinib in patients with mild and moderate Alzheimer’s disease.

Philip Scheltens, Professor of Neurology at the Alzheimer Center Amsterdam, said: “This research provides further supportive evidence that masitinib, through its dual targeting of mast cells and microglia, has a unique and effective profile for neurodegenerative diseases such as Alzheimer's disease and amyotrophic lateral sclerosis.”

As a reminder [3], AB Science recently announced topline results from its Phase 2B/3 study (AB09004) evaluating oral masitinib in patients with mild and moderate Alzheimer’s disease met its predefined primary endpoint. Study AB09004 was an international, randomized, placebo-controlled, phase 2B/3 study evaluating different doses of masitinib as a treatment of patients with confirmed mild to moderate Alzheimer’s disease. This study compared the efficacy and safety of masitinib relative to placebo after 24 weeks of treatment when administered as an add-on therapy to cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine. Two doses of masitinib were tested, masitinib 4.5 mg/kg/day and a titrated dose of masitinib from 4.5 to 6.0 mg/kg/day, with each dose having an independent control arm.

The study demonstrated that masitinib 4.5 mg/kg/day (n=182) generated a significant treatment effect compared with the control arm (n=176) on the primary endpoint of change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), an instrument that measures the effect on cognition and memory (p=0.0003). The study also demonstrated that masitinib 4.5 mg/kg/day generated a significant change from baseline in Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) score, an instrument that assesses self-care and activities of daily living (p= 0.0381). There were significantly fewer patients reaching severe dementia stage (MMSE<10) with masitinib 4.5 mg/kg/day compared with placebo after 24 weeks of treatment (p-value= 0.0446).

[1] Harcha PA, Garcés P, Arredondo C, Fernández G, Sáez JC, van Zundert B. Mast Cell and Astrocyte Hemichannels and Their Role in Alzheimer’s Disease, ALS, and Harmful Stress Conditions. International Journal of Molecular Sciences. 2021; 22(4):1924. https://doi.org/10.3390/ijms22041924

[2] Harcha PA, Vargas A, Yi C, Koulakoff AA, Giaume C, Sáez JC. Hemichannels Are Required for Amyloid β-Peptide-Induced Degranulation and Are Activated in Brain Mast Cells of APPswe/PS1dE9 Mice. J Neurosci. 2015;35(25):9526-9538. Doi:10.1523/JNEUROSCI.3686-14.2015