(AOF) – AB Science has received from the French Medicines Agency (ANSM) as well as from AEMPS (Spanish agency) and EOF (Greek agency), the first regulatory authorizations to initiate its confirmatory study phase 3 (AB21004) evaluating masitinib in patients with mild to moderate Alzheimer’s disease. It will assess the safety and efficacy of masitinib in patients with mild or moderate Alzheimer’s disease, in combination with reference treatments, namely cholinesterase inhibitors and/or memantine.
The objective of the study is to confirm the effect of treatment with masitinib at a dose of 4.5 mg/kg/day in addition to a cholinesterase inhibitor and/or memantine in patients with mild to moderate Alzheimer’s disease. The main endpoint of the study will be to assess the effect of masitinib on the change in the ADCS-ADL score and the ADAS-Cog-11 score, compared to inclusion.
Professor Bruno Dubois, MD, Principal Investigator of the study and Professor of Neurology at Sorbonne University, France, commented: “There are no treatment options for patients with Alzheimer’s disease. “Mild to Moderate Alzheimer’s. The results of the first Phase 2B/3 study, AB09004, were very encouraging, especially considering that this patient population is difficult to treat.”
Before adding: “First, we found the optimal dose among the three tested. Second, masitinib administered at a dose of 4.5 mg/kg/day significantly slowed cognitive deterioration compared to placebo and also shown a reduction in loss of functional ability in activities of daily living Equally important, the tolerability of masitinib when given in addition to a cholinesterase inhibitor and/or memantine was consistent with its known risk profile and was not worsened in this elderly population.”
LEXICON
Clinical trials (Phases I, II, III)
Phase I: small-scale testing of the molecule on humans to assess its safety, tolerance, metabolic and pharmacological properties. Phase II: evaluation of tolerance and efficacy on several hundred patients to identify side effects. Phase III: assessment of the overall benefit/risk ratio with several thousand patients.
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