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Masitinib Alzheimer’s Phase-2B/3 trails reached the primary endpoint
Masitinib Alzheimer’s Phase-2B/3 trails reached the primary endpoint. AB Science announced that its Alzheimer’s disease research drug masitinib clinical phase 2B/3 trial reached the primary endpoint.
On December 16, 2020, French innovative drug development company AB Science announced that its Alzheimer’s research drug masitinib clinical phase 2B/3 trial reached the primary study endpoint, the trial name is AB09004.
AB09004 is an international multi-center, randomized, placebo-controlled Phase 2B/3 clinical study with a treatment cycle of 24 weeks, evaluating different doses of masitinib in the treatment of patients with mild to moderate Alzheimer’s disease. To compare the efficacy and safety of masitinib and placebo under simultaneous administration of cholinesterase inhibitors (donepezil, rivastigmine, or galantamine) and/or memantine. There are two dosages of masitinib in the experiment, 4.5 mg/kg/day and 4.5-6.0 mg/kg/day, and each dosage is independently tested in a single arm.
Studies have shown that, compared with the control group (n=176), the Alzheimer’s Cognitive Scale (ADAS-Cog) and the Alzheimer’s Activity of Daily Living Scale (ADCS-ADL) assessed 4.5 mg/ The kg/day dose of masitinib (n=182) had a significant therapeutic effect, with p values of 0.0003 and 0.0381, respectively.
After 24 weeks of treatment, compared with the placebo group, the number of patients who progressed to severe dementia (MMSE<10) was significantly reduced (p value = 0.0446).
The safety of masitinib at a dose of 4.5 mg/kg/day is acceptable, and the previous tolerability curve of masitinib is consistent:
a) In the masitinib group, 79.5% of patients had at least one adverse event, compared with 74.6% in the control group
b) 5.9% of patients had at least one serious adverse event (non-fatal) in the masitinib group, compared with 2.9% in the control group
c) 18.9% of patients had at least one serious adverse event in the masitinib group, compared to 16.8% in the control group
AB Science will hold an online video conference at 11:00-12:00 AM Eastern Time on December 17, 2020 (Thursday) to discuss and share data on the research.
According to the results of AB09004, AB Science applied for a new patent. If approved, AB Science will retain the patent rights for masitinib for Alzheimer’s disease until 2041.
Masitinib is a new oral tyrosine kinase inhibitor that targets important immune cells: mast cells and macrophages. Based on its unique mechanism of action, masitinib can be effective in tumors, inflammatory diseases and certain central nervous system diseases.
About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKI) and has been listed on the Paris Stock Exchange.
(source:internet, reference only)