AB Science Issues A Corrective Press Release Regarding Adverse Events Information from Study AB09004 Reported on December 16, 2020
December 17, 2020 at 01:53 am EST
AB Science S.A. announced that the press release issued on December 16, 2020 regarding the results from study AB09004, which evaluated masitinib in the treatment of Alzheimer disease, contained a material error in the adverse events information reported. The percentage of adverse events observed in study AB09004 study comparing 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, were the following with masitinib 4.5 mg/kg/day: 87.0 % of patients had at least one adverse event in the masitinib arm versus 77.5 % in the control arm, 13.0 % of patients had at least one serious adverse event (non-fatal) in the masitinib arm versus 5.4 % in the control arm, 26.5 % of patients had at least one severe adverse event in the masitinib arm versus 19.3 % in the control arm
The results of the efficacy analysis remain unchanged.