French biotech firm AB Science (Euronext - FR0010557264 - AB) yesterday announced that the Phase IIb/III study (AB09004 - NCT01872598) evaluating oral masitinib in patients with mild and moderate Alzheimer’s disease met its predefined primary endpoint, with the news seeing the firm’s shares rise as high as 17.48 euros, and closing the day up nearly 39% at 14.34 euros.
The study demonstrated that masitinib 4.5mg/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 4.5mg/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 4.5mg/kg/day compared with placebo after 24 weeks of treatment (p-value= 0.0446). The safety of masitinib 4.5mg/kg/day was acceptable and consistent with the known tolerability profile for masitinib.
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