On 6 October, the biopharmaceutical company Cassava Sciences announced the initiation of an initial Phase III study evaluating the safety and efficacy of simufilam, its investigational oral treatment for Alzheimer’s disease (AD). A second Phase III study of simufilam in AD is expected to begin by the end of the year. Simufilam is a small molecule drug targeting the altered form of filamin A found in the AD brain to restore its normal shape and function.
The first Phase III trial, called RETHINK–ALZ, is designed to evaluate the safety and efficacy of oral simufilam (100mg) in people with mild to moderate AD. Around 750 participants, aged 50 to 87 years, will be randomly assigned to receive either a placebo or tablets of simufilam, twice daily, for one year. The second Phase III study, called REFOCUS-ALZ, will evaluate the safety and efficacy of oral simufilam (100 mg and 50 mg) over 18 months in approximately 1000 participants, aged 50 to 87 years old with mild to moderate AD. Both studies will recruit participants in the US, Canada and eventually overseas.
