On 14 September, the biopharmaceutical company Cassava Sciences announced final results of its Phase IIb study of sumifilam (formerly PTI-125) in Alzheimer’s disease (AD). The Phase IIb trial was a randomised, placebo-controlled, double-blind and multi-center clinical study of sumifilam in mild to moderate AD. A total of 64 US research participants received placebo or sumifilam (50 or 100mg) twice daily for 28 days.
Sumifilam was found to be safe and well-tolerated. Findings reported that participants treated with sumifilam showed statistically significant improvements in multiple biomarkers of AD pathology compared to those who received the placebo. In addition, research participants treated with sumifilam showed improvements in cognition compared to the placebo group. The company is conducting a long-term, open-label, and multi-center extension study of sumifilam (100 mg) twice daily for 12 months. The company reported that this open-label study is currently over 50% enrolled.