Cassava Sciences (NASDAQ:SAVA) reported additional data from its Phase 2b study of sumifilam for the treatment of Alzheimer’s disease (AD).
The study enrolled 64 patients with mild-to-moderate AD, 50-to-85 years of age, who received either 50 mg or 100 mg of sumifilam, or placebo, twice-daily, for 28 days.
The most recent data demonstrate that AD patients treated with sumifilam showed a statistically significant treatment benefit on HMGB1, a protein that causes neuroinflammation and neuron loss; as well as a treatment benefit on blood-brain barrier integrity.
“The ability to improve multiple biomarkers of disease with one drug is a unique achievement,” Remi Barbier, Cassava’s president and CEO, said in a statement.
“We believe these exciting clinical results create a time of rapid strategic momentum for the company, to include development plans to evaluate sumifilam in a Phase 3 clinical program in patients with AD,” he added.
In May 2020, the company reported that the study failed to meet its primary endpoint of a statistically significant effect of sumifilam, compared with placebo, on cerebrospinal fluid levels of tau protein. Final trial results, reported in September 2020, demonstrated that AD patients treated with sumifilam showed statistically significant improvements in eight biomarkers of disease, compared with those who took placebo.