Cassava Sciences Announces Additional Clinical Data from a Phase 2b Study of Sumifilam in Alzheimer’s Disease

Alzheimer’s Patients Treated with Sumifilam Showed a Statistically Significant (p<0.001) Treatment Benefit on HMGB1, 
a Protein that Triggers Neuroinflammation and Loss of Neurons

Alzheimer’s Patients Treated with Sumifilam Also Showed
a Treatment Benefit (p<0.05) on Blood-brain Barrier Integrity

Clinical Dataset to be Presented November 7^th at CTAD 2020 Conference

AUSTIN, Texas, Nov. 04, 2020 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) today announced additional clinical data of a Phase 2b study with sumifilam, its lead drug candidate, in patients with Alzheimer’s disease. In a clinical study funded by the National Institutes of Health (NIH), sumifilam decreased levels of a protein called HMGB1 and improved measurements of the integrity of the blood-brain barrier (BBB). The ability of a drug candidate to decrease HMGB1 and improve BBB integrity in patients with Alzheimer’s disease has not been previously reported in the science literature. Sumifilam is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A protein in the brain.

“The ability to improve multiple biomarkers of disease with one drug is a unique achievement,” said Remi Barbier, President & CEO of Cassava Sciences. “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 Alzheimer’s disease.”

Additional Phase 2b Study Results
Additional clinical data include changes in levels of HMGB1 protein and measurements of the integrity of the blood-brain barrier from baseline to Day 28 (all p-values versus placebo):

Sumifilam Significantly Reduced Levels of HMGB1 in Cerebrospinal Fluid (CSF):

• HMGB1 decreased 33% (p<0.001) in patients treated with 50 mg sumifilam
• HMGB1 decreased 32% (p<0.001) in patients treated with 100 mg sumifilam

Sumifilam Significantly Improved the Integrity of the Blood-brain Barrier (BBB):

• CSF IgG decreased 30% (p<0.05) in patients treated with 50 mg sumifilam
• CSF IgG decreased 30% (p<0.05) in patients treated with 100 mg sumifilam
• CSF albumin decreased 15% (p<0.05) in patients treated with 50 mg sumifilam
• CSF albumin decreased 28% (p<0.05) in patients treated with 100 mg sumifilam

Sumifilam Improved the Albumin Ratio, a Test of Blood-brain Barrier (BBB) Permeability: