Cassava Sciences Inc. (NASDAQ:SAVA) has announced additional clinical data of its phase 2b study with its lead drug candidate, sumifilam, in Alzheimer’s disease patients.
The study was funded by NIH
In the National Institutes of Health (NIH) funded clinical study, sumifilam demonstrated reduced levels of HMGB1 protein. Also, it showed enhanced measurements of the integrity of the blood-brain barrier (BBB). This is a significant step since a treatment to reduce HMGB1 and enhance BBB integrity in Alzheimer’s disease patients has not been reported before in studies. Sumifilam is Cassava Science’s proprietary, oral, small molecule drug with the potential of restoring normal function and shape of altered filamin A protein in the brain.
Remi Barbie, the CEO and President of Cassava Sciences, said that the ability to enhance multiple biomarkers of disease with just one drug is a huge achievement. He said that these exciting results create a time of quick strategic momentum for Cassava Science to include development plans in evaluating sumifilam in a third phase clinical study in Alzheimer’s disease patients.
Sumifilam reduced HMGB1 protein levels
The additional Phase 2b clinical study data includes changes in HMGB1 protein levels as well as BBB integrity measurement from baseline to day 28 against placebo. Sumifilam reduced HMGB1 by 33% in patients who received 50 mg sumifilam and 32% for those treated with 100mg sumifilam. Also, the integrity of BBB improved with CSF IgG reducing by 30% in both patients that received 50 mg and 100mg sumifilam. On the other hand, CSF albumin decreased 15% and 28% for patients that received 50mg and 100mg sumifialm, respectively.
Usually, BBB permeability is evaluated clinically through comparison of albumin levels in Plasma and CSF. The albumin ratio is a BBB permeability test since albumin protein cannot be synthesized in CSF. Therefore albumin in CSF is from Plasma via the BBB. The albumin ratio is regularly elevated in dementia patients, as well as those with other disorders. In the study albumin ratio remained unchanged for Alzheimer’s disease patients on placebo.