Cassava Sciences Announces Additional Clinical Data from a Phase 2b Study of Sumifilam in Alzheimer’s Disease - Seite 3

Late-breaking Presentation at CTAD 2020
Clinical results of a Phase 2b study of sumifilam were selected as a late-breaking oral presentation by the 13^th international conference on Clinical Trials on Alzheimer’s Disease (CTAD). CTAD is a prestigious annual conference focused on Alzheimer’s clinical research and takes place this year as a virtual event on November 4-7^th, 2020.

On Saturday, November 7^th, Company scientists will present an oral presentation titled, “Sumifilam Significantly Improves Eleven CSF Biomarkers in a Randomized, Placebo-Controlled, One-Month Clinical Trial in Alzheimer’s Disease Patients.”  

The Company’s CTAD presentation is available on its website: https://www.CassavaSciences.com

Phase 2b Study Design
Phase 2b was a double-blind, randomized, placebo-controlled, multi-center clinical study of sumifilam (formerly, PTI-125). Sixty-four patients with mild-to-moderate Alzheimer’s disease, age 50-85, were randomized (1:1:1) to 100 mg or 50 mg oral sumifilam or matching placebo. Treatment was administered twice daily for 28 days. Nine U.S. study sites enrolled patients. A clinical diagnosis of Alzheimer’s disease was confirmed with the Mini-Mental State Examination (MMSE) ≥16 to ≤26 and a CSF T-tau/Aβ₄₂ ratio ≥0.28. Safety was assessed by ECGs, clinical labs, adverse event monitoring and physical examinations.

Previously Announced Clinical Phase 2b Data
As previously announced in September 2020, sumifilam was safe and well-tolerated, with no drug-related patient discontinuations. Alzheimer’s patients treated with 50 mg or 100 mg sumifilam twice-daily for 28 days showed statistically significant (p<0.05) improvements in eight biomarkers of disease pathology, neurodegeneration and neuroinflammation, versus Alzheimer’s patients who took placebo. In addition, Alzheimer’s patients treated with sumifilam showed improvements in validated tests of Episodic Memory and Spatial Working Memory, versus patients who took placebo (Effect Sizes 17-46%). Cognitive improvements correlated most strongly (R²=0.5) with decreases in P-tau181, a biomarker that leads to tangles in the brain. Sumifilam decreased brain levels of Ptau-181 by 8-11%, versus placebo. The study achieved a 98% response rate, defined as the proportion of study participants taking sumifilam who showed improvements in biomarkers.