Cassava Sciences Announces Completion of Patient Enrollment of a Phase 2b Study in Alzheimer’s Disease
- Category: Proteins and Peptides
- Published on Tuesday, 28 January 2020 18:54
- Hits: 1027
Top-Line Results Expected Mid-year 2020
AUSTIN, TX, USA I January 28, 2020 I Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced it has initiated dosing for the last patient in a Phase 2b study of PTI-125. This completes patient enrollment in a randomized, double-blind, placebo-controlled, Phase 2b study of PTI-125, Cassava Sciences’ investigational drug to treat Alzheimer’s disease. A total of 64 patients were enrolled in this study and top-line results are expected mid-year 2020.
“This study again brought together leaders from the research community who share our commitment to improving outcomes for patients with Alzheimer’s disease,” said Remi Barbier, President & CEO. “Our previously announced results of a Phase 2a study with PTI-125 generated promising biomarker data in Alzheimer’s patients. Based on those positive results, we believe our on-going Phase 2b study is a critical point of clinical validation for PTI-125.”
Cassava Sciences is conducting its Phase 2b study with scientific and financial support from the National Institutes of Health (NIH).
About the Phase 2b Study
Phase 2b is a randomized, double-blind, placebo-controlled, multi-center study of PTI-125 in patients with mild-to-moderate Alzheimer's disease in the United States. Patients receive placebo, 50 mg or 100 mg of PTI-125 twice-daily over 28 days. The objective of this study is to investigate the safety and effects of PTI-125 on biomarkers of disease. The primary endpoint is improvement in patients’ biomarkers of disease from baseline to Day 28. Further information on our Phase 2b study may be found on www.ClinicalTrials.gov (study identifier: NCT04079803).
The target of PTI-125 is an altered form of filamin A (FLNA), a scaffolding protein. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. Cassava Sciences’ lead drug candidate, PTI-125, is a proprietary small molecule that restores the normal shape and function of FLNA in the brain. This action improves the function of certain receptors in the brain, slows neurodegeneration and exerts powerful anti-neuroinflammatory effects. The underlying science for Cassava Sciences’ programs in neurodegeneration is published in prestigious peer-reviewed technical journals, including Journal of Neuroscience, Neurobiology of Aging, and Journal of Biological Chemistry.
Cassava Sciences is also developing an investigational diagnostic, called PTI-125Dx, to detect Alzheimer’s disease with a simple blood test.
About Alzheimer's Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. In the U.S. alone, approximately 5.8 million people are currently living with Alzheimer’s disease, and approximately 487,000 people age 65 or older will develop Alzheimer’s in 2019.1 The number of people living with Alzheimer’s disease is expected to grow dramatically in the years ahead, which may also result in a growing social and economic burden.2
About Cassava Sciences, Inc.
The mission of Cassava Sciences is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. Over the past 10 years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimer’s disease. Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technology, without royalty obligations to any third-party.
1, 2 Source: Alzheimer’s Association. 2019 Alzheimer’s Disease Facts and Figures. Available online at: https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf
SOURCE: Cassava Therapeutics