Stage (next event)
End-of-phase 2 (EOP2) meeting with FDA
Catalyst Info & Data Links
TITLE: Sumifilam for Alzheimer's Disease - End-of-phase 2 (EOP2) meeting with FDA
ClinicalTrial.gov (NCT04388254): Sumifilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients (PTI-125)
WHAT IS THE CATALYST EVENT?
1. End-of-phase 2 (EOP2) meeting with FDA
2. Phase 3 Initiation
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
2020: PTI-125 Reduces Biomarkers of Alzheimer’s Disease in Patients. The Journal of Prevention of Alzheimer's Disease, 1-9.
Mechanism of Action
MECHANISM OF ACTION
Sumifilam is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science for sumifilam is published in peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, Neuroimmunology and Neuroinflammation and Journal of Prevention of Alzheimer’s Disease. The Company is also developing an investigational diagnostic, called SavaDx, to detect Alzheimer’s disease with a simple blood test.
Sumifilam and SavaDx were both developed in-house. Both product candidates are substantially funded by peer-review research grant awards from the National Institutes of Health (NIH). Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technologies, without royalty obligations to any third party. Patent protection in this area runs through 2037, plus extensions, and includes seven issued patents and related patent filings and applications.
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 developed Alzheimer’s in 2019. The number of people living with Alzheimer’s disease is expected to grow dramatically in the years ahead, resulting in a growing social and economic burden.
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