Cyclo Therapeutics Receives IND Clearance from the U.S. FDA to Advance its Phase 2 Study of Trappsol® Cyclo™ for the Treatment of Alzheimer’s Disease

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Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced it has received notification that its study may proceed from the U.S. Food and Drug Administration (“FDA”) for its initial investigational new drug (“IND”) application for a Phase 2 study of Trappsol® Cyclo™ for the treatment of early Alzheimer’s disease.

Trappsol® Cyclo™ is a proprietary formulation of hydroxypropyl beta cyclodextrin, and in multiple clinical studies, has shown encouraging results to effectively manage the transportation of cholesterol. Many of the known risk factors for Alzheimer’s disease are associated with cholesterol metabolism. Cholesterol imbalance in Alzheimer’s patients is well known, and significant research exists, suggesting these imbalances are responsible for amyloid beta (Aβ) and tau accumulation. Furthermore, neurons, because of their high metabolic demands, experience an increased level of oxidative stress. Oxidative stress has also been linked to abnormal cholesterol accumulation and processing.

Cyclo Therapeutics is currently testing the same investigational Trappsol® Cyclo™ drug in a Phase 3 clinical trial and a long-term extension study for the treatment of Niemann-Pick disease Type C1, a rare, fatal and progressive genetic disorder. Taking the place of the defective NPC1 protein, Trappsol® Cyclo™, with its cyclic structure, facilitates the transport of accumulated cholesterol out of cellular lysosomes so it can be further processed and excreted out of cells. With the biologic similarities demonstrated between Niemann-Pick disease Type C1 and Alzheimer’s Disease, including cholesterol accumulation in regions of the brain, elevated levels of Tau in cerebrospinal fluid (“CSF”), and amyloid plaques in the brain, the Company believes Trappsol® Cyclo™ has significant potential to be an effective treatment option for Alzheimer’s disease.

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