Cyclo Therapeutics Eyes Advancing Phase 2 Study for Alzheimer's Treatment

– Biologic similarities demonstrated between Niemann-Pick Disease Type C and Alzheimer’s Disease, including cholesterol accumulation in regions of the brain, elevated levels of Tau in CSF, and amyloid plaques in the brain, bolsters rationale for studying Trappsol® Cyclo™ for the treatment of early Alzheimer’s Disease

– Phase 2 protocol was developed based clinical data from completed and ongoing trials in Niemann-Pick Disease Type C and on 18 months of data from a single late-onset Alzheimer’s patient being administered monthly intravenous doses of Trappsol® Cyclo™ under compassionate use

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 submitted its initial investigational new drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for a Phase 2 study of Trappsol® Cyclo™ for the treatment of early Alzheimer’s Disease (AD).

"We are excited to have submitted our Initial IND to evaluate Trappsol® Cyclo™ for the treatment of Alzheimer’s Disease. The feedback and recommendations received from our Type B Meeting with the FDA have provided valuable input that we believe positions us for success in advancing this asset. We have taken another step towards commencing our Phase 2 study and, importantly, bringing a much-needed treatment option to patients and families," commented Michael Lisjak, Chief Regulatory Officer, Senior Vice President for Business Development of Cyclo Therapeutics.

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 AD are associated with cholesterol metabolism. Cholesterol imbalance in AD patients is well known, and significant research exists suggesting these imbalances are responsible for 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. AD shares features with NPC-1, a neurovisceral, genetic disease in which cholesterol accumulates in lysosomes, including progressive decline in cognitive ability, amyloid beta plaques in the CNS, and increased levels of tau in the cerebrospinal fluid (CSF). Cyclo Therapeutics is currently testing the same investigational Trappsol® Cyclo™ drug in clinical trials for the treatment of Niemann-Pick Disease Type C1 (NPC-1). Taking the place of the defective NPC-1 protein, Trappsol® Cyclo™, with its cyclic structure, facilitates the transport of accumulated cholesterol out of cellular lysosomes so it can be further processed.

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