CTD Holdings, Inc., a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, announced that the company has initiated planning for a Phase I clinical trial for treatment of Alzheimer’s Disease. The trial will use Trappsol® Cyclo™, the company’s proprietary formulation of hydroxypropyl beta cyclodextrin, administered intravenously.
”Alzheimer’s Disease is a devastating illness for patients and their families. We expect to launch a Phase I trial using Trappsol® Cyclo™ as a first step on our pathway to market approval of Trappsol® Cyclo™ for an Alzheimer’s Disease indication,” said N. Scott Fine, CTD’s Chairman and CEO. ”We are planning to meet with FDA in the near term to discuss our plans.”
The Alzheimer’s Association reports that more than 5 million Americans are living with Alzheimer’s Disease today, and this number could grow to 16 million by 2050. Delaying of the onset of symptoms and slowing of disease progression will save patients and families an enormous toll in human suffering and will have economic benefits to the health care system more broadly.
CTD currently supports a single patient expanded access program using Trappsol® Cyclo™ in late-onset Alzheimer’s Disease, the most common form of the disease (ClinicalTrials.gov NCT03624842). The program is a collaboration with Diana Kerwin, M.D. of the Kerwin Research Center, CA.