CTD Holdings Announces Filing of Data From Expanded Access Program in Late Onset Alzheimer’s Disease in Support of Its Patent Application Filed In 2018

ALACHUA, Fla.–(BUSINESS WIRE)–CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biopharmaceutical company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, announced today that it has filed supporting data for its patent application titled “Methods for Treating Alzheimer’s Disease.” The original patent application was filed October 29, 2018 for the use of hydroxypropyl beta cyclodextrins in the treatment of Alzheimer’s Disease. According to the US Centers for Disease Control and Prevention, there were 5.7 million Americans living with Alzheimer’s Disease in 2018.

“The data filed with the US Patent and Trademark Office are from a single patient suffering from Alzheimer’s Disease who has been intravenously using Trappsol^® Cyclo™, our proprietary hydroxypropyl beta cyclodextrin, for one year,” said N. Scott Fine, CTD’s Chairman and CEO. The patient is using the drug on an expanded access basis (see ClinicalTrials.gov NCT03624842). “As reported to the FDA in a required annual report, the data suggest a positive safety profile in this patient, overall stabilization of disease, and improvement in certain behavioral aspects of the disease.”

The original patent application covers dosing regimens and routes of administration. The patent application lists co-inventors Sharon H. Hrynkow, PhD; Jeffrey L. Tate, PhD; and N. Scott Fine of CTD Holdings.

Hydroxypropyl beta cyclodextrins have been shown to decrease amyloid beta, one of the hallmarks of Alzheimer’s disease, in animal and cell culture studies, and to increase the memory span in a mouse model for Alzheimer’s disease (see J. Yao et al., J. Exp. Med. 2012 vol 209(13):2501-13).

“There is currently no cure for Alzheimer’s Disease and only few treatment options to address symptoms,” said Dr. Hrynkow, CTD’s Chief Scientific Officer and Senior Vice President for Medical Affairs. “Filing data in support of our patent application is an important step forward as we begin development of this drug for an Alzheimer’s indication.”

About CTD Holdings:

CTD Holdings, Inc. is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of disease. The company’s Trappsol^® Cyclo™, an orphan drug designated product in the United States and Europe, is used to treat Niemann-Pick Disease Type C, a rare and fatal genetic disease, on a compassionate use basis as well as in three ongoing formal clinical trials (Clinical Trials.gov NCT02939547, NCT02912793 and NCT03893071). Additional indications for the active ingredient in Trappsol^® Cyclo™ are in development. For additional information, visit the company’s website: www.ctd-holdings.com

Safe Harbor Statement:

This press release contains “forward-looking statements” about the company’s current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual results in future periods to differ materially from what is expressed in, or implied by, these statements. The factors which may influence the company’s future performance include the company’s ability to obtain additional capital to expand operations as planned, success in achieving regulatory approval for clinical protocols, enrollment of adequate numbers of patients in clinical trials, unforeseen difficulties in showing efficacy of the company’s biopharmaceutical products, success in attracting additional customers and profitable contracts, and regulatory risks associated with producing pharmaceutical grade and food products. These and other risk factors are described from time to time in the company’s filings with the Securities and Exchange Commission, including, but not limited to, the company’s reports on Forms 10-K and 10-Q. Unless required by law, the company assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Contacts

RedChip Companies, Inc.

Victor Roberts

407-571-0909

[email protected]